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Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes (Onset® 5)

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ClinicalTrials.gov Identifier: NCT02825251
Recruitment Status : Completed
First Posted : July 7, 2016
Results First Posted : July 24, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 1
Interventions Drug: Faster-acting insulin aspart
Drug: insulin aspart
Enrollment 472
Recruitment Details The trial was conducted at 92 sites in 9 countries.as follows: Belgium (7), Canada (8), France (10), Germany (9), Netherlands (9), Russian Federation (11), Slovenia (2), United Kingdom (6), and United States (30). One (1) site in the Netherlands screened, but didn’t randomise any subject.
Pre-assignment Details There was a 4-week run-in period primarily for reinforcement of subject training in trial procedures, diabetes education and collecting baseline assessments. Subjects remained on their pre-trial insulin treatment during the run-in period.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description The subjects received faster aspart (basal-bolus regimen) by continuous subcutaneous insulin infusion (CSII) for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that blood glucose (BG) was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal. The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Period Title: Overall Study
Started 236 236
Completed 233 230
Not Completed 3 6
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             0             1
Withdrawal by Subject             1             4
Unclassified             2             0
Arm/Group Title Faster Aspart NovoRapid Total
Hide Arm/Group Description The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal. The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal. Total of all reporting groups
Overall Number of Baseline Participants 236 236 472
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 236 participants 236 participants 472 participants
43.3  (14.8) 43.6  (14.7) 43.5  (14.7)
[1]
Measure Analysis Population Description: The full analysis (FAS) included all randomised subjects.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 236 participants 236 participants 472 participants
Female
133
  56.4%
136
  57.6%
269
  57.0%
Male
103
  43.6%
100
  42.4%
203
  43.0%
[1]
Measure Analysis Population Description: The FAS included all randomised subjects.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 236 participants 236 participants 472 participants
Hispanic or Latino
7
   3.0%
6
   2.5%
13
   2.8%
Not Hispanic or Latino
210
  89.0%
215
  91.1%
425
  90.0%
Unknown or Not Reported
19
   8.1%
15
   6.4%
34
   7.2%
[1]
Measure Analysis Population Description: The FAS included all randomised subjects.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 236 participants 236 participants 472 participants
American Indian or Alaska Native
0
   0.0%
2
   0.8%
2
   0.4%
Asian
3
   1.3%
3
   1.3%
6
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   0.8%
5
   2.1%
7
   1.5%
White
209
  88.6%
210
  89.0%
419
  88.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
22
   9.3%
16
   6.8%
38
   8.1%
[1]
Measure Analysis Population Description: The FAS included all randomised subjects.
1.Primary Outcome
Title Change in Glycosylated Haemoglobin (HbA1c)
Hide Description Change from baseline (week 0) in HbA1c was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: Percentage (%) of HbA1c
Baseline 7.49  (0.55) 7.49  (0.53)
Change from baseline -0.06  (0.50) -0.14  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faster Aspart, NovoRapid
Comments Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, strata (use of own continuous glucose monitoring), previous insulin use, and region as factors, and baseline HbA1c as a covariate.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of faster aspart was considered confirmed if the upper limit of the two-sided 95 % CI for the true treatment-difference D (faster aspart minus NovoRapid®) was below 0.4 %.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
0.01 to 0.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in 1-hour PPG Increment
Hide Description Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 235 participants 235 participants
4.67  (3.09) 4.62  (3.00)
Change from baseline Number Analyzed 228 participants 227 participants
-0.89  (3.44) 0.05  (3.37)
3.Secondary Outcome
Title Change From Baseline in 1,5-anhydroglucitol
Hide Description Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: ug/mL
Baseline Number Analyzed 233 participants 234 participants
4.20  (2.34) 4.13  (2.14)
Change from baseline Number Analyzed 233 participants 234 participants
0.14  (1.48) 0.25  (1.42)
4.Secondary Outcome
Title Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM
Hide Description Change from baseline (week 0) in low interstitial glucose (IG) (≤3.9 mmol/L [70 mg/dL]) during continuous glucose monitoring (CGM) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: min/day
Baseline Number Analyzed 236 participants 236 participants
85.42  (65.20) 79.88  (60.46)
Change from baseline Number Analyzed 234 participants 231 participants
-6.96  (55.29) 2.85  (58.56)
5.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG)
Hide Description Change from baseline (week 0) in FPG was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 231 participants 233 participants
7.60  (2.64) 7.40  (2.31)
Change from baseline Number Analyzed 231 participants 233 participants
-0.03  (3.19) 0.25  (3.05)
6.Secondary Outcome
Title Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)
Hide Description Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: % of subjects
20.3 23.3
7.Secondary Outcome
Title Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes
Hide Description Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) without treatment emergent severe hypoglycaemic episodes was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of IMP administration after randomisation (in week 0) and no later than one day after the last day on IMP (i.e., maximum week 16 + 1 day). The results are based on the in-trial period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: % of subjects
18.6 22.5
8.Secondary Outcome
Title Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)
Hide Description Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
30-min (Baseline) Number Analyzed 236 participants 234 participants
10.54  (3.33) 10.30  (2.96)
1-hour (Baseline) Number Analyzed 235 participants 235 participants
12.18  (3.96) 11.96  (3.81)
2-hour (Baseline) Number Analyzed 236 participants 235 participants
13.17  (4.77) 13.04  (4.35)
3-hour (Baseline) Number Analyzed 235 participants 233 participants
11.38  (4.65) 11.48  (4.28)
4-hour (Baseline) Number Analyzed 233 participants 231 participants
9.07  (4.31) 9.18  (3.83)
30-min (Change from baseline) Number Analyzed 229 participants 226 participants
-0.50  (4.05) 0.42  (3.75)
1-hour (Change from baseline) Number Analyzed 228 participants 229 participants
-0.85  (4.65) 0.36  (4.58)
2-hour (Change from baseline) Number Analyzed 230 participants 227 participants
-0.80  (5.33) 0.42  (5.01)
3-hour (Change from baseline) Number Analyzed 228 participants 226 participants
-0.33  (5.12) 0.20  (4.75)
4-hour (Change from baseline) Number Analyzed 225 participants 223 participants
0.00  (4.76) 0.21  (4.10)
9.Secondary Outcome
Title Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)
Hide Description Change from baseline (week 0) in 30-min, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and PPG was evaluated after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
30-min (Baseline) Number Analyzed 236 participants 234 participants
3.02  (2.16) 2.95  (2.03)
2-hour (Baseline) Number Analyzed 236 participants 235 participants
5.65  (4.12) 5.70  (3.66)
3-hour (Baseline) Number Analyzed 235 participants 233 participants
3.85  (4.32) 4.13  (3.72)
4-hour (Baseline) Number Analyzed 233 participants 231 participants
1.57  (4.23) 1.83  (3.52)
30-min (Change from baseline) Number Analyzed 229 participants 224 participants
-0.53  (2.47) 0.11  (2.25)
2-hour (Change from baseline) Number Analyzed 230 participants 225 participants
-0.82  (4.39) 0.09  (4.13)
3-hour (Change from baseline) Number Analyzed 228 participants 224 participants
-0.35  (4.53) -0.14  (4.07)
4-hour (Change from baseline) Number Analyzed 225 participants 221 participants
0.01  (4.50) -0.11  (3.76)
10.Secondary Outcome
Title Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile
Hide Description Change from baseline (week 0) in mean of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-7-9 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 208 participants 209 participants
9.24  (1.71) 9.10  (1.40)
Change from baseline Number Analyzed 196 participants 196 participants
0.19  (1.91) 0.10  (1.58)
11.Secondary Outcome
Title Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)
Hide Description Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Breakfast (baseline) Number Analyzed 188 participants 189 participants
10.82  (2.99) 10.28  (3.07)
Lunch (baseline) Number Analyzed 191 participants 197 participants
9.65  (3.05) 9.62  (2.68)
Main evening meal (baseline) Number Analyzed 194 participants 194 participants
9.79  (3.01) 9.34  (3.06)
Mean over all meals (baseline) Number Analyzed 168 participants 171 participants
10.07  (2.09) 9.74  (1.99)
Breakfast (Change from baseline) Number Analyzed 177 participants 176 participants
-0.33  (3.61) 0.23  (3.79)
Lunch (Change from baseline) Number Analyzed 177 participants 181 participants
0.27  (3.75) 0.05  (3.57)
Main evening meal (Change from baseline) Number Analyzed 174 participants 175 participants
-0.35  (3.81) 0.58  (3.61)
Mean over all meals (Change from baseline) Number Analyzed 147 participants 152 participants
0.06  (2.33) 0.13  (2.21)
12.Secondary Outcome
Title Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)
Hide Description Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Breakfast (baseline) Number Analyzed 182 participants 184 participants
2.62  (3.16) 1.93  (3.28)
Lunch (baseline) Number Analyzed 186 participants 189 participants
1.80  (2.77) 1.77  (2.47)
Main evening meal (baseline) Number Analyzed 186 participants 191 participants
1.04  (3.07) 0.52  (2.69)
Mean over all meals (baseline) Number Analyzed 156 participants 164 participants
1.93  (1.94) 1.48  (1.86)
Breakfast (Change from baseline) Number Analyzed 167 participants 167 participants
-0.75  (3.90) 0.03  (3.67)
Lunch (Change from baseline) Number Analyzed 171 participants 171 participants
-0.43  (3.25) -0.27  (3.13)
Main evening meal (Change from baseline) Number Analyzed 163 participants 171 participants
-0.47  (3.51) 0.35  (3.79)
Mean over all meals (Change from baseline) Number Analyzed 131 participants 139 participants
-0.53  (1.99) 0.12  (1.92)
13.Secondary Outcome
Title Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)
Hide Description Change from baseline (week 0) in pre-prandial PG (pre-breakfast, pre-lunch, pre-main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Pre-breakfast (baseline) Number Analyzed 204 participants 206 participants
8.40  (2.50) 8.31  (2.32)
Pre-lunch (baseline) Number Analyzed 207 participants 207 participants
8.28  (2.85) 8.21  (2.32)
Pre-main evening meal (baseline) Number Analyzed 203 participants 208 participants
8.68  (2.76) 8.87  (2.62)
Pre-mean over all meals (baseline) Number Analyzed 199 participants 205 participants
8.39  (1.73) 8.45  (1.54)
Pre-breakfast (Change from baseline) Number Analyzed 192 participants 192 participants
0.36  (3.33) 0.26  (3.05)
Pre-lunch (Change from baseline) Number Analyzed 195 participants 193 participants
0.39  (3.54) 0.21  (3.12)
Pre-main evening meal (Change from baseline) Number Analyzed 189 participants 194 participants
0.15  (3.72) 0.13  (3.18)
Pre-mean over all meals (Change from baseline) Number Analyzed 185 participants 189 participants
0.39  (2.00) 0.21  (1.84)
14.Secondary Outcome
Title Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile
Hide Description Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-7-9 point SMPG profile at baseline (week 0) and after 16 weeks of randomisation (i.e., week 16). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Median (Full Range)
Unit of Measure: mmol/L
Baseline Number Analyzed 208 participants 209 participants
2.14
(0.4 to 4.9)
2.05
(0.9 to 4.0)
Last in-trial value Number Analyzed 212 participants 214 participants
2.06
(0.9 to 5.2)
2.06
(0.7 to 3.8)
15.Secondary Outcome
Title Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements
Hide Description Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
04:00 to breakfast (Baseline) Number Analyzed 176 participants 181 participants
-1.29  (3.61) -1.06  (3.35)
Bedtime to 04:00 (Baseline) Number Analyzed 167 participants 174 participants
-0.97  (5.16) -0.56  (3.84)
Bedtime to breakfast (Baseline) Number Analyzed 193 participants 195 participants
-1.73  (4.81) -1.56  (3.83)
04:00 to breakfast (Change from baseline) Number Analyzed 152 participants 165 participants
-0.50  (4.83) -0.08  (4.45)
Bedtime to 04:00 (Change from baseline) Number Analyzed 144 participants 155 participants
0.81  (6.59) 0.18  (5.14)
Bedtime to breakfast (Change from baseline) Number Analyzed 182 participants 179 participants
0.13  (6.67) -0.20  (5.84)
16.Secondary Outcome
Title Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]
Hide Description Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: % of subjects
8.1 7.6
17.Secondary Outcome
Title Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia
Hide Description Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without treatment emergent severe hypoglycaemia was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. The results are based on the in-trial period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: % of subjects
7.6 6.8
18.Secondary Outcome
Title Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)
Hide Description Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values at baseline (week 0) and after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Median (Full Range)
Unit of Measure: mmol/L
Total cholesterol (Baseline)
4.48
(2.6 to 8.1)
4.68
(2.9 to 8.0)
High density lipoproteins (Baseline)
1.70
(0.8 to 3.3)
1.71
(0.8 to 3.8)
Low density lipoproteins (Baseline)
2.46
(1.1 to 6.4)
2.63
(1.2 to 6.6)
Total cholesterol (Last in-trial value)
4.61
(2.8 to 7.2)
4.57
(2.4 to 8.2)
High density lipoproteins (Last in-trial value)
1.74
(0.9 to 3.1)
1.74
(0.7 to 3.6)
Low density lipoproteins (Last in-trial value)
2.56
(1.0 to 5.2)
2.59
(1.1 to 6.4)
19.Secondary Outcome
Title Insulin Dose in Units/Day: Total Basal
Hide Description Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised trial products (faster aspart and NovoRapid®) to no later than 7 days after the day of last dose of randomised trial products.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the investigational medicinal product (IMP, faster aspart) or its comparator (NovoRapid®/NovoLog®). Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: Unit (U)
23.82  (12.82) 23.87  (11.38)
20.Secondary Outcome
Title Insulin Dose in Units/Day: Total Bolus
Hide Description Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: U
25.91  (17.46) 25.27  (15.33)
21.Secondary Outcome
Title Insulin Dose in Units/Day: Total Daily Insulin Dose
Hide Description Total insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: U
49.72  (27.08) 49.12  (23.75)
22.Secondary Outcome
Title Insulin Dose in Units/Day: Individual Meal Insulin Dose
Hide Description No data was collected for individual meal insulin dose.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were analysed, as no data was collected for individual meal insulin dose.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Insulin Dose in Units/kg/Day: Total Basal
Hide Description Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: U/Kg
0.30  (0.12) 0.30  (0.11)
24.Secondary Outcome
Title Insulin Dose in Units/kg/Day: Total Bolus
Hide Description Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: U/Kg
0.33  (0.17) 0.31  (0.16)
25.Secondary Outcome
Title Insulin Dose in Units/kg/Day: Total Daily Insulin Dose
Hide Description Total insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: U/Kg
0.63  (0.24) 0.61  (0.23)
26.Secondary Outcome
Title Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose
Hide Description No data was collected for individual meal insulin dose.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were analysed, as no data was collected for individual meal insulin dose.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio
Hide Description Insulin carbohydrate ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: Gram (g)/U
9.13  (3.20) 9.74  (6.77)
28.Secondary Outcome
Title Insulin Delivery Pump Parameter: Glucose Sensitivity Factor
Hide Description Glucose sensitivity factor was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L/U
2.65  (1.14) 2.60  (0.98)
29.Secondary Outcome
Title Insulin Delivery Pump Parameter: Active Insulin Time
Hide Description Active insulin time was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: Hour (h)
3.6  (0.7) 3.6  (0.7)
30.Secondary Outcome
Title Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)
Hide Description Change from baseline (week 0) in mean interstitial glucose (IG) increment (0-30 minutes (min), 0-1 hour (h) and 0-2 h after start of meal) (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Breakfast 0-30 min (Baseline) Number Analyzed 229 participants 230 participants
0.23  (0.61) 0.21  (0.60)
Lunch 0-30 min (Baseline) Number Analyzed 230 participants 231 participants
0.02  (0.54) 0.03  (0.60)
Main evening meal 0-30 min (Baseline) Number Analyzed 231 participants 231 participants
0.15  (0.52) 0.09  (0.57)
Mean across all meals 0-30 min (Baseline) Number Analyzed 228 participants 230 participants
0.13  (0.37) 0.11  (0.39)
Breakfast 0-1 h (Baseline) Number Analyzed 229 participants 230 participants
0.78  (0.97) 0.73  (0.94)
Lunch 0-1 h (Baseline) Number Analyzed 230 participants 231 participants
0.42  (0.77) 0.44  (0.84)
Main evening meal 0-1 h (Baseline) Number Analyzed 231 participants 231 participants
0.39  (0.75) 0.32  (0.82)
Mean across all meals 0-1 h (Baseline) Number Analyzed 228 participants 230 participants
0.52  (0.57) 0.50  (0.60)
Breakfast 0-2 h (Baseline) Number Analyzed 229 participants 230 participants
1.32  (1.52) 1.27  (1.46)
Lunch 0-2 h (Baseline) Number Analyzed 230 participants 231 participants
0.99  (1.19) 0.92  (1.07)
Main evening meal 0-2 h (Baseline) Number Analyzed 231 participants 231 participants
0.54  (1.15) 0.50  (1.19)
Mean across all meals 0-2 h (Baseline) Number Analyzed 228 participants 230 participants
0.93  (0.94) 0.89  (0.84)
Breakfast 0-30 min (Change from baseline) Number Analyzed 225 participants 221 participants
-0.03  (0.80) 0.08  (0.67)
Lunch 0-30 min (Change from baseline) Number Analyzed 226 participants 223 participants
0.05  (0.61) 0.10  (0.68)
Main evening meal 0-30 min (Change from baseline) Number Analyzed 227 participants 223 participants
-0.07  (0.73) -0.01  (0.70)
Mean across all meals 0-30min:Change from baseline Number Analyzed 224 participants 221 participants
-0.01  (0.46) 0.06  (0.46)
Breakfast 0-1 h (Change from baseline) Number Analyzed 225 participants 221 participants
-0.13  (1.13) 0.14  (0.99)
Lunch 0-1 h (Change from baseline) Number Analyzed 226 participants 223 participants
-0.02  (0.88) 0.15  (0.99)
Main evening meal 0-1 h (Change from baseline) Number Analyzed 227 participants 223 participants
-0.16  (0.95) 0.04  (0.97)
Mean across all meals 0-1 h (Change from baseline) Number Analyzed 224 participants 221 participants
-0.10  (0.61) 0.11  (0.66)
Breakfast 0-2 h (Change from baseline) Number Analyzed 225 participants 221 participants
-0.28  (1.60) 0.16  (1.45)
Lunch 0-2 h (Change from baseline) Number Analyzed 226 participants 223 participants
-0.24  (1.32) 0.22  (1.37)
Main evening meal 0-2 h (Change from baseline) Number Analyzed 227 participants 223 participants
-0.29  (1.29) -0.03  (1.27)
Mean across all meals 0-2 h (Change from baseline) Number Analyzed 224 participants 221 participants
-0.25  (0.81) 0.12  (0.86)
31.Secondary Outcome
Title Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)
Hide Description Change from baseline (week 0) in mean time to the IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: Minutes
Breakfast (Baseline) Number Analyzed 229 participants 231 participants
88.95  (25.66) 97.29  (32.32)
Lunch (Baseline) Number Analyzed 230 participants 231 participants
109.47  (31.78) 106.94  (29.67)
Main evening meal (Baseline) Number Analyzed 231 participants 232 participants
110.11  (32.35) 106.91  (29.61)
Mean across all meals (Baseline) Number Analyzed 231 participants 232 participants
103.24  (18.50) 103.99  (19.21)
Breakfast (Change from baseline) Number Analyzed 225 participants 222 participants
0.25  (33.69) -4.03  (35.49)
Lunch (Change from baseline) Number Analyzed 226 participants 223 participants
-2.00  (38.63) 1.64  (38.02)
Main evening meal (Change from baseline) Number Analyzed 227 participants 223 participants
-2.04  (40.51) -1.43  (38.94)
Mean across all meals (Change from baseline) Number Analyzed 227 participants 223 participants
-1.30  (22.01) -1.00  (21.90)
32.Secondary Outcome
Title Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)
Hide Description Change from baseline (week 0) in mean IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Breakfast (Baseline) Number Analyzed 229 participants 231 participants
12.43  (1.97) 12.25  (2.09)
Lunch (Baseline) Number Analyzed 230 participants 231 participants
12.42  (2.07) 12.56  (1.84)
Main evening meal (Baseline) Number Analyzed 231 participants 232 participants
12.65  (2.10) 12.70  (2.06)
Mean across all meals (Baseline) Number Analyzed 231 participants 232 participants
12.49  (1.67) 12.51  (1.60)
Breakfast (Change from baseline) Number Analyzed 225 participants 222 participants
0.10  (2.24) 0.11  (2.11)
Lunch (Change from baseline) Number Analyzed 226 participants 223 participants
0.10  (2.19) 0.19  (1.92)
Main evening meal (Change from baseline) Number Analyzed 227 participants 223 participants
0.22  (2.09) -0.13  (2.14)
Mean across all meals (Change from baseline) Number Analyzed 227 participants 223 participants
0.16  (1.63) 0.03  (1.59)
33.Secondary Outcome
Title Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])
Hide Description Percentage of time spent with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: % of time
IG ≤2.5 mmol/L (45 mg/dL) Number Analyzed 234 participants 231 participants
1.11  (1.29) 1.03  (1.38)
IG ≤3.0 mmol/L (54 mg/dL) Number Analyzed 234 participants 231 participants
2.15  (1.98) 2.19  (2.25)
IG ≤3.5 mmol/L (63 mg/dL) Number Analyzed 234 participants 231 participants
3.75  (2.85) 3.93  (3.37)
IG ≤3.9 mmol/L (70.2 mg/dL) Number Analyzed 234 participants 231 participants
5.46  (3.68) 5.76  (4.25)
IG >10.0 mmol/L (180 mg/dL) Number Analyzed 234 participants 231 participants
41.57  (13.09) 39.24  (11.86)
IG >12.0 mmol/L (216 mg/dL) Number Analyzed 234 participants 231 participants
26.34  (11.66) 24.23  (10.75)
IG >13.9 mmol/L (250 mg/dL) Number Analyzed 234 participants 231 participants
15.87  (9.42) 14.23  (8.49)
34.Secondary Outcome
Title Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])
Hide Description Incidence of episodes with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of Events
IG ≤2.5 mmol/L (45 mg/dL) Number Analyzed 208 participants 205 participants
1570 1532
IG ≤3.0 mmol/L (54 mg/dL) Number Analyzed 226 participants 222 participants
2848 2920
IG ≤3.5 mmol/L (63 mg/dL) Number Analyzed 232 participants 227 participants
4584 4742
IG ≤3.9 mmol/L (70 mg/dL) Number Analyzed 234 participants 229 participants
6371 6576
IG >10.0 mmol/L (180 mg/dL) Number Analyzed 234 participants 231 participants
35194 33176
IG >12.0 mmol/L (216 mg/dL) Number Analyzed 234 participants 231 participants
23070 21276
IG >13.9 mmol/L (250 mg/dL) Number Analyzed 234 participants 231 participants
14352 12866
35.Secondary Outcome
Title Change From Baseline in Mean of the IG Profile
Hide Description Change from baseline (week 0) in mean of the IG profile was evaluated after 16 weeks of randomisation. The mean of an IG profile is defined as the time integral of the profile over the profile's length, divided by the profile's length. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 236 participants 236 participants
9.38  (1.18) 9.39  (1.20)
Change from baseline Number Analyzed 234 participants 231 participants
0.28  (1.27) 0.04  (1.18)
36.Secondary Outcome
Title Percentage of Time Spent Within IG Target Range 4.0–7.8 mmol/L (71–140 mg/dL) and 4.0-10 mmol/L (71–180 mg/dL)
Hide Description Percentage of time spent within IG target range 4.0–7.8 mmol/L (71–140 mg/dL) and 4.0-10 mmol/L (71–180 mg/dL) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: % of time
IG 4.0-7.8 mmol/L (71-140 mg/dL) Number Analyzed 234 participants 231 participants
31.49  (9.97) 33.11  (8.76)
IG 4.0-10.0 mmol/L (71-180 mg/dL) Number Analyzed 234 participants 231 participants
52.40  (11.87) 54.40  (10.70)
37.Secondary Outcome
Title Variation in the IG Profile
Hide Description Variation in IG profile was the average absolute difference from the mean of the IG profile. Variation in the IG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Median (Full Range)
Unit of Measure: mmol/L
3.09
(1.6 to 5.6)
3.04
(1.6 to 5.1)
38.Secondary Outcome
Title Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]
Hide Description Area under the curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL] was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
3.19  (0.22) 3.21  (0.20)
39.Secondary Outcome
Title Change From Baseline in AUCIG,0-15min
Hide Description Change from baseline (week 0) in area under the curve for interstitial glucose (AUCIG),0-15 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 221 participants 228 participants
7.55  (2.63) 7.37  (2.20)
Change from baseline Number Analyzed 203 participants 198 participants
0.16  (3.06) 0.21  (2.96)
40.Secondary Outcome
Title Change From Baseline in AUCIG,0-30min
Hide Description Change from baseline (week 0) in AUCIG,0-30 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 221 participants 228 participants
7.98  (2.65) 7.86  (2.25)
Change from baseline Number Analyzed 205 participants 198 participants
0.12  (3.12) 0.22  (3.02)
41.Secondary Outcome
Title Change From Baseline in AUCIG,0-1h
Hide Description Change from baseline (week 0) in AUCIG,0-1 hour during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 221 participants 228 participants
9.47  (2.76) 9.35  (2.38)
Change from baseline Number Analyzed 207 participants 200 participants
-0.07  (3.33) 0.32  (3.26)
42.Secondary Outcome
Title Change From Baseline in AUCIG,0-2h
Hide Description Change from baseline (week 0) in AUCIG,0-2 hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 225 participants 228 participants
11.27  (3.10) 11.18  (2.82)
Change from baseline Number Analyzed 211 participants 206 participants
-0.38  (3.76) 0.37  (3.90)
43.Secondary Outcome
Title Change From Baseline in AUCIG,0-4h
Hide Description Change from baseline (week 0) in AUCIG,0-24hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 226 participants 229 participants
11.31  (3.33) 11.40  (3.03)
Change from baseline Number Analyzed 215 participants 210 participants
-0.32  (4.07) 0.29  (4.10)
44.Secondary Outcome
Title Change From Baseline in Time to the IG Peak After Start of Meal
Hide Description Change from baseline (week 0) in time to the IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: Minute
Baseline Number Analyzed 226 participants 229 participants
111.2  (45.3) 117.0  (43.0)
Change from baseline Number Analyzed 215 participants 210 participants
1.2  (50.5) -1.4  (51.6)
45.Secondary Outcome
Title Change From Baseline in IG Peak After Start of Meal
Hide Description Change from baseline (week 0) in IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 226 participants 229 participants
14.71  (3.94) 14.69  (3.65)
Change from baseline Number Analyzed 215 participants 210 participants
-0.57  (4.69) 0.36  (4.78)
46.Secondary Outcome
Title Number of Treatment Emergent Adverse Events (AEs)
Hide Description Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 16. A TEAE was defined as an event that has an onset date on or after the first day of exposure to randomised treatment (in week 0), and no later than seven days after the last day of randomised treatment (i.e., maximum week 16 + 7 days). The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of adverse events
440 412
47.Secondary Outcome
Title Number of Treatment Emergent Infusion Site Reactions
Hide Description Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of infusion site reaction events
44 32
48.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall
Hide Description

ADA classification of hypo:

  1. Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.
  2. Documented symptomatic: PG ≤3.9 mmol/L with symptoms.
  3. Asymptomatic: PG ≤3.9 mmol/L without symptoms.
  4. Probable symptomatic: No measurement with symptoms.
  5. Pseudo: PG >3.9 mmol/L with symptoms.
  6. Unclassifiable.

NN classification of hypo:

  1. BG confirmed: PG <3.1 mmol/L with/without symptoms.
  2. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms.
  3. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms.
  4. Unclassifiable.

Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypo.

Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis. The results are based on the on-treatment period.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 21 7
ADA: Documented symptomatic 8372 8904
ADA: Asymptomatic 2530 2273
ADA: Probable symptomatic 88 32
ADA: Pseudo 56 159
ADA: Unclassifiable 1 0
NN: BG confirmed 3258 3240
NN: Severe or BG confirmed symptomatic 2751 2779
NN: Severe or BG confirmed 3279 3247
NN: Unclassifiable 7789 8128
Not able to selftreat - unclassifiable 0 0
49.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 – Inclusive)
Hide Description Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 12 5
ADA: Documented symptomatic 7508 7889
ADA: Asymptomatic 2321 2071
ADA: Probable symptomatic 70 26
ADA: Pseudo 52 144
ADA: Unclassifiable 0 0
NN: BG confirmed 2799 2769
NN: Severe or BG confirmed symptomatic 2335 2359
NN: Severe or BG confirmed 2811 2774
NN: Unclassifiable 7152 7361
Not able to selftreat - unclassifiable 0 0
50.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 – Inclusive)
Hide Description Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 9 2
ADA: Documented symptomatic 864 1015
ADA: Asymptomatic 209 202
ADA: Probable symptomatic 18 6
ADA: Pseudo 4 15
ADA: Unclassifiable 1 0
NN: BG confirmed 459 471
NN: Severe or BG confirmed symptomatic 416 420
NN: Severe or BG confirmed 468 473
NN: Unclassifiable 637 767
Not able to selftreat - unclassifiable 0 0
51.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal
Hide Description Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 0 0
ADA: Documented symptomatic 224 190
ADA: Asymptomatic 31 33
ADA: Probable symptomatic 1 3
ADA: Pseudo 0 5
ADA: Unclassifiable 0 0
NN: BG confirmed 92 51
NN: Severe or BG confirmed symptomatic 81 48
NN: Severe or BG confirmed 92 51
NN: Unclassifiable 164 180
Not able to selftreat - unclassifiable 0 0
52.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal
Hide Description Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 0 0
ADA: Documented symptomatic 1258 1077
ADA: Asymptomatic 176 175
ADA: Probable symptomatic 9 6
ADA: Pseudo 7 34
ADA: Unclassifiable 0 0
NN: BG confirmed 482 413
NN: Severe or BG confirmed symptomatic 441 372
NN: Severe or BG confirmed 482 413
NN: Unclassifiable 968 879
Not able to selftreat - unclassifiable 0 0
53.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal
Hide Description Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 5 2
ADA: Documented symptomatic 3767 3907
ADA: Asymptomatic 750 677
ADA: Probable symptomatic 43 17
ADA: Pseudo 29 98
ADA: Unclassifiable 0 0
NN: BG confirmed 1403 1399
NN: Severe or BG confirmed symptomatic 1246 1259
NN: Severe or BG confirmed 1408 1401
NN: Unclassifiable 3186 3300
Not able to selftreat - unclassifiable 0 0
54.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal
Hide Description Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 5 2
ADA: Documented symptomatic 2509 2830
ADA: Asymptomatic 574 502
ADA: Probable symptomatic 34 11
ADA: Pseudo 22 64
ADA: Unclassifiable 0 0
NN: BG confirmed 921 986
NN: Severe or BG confirmed symptomatic 805 887
NN: Severe or BG confirmed 926 988
NN: Unclassifiable 2218 2421
Not able to selftreat - unclassifiable 0 0
55.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal
Hide Description Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 1 hour to 2 hours after start of the meal. The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 0 0
ADA: Documented symptomatic 1034 887
ADA: Asymptomatic 145 142
ADA: Probable symptomatic 8 3
ADA: Pseudo 7 29
ADA: Unclassifiable 0 0
NN: BG confirmed 390 362
NN: Severe or BG confirmed symptomatic 360 324
NN: Severe or BG confirmed 390 362
NN: Unclassifiable 804 699
Not able to selftreat - unclassifiable 0 0
56.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal
Hide Description Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 3 hours after start of the meal. The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 2 1
ADA: Documented symptomatic 1327 1518
ADA: Asymptomatic 277 241
ADA: Probable symptomatic 19 7
ADA: Pseudo 13 38
ADA: Unclassifiable 0 0
NN: BG confirmed 491 555
NN: Severe or BG confirmed symptomatic 429 508
NN: Severe or BG confirmed 493 556
NN: Unclassifiable 1145 1249
Not able to selftreat - unclassifiable 0 0
57.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal
Hide Description Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 3 to 4 hours after start of the meal. The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 3 1
ADA: Documented symptomatic 1182 1312
ADA: Asymptomatic 297 261
ADA: Probable symptomatic 15 4
ADA: Pseudo 9 26
ADA: Unclassifiable 0 0
NN: BG confirmed 430 431
NN: Severe or BG confirmed symptomatic 376 379
NN: Severe or BG confirmed 433 432
NN: Unclassifiable 1073 1172
Not able to selftreat - unclassifiable 0 0
58.Secondary Outcome
Title Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)
Hide Description Unexplained hyperglycaemia was defined as a confirmed PG value ≥16.7 mmol/L (300 mg/dL) and was unexplained (i.e. no apparent medical, dietary, insulin dosage or pump failure reason). The results are based on the on-treatment period.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
1185 1058
59.Secondary Outcome
Title Change From Baseline in Physical Examination: Respiratory System
Hide Description Reported results are respiratory system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of subjects
Normal, baseline 234 235
Abnormal (NCS), baseline 1 1
Abnormal (CS), baseline 1 0
Normal, last on-treatment value 235 234
Abnormal (NCS), last on-treatment value 0 2
Abnormal (CS), last on-treatment value 1 0
60.Secondary Outcome
Title Change From Baseline in Physical Examination: Cardiovascular System
Hide Description Reported results are cardiovascular system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of subjects
Normal, baseline 233 229
Abnormal (NCS), baseline 1 7
Abnormal (CS), baseline 2 0
Normal, last on-treatment value 231 228
Abnormal (NCS), last on-treatment value 4 7
Abnormal (CS), last on-treatment value 1 1
61.Secondary Outcome
Title Change From Baseline in Physical Examination: Central and Peripheral Nervous System
Hide Description Reported results are central and peripheral nervous system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of subjects
Normal, baseline 210 215
Abnormal (NCS), baseline 22 18
Abnormal (CS), baseline 4 3
Normal, last on-treatment value 209 216
Abnormal (NCS), last on-treatment value 23 17
Abnormal (CS), last on-treatment value 4 3
62.Secondary Outcome
Title Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth
Hide Description Reported results are gastrointestinal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of subjects
Normal, baseline 231 231
Abnormal (NCS), baseline 3 5
Abnormal (CS), baseline 2 0
Normal, last on-treatment value 231 231
Abnormal (NCS), last on-treatment value 4 3
Abnormal (CS), last on-treatment value 1 2
63.Secondary Outcome
Title Change From Baseline in Physical Examination: Musculoskeletal System
Hide Description Reported results are musculoskeletal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of subjects
Normal, baseline 222 227
Abnormal (NCS), baseline 13 9
Abnormal (CS), baseline 1 0
Normal, last on-treatment value 223 228
Abnormal (NCS), last on-treatment value 12 8
Abnormal (CS), last on-treatment value 1 0
64.Secondary Outcome
Title Change From Baseline in Physical Examination: Skin
Hide Description Reported results are skin-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of subjects
Normal, baseline 212 211
Abnormal (NCS), baseline 18 22
Abnormal (CS), baseline 6 3
Normal, last on-treatment value 204 203
Abnormal (NCS), last on-treatment value 21 29
Abnormal (CS), last on-treatment value 11 4
65.Secondary Outcome
Title Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck
Hide Description Reported results are head, ears, eyes, nose, throat and neck-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of subjects
Normal, baseline 219 221
Abnormal (NCS), baseline 15 14
Abnormal (CS), baseline 2 1
Normal, last on-treatment value 217 218
Abnormal (NCS), last on-treatment value 15 16
Abnormal (CS), last on-treatment value 4 2
66.Secondary Outcome
Title Change From Baseline in Vital Sign: Blood Pressure
Hide Description Change from baseline (week 0) in blood pressure (both systolic and diastolic) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic blood pressure (baseline) 123.6  (14.7) 122.0  (14.3)
Diastolic blood pressure (baseline) 74.8  (9.4) 74.6  (8.7)
Systolic blood pressure (change from baseline) -0.8  (12.3) -0.7  (11.5)
Diastolic blood pressure (change from baseline) -0.7  (8.4) -0.4  (7.7)
67.Secondary Outcome
Title Change From Baseline in Vital Sign: Pulse
Hide Description Change from baseline (week 0) in pulse was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: Beats/minute
Baseline 73.7  (11.0) 74.5  (11.1)
Change from baseline -0.5  (9.0) -0.8  (9.6)
68.Secondary Outcome
Title Change From Screening in Electrocardiogram (ECG)
Hide Description Reported results are ECG findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of subjects
Normal, screening Number Analyzed 236 participants 236 participants
178 181
Abnormal (NCS), screening Number Analyzed 236 participants 236 participants
58 54
Abnormal (CS), screening Number Analyzed 236 participants 236 participants
0 1
Normal, last on-treatment value Number Analyzed 232 participants 230 participants
188 180
Abnormal (NCS), last on-treatment value Number Analyzed 232 participants 230 participants
44 48
Abnormal (CS), last on-treatment value Number Analyzed 232 participants 230 participants
0 2
69.Secondary Outcome
Title Change From Screening in Fundus Photography/Fundoscopy
Hide Description Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) AAbnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Measure Type: Number
Unit of Measure: Number of subjects
Left eye (Normal), screening Number Analyzed 236 participants 236 participants
135 136
Left eye (Abnormal [NCS]), screening Number Analyzed 236 participants 236 participants
94 94
Left eye (Abnormal [CS]), screening Number Analyzed 236 participants 236 participants
7 6
Right eye (Normal), screening Number Analyzed 236 participants 236 participants
132 132
Right eye (Abnormal [NCS]), screening Number Analyzed 236 participants 236 participants
98 98
Right eye (Abnormal [CS]), screening Number Analyzed 236 participants 236 participants
6 6
Left eye (Normal), last on-treatment value Number Analyzed 217 participants 208 participants
130 119
Left eye (Abnormal [NCS]), last on-treatment value Number Analyzed 217 participants 208 participants
77 82
Left eye (Abnormal [CS] last on-treatment value Number Analyzed 217 participants 208 participants
10 7
Right eye (Normal), last on-treatment value Number Analyzed 217 participants 208 participants
127 114
Right eye (Abnormal-NCS), last on-treatment value Number Analyzed 217 participants 208 participants
80 87
Right eye (Abnormal [CS]), last on-treatment value Number Analyzed 217 participants 208 participants
10 7
70.Secondary Outcome
Title Change From Baseline in Haematology: Haemoglobin
Hide Description Change from baseline (week 0) in haemoglobin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0–6.0 mmol/L [71–108 mg/dL] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal.
Overall Number of Participants Analyzed 236 236
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline 8.62  (0.82) 8.62  (0.80)
Change from baseline -0.01  (0.48) -0.06  (0.40)
71.Secondary Outcome
Title Change From Baseline in Haematology: Haematocrit
Hide Description Change from baseline (week 0) in haematocrit was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
Arm/Group Title Faster Aspart NovoRapid