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Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial (MIXING)

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ClinicalTrials.gov Identifier: NCT00542620
Recruitment Status : Completed
First Posted : October 11, 2007
Results First Posted : January 18, 2013
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 1
Interventions Drug: insulin detemir
Drug: insulin aspart
Enrollment 25
Recruitment Details Four centres in France
Pre-assignment Details Children with type 1 diabetes currently treated with insulin detemir and insulin aspart and with a good glycaemic control. At trial entry, subjects must be 6-18 years old with a HbA1c (glycosylated haemoglobin) below or equal to 8.6%
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Period Title: Overall Study
Started 13 12
Exposed to Drug 12 [1] 13 [1]
Completed 13 12
Not Completed 0 0
[1]
One subject randomly assigned to receive mixed injections, but received a separate injection mode
Arm/Group Title Mixed Injection Separate Injection Total
Hide Arm/Group Description Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed Total of all reporting groups
Overall Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants
11.6  (2.6) 10.9  (2.5) 11.3  (2.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
5
  38.5%
7
  58.3%
12
  48.0%
Male
8
  61.5%
5
  41.7%
13
  52.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 13 participants 12 participants 25 participants
13 12 25
Diabetes history   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants
6.68  (3.51) 6.13  (2.38) 6.42  (2.97)
[1]
Measure Description: Number of years since diagnosis
1.Primary Outcome
Title Glycosylated Haemoglobin A1c (HbA1c)
Hide Description Measured for the Per Protocol (PP) set
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) analysis set consists of all the ITT (Intention-to-Treat) subjects who did not present any significant protocol deviations that could potentially affect the efficacy results. One subject was excluded from PP as subject received separate injections despite being randomised to receive mixed injections.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: percentage of total haemoglobin
Week 0 8.00  (0.54) 7.77  (0.55)
Week 8 7.63  (0.55) 8.15  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D>0.25% against HA: D=<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).
Statistical Test of Hypothesis P-Value 0.001
Comments If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated
Method ANCOVA
Comments Baseline HbA1c as covariate
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.691
Confidence Interval 95%
-1.049 to -0.334
Estimation Comments [Not Specified]
2.Primary Outcome
Title Glycosylated Haemoglobin A1c (HbA1c)
Hide Description Measured for the ITT (Intention-to-Treat) set
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: percentage of total haemoglobin
Week 0 7.93  (0.57) 7.77  (0.55)
Week 8 7.65  (0.53) 8.15  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D>0.25% against HA: D=<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).
Statistical Test of Hypothesis P-Value 0.003
Comments If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated.
Method ANCOVA
Comments Baseline HbA1c as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.594
Confidence Interval 95%
-0.970 to -0.219
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Fructosamine
Hide Description [Not Specified]
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: mmol/L
Week 0, n=13, 12 334.8  (35.9) 319.8  (22.6)
Week 8, n=12, 12 316.4  (30.1) 334.8  (41.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.573
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline fructosamine and the change in insulin administration mode
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.35
Confidence Interval 95%
-38.77 to 22.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 14.59
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Self-measured Plasma Glucose Profile (Before Breakfast)
Hide Description [Not Specified]
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0 190.31  (56.80) 165.39  (70.28)
Week 8 162.96  (57.46) 204.75  (59.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
5.Secondary Outcome
Title Self-measured Plasma Glucose Profile (After Breakfast)
Hide Description [Not Specified]
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 5 7
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0, n=5, 6 123.00  (61.9) 164.89  (73.33)
Week 8, n=4, 7 208.08  (48.19) 167.98  (70.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.389
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
6.Secondary Outcome
Title Self-measured Plasma Glucose Profile (Before Dinner)
Hide Description [Not Specified]
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0 199.14  (42.05) 201.44  (57.50)
Week 8 185.23  (66.30) 181.03  (68.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.856
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
7.Secondary Outcome
Title Self-measured Plasma Glucose Profile (After Dinner)
Hide Description [Not Specified]
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0, n=8, 5 175.38  (58.47) 201.80  (59.12)
Week 8, n=7, 6 198.00  (53.85) 187.67  (85.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.917
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
8.Secondary Outcome
Title Pharmacokinetics: Cmax of Free Insulin
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Median (Standard Deviation)
Unit of Measure: pmol/L
Week 0 216  (542.4) 167  (130.4)
Week 8 274  (109.2) 186  (105.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.209
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
9.Secondary Outcome
Title Pharmacokinetics: Tmax of Free Insulin
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Median (Standard Deviation)
Unit of Measure: hours
Week 0 2.5  (0.74) 3.0  (0.98)
Week 8 2.5  (0.8) 1.8  (0.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.220
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
10.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Median (Standard Deviation)
Unit of Measure: pmol.h/L
Week 0 638.4  (1022.95) 398.9  (395.19)
Week 8 819.6  (310.41) 466.2  (266.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments [Not Specified]
Method ANCOVA
Comments With adjustment for baseline value
11.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 11 11
Median (Standard Deviation)
Unit of Measure: pmol.h/L
Week 0, n=8, 9 1441.3  (7516.22) 752.1  (4128.04)
Week 8, n=11, 11 1981.1  (1442.49) 672.8  (7156.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.534
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
12.Secondary Outcome
Title Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 11 11
Median (Standard Deviation)
Unit of Measure: hours
Week 0, n=8, 9 3.6  (17.84) 2.3  (10.93)
Week 8, n=11, 11 2.9  (3.34) 2.0  (11.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.722
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
13.Secondary Outcome
Title Pharmacokinetics: Cmax of Insulin Detemir
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Median (Standard Deviation)
Unit of Measure: pmol/L
Week 0 10700  (25149.9) 10500  (6840.2)
Week 8 12000  (23807.2) 12600  (8426.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.727
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
14.Secondary Outcome
Title Pharmacokinetics: Tmax of Insulin Detemir
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Median (Standard Deviation)
Unit of Measure: hours
Week 0 3.5  (0.93) 3.5  (0.48)
Week 8 3.5  (0.38) 3.3  (0.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.411
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
15.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Median (Standard Deviation)
Unit of Measure: pmol.h/L
Week 0 36591.2  (70709.5) 34653.4  (21243.3)
Week 8 36055.0  (73609.6) 39757.0  (23076.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.471
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
16.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 4 6
Median (Standard Deviation)
Unit of Measure: pmol.h/L
Week 0, n=4, 3 230728.2  (304790.62) 68509.6  (116350.34)
Week 8, n=3, 6 123555.7  (141207.72) 362313.5  (4287360.41)
17.Secondary Outcome
Title Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 4 6
Median (Standard Deviation)
Unit of Measure: hours
Week 0, n=4, 3 16.2  (4.12) 8.2  (6.53)
Week 8, n=3, 6 5.6  (4.2) 20.8  (249.57)
18.Secondary Outcome
Title Pharmacokinetics: Cmax of Insulin Aspart
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Median (Standard Deviation)
Unit of Measure: pmol/L
Week 0 557  (2784.2) 762  (378.3)
Week 8 662  (576.3) 601  (355.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
19.Secondary Outcome
Title Pharmacokinetics: Tmax of Insulin Aspart
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Median (Standard Deviation)
Unit of Measure: hours
Week 0 2  (0.99) 2  (0.97)
Week 8 2  (0.53) 1.5  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
20.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Median (Standard Deviation)
Unit of Measure: pmol.h/L
Week 0 1546.3  (3163.27) 1510.9  (963.37)
Week 8 2102.4  (1378.73) 1540  (894.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
21.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Median (Standard Deviation)
Unit of Measure: pmol.h/L
Week 0, n=10, 11 3008.1  (7689.04) 3006.3  (4458.12)
Week 8, n=13, 12 5674.3  (10668.8) 3019.9  (1013.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
22.Secondary Outcome
Title Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart
Hide Description The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Median (Standard Deviation)
Unit of Measure: hours
Week 0, n=10, 11 2.2  (6.75) 2  (3.09)
Week 8, n=13, 12 3.5  (41.88) 1.7  (1.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.439
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
23.Secondary Outcome
Title Weight Z Score
Hide Description Z score of weight. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: Z-score
Week 0, n=13, 12 -0.42  (0.71) 0.19  (0.69)
Week 8, n=11, 12 -0.29  (0.65) 0.26  (0.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
24.Secondary Outcome
Title Body Mass Index (BMI) Z Score
Hide Description Z score of BMI index. To estimate the growth of children, standardised mean BMI values were calculated for each month of age and for each sex
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: Z-score
Week 0, n=13, 12 -0.32  (0.63) 0.04  (0.86)
Week 8, n=11, 12 -0.07  (0.52) 0.26  (0.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mixed Injection, Separate Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.665
Comments [Not Specified]
Method ANCOVA
Comments With adjustment on baseline value
25.Secondary Outcome
Title Incidence of Hypoglycaemic Episodes - All Episodes
Hide Description Number of hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose less than 56 mg/dL (3.1 mmol/L). Classified as major, minor or symptoms only. Major if unable to treat her/himself (given the age of the study population, the definition of major hypoglycemia was to be adapted through the investigator’s judgment). Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time Frame Weeks 0-8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: episodes
351 293
26.Secondary Outcome
Title Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L
Hide Description Number of minor hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose below 3.1 mmol/L (56 mg/dL) and the child is able to treat her/himself.
Time Frame Weeks 0-8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: episodes
With symptoms 68 159
Without (w/o) symptoms 75 48
W/o info on presence of symptoms 23 6
27.Secondary Outcome
Title Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L
Hide Description Number of “symptoms only” hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose higher than or equal to 3.1 mmol/L (56 mg/dL) or no plasma glucose measurement and the child is able to treat her/himself.
Time Frame Weeks 0-8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: episodes
With symptoms 49 46
Without (w/o) symptoms 131 33
W/o information on presence of symptoms 5 1
28.Secondary Outcome
Title Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face"
Hide Description Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: percentage of subjects
Week 0 45 33
Week 8 0 23
29.Secondary Outcome
Title Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face"
Hide Description Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.
Time Frame Week 0 and week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: percentage of subjects
Week 0 27 50
Week 8 81 69
30.Secondary Outcome
Title Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face"
Hide Description Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.
Time Frame Week 0 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description:
Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: percentage of subjects
Week 0 27.3 16.7
Week 8 18.2 7.7
Time Frame Adverse events are collected during treatment period (8 weeks)
Adverse Event Reporting Description All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
 
Arm/Group Title Mixed Injection Separate Injection
Hide Arm/Group Description Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
All-Cause Mortality
Mixed Injection Separate Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mixed Injection Separate Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mixed Injection Separate Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/12 (41.67%)      9/13 (69.23%)    
Eye disorders     
Conjunctivitis allergic  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/12 (0.00%)  0 3/13 (23.08%)  3
General disorders     
Injection site reaction  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Pyrexia  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Infections and infestations     
Rhinitis  1  1/12 (8.33%)  1 2/13 (15.38%)  2
Gastroenteritis  1  1/12 (8.33%)  1 1/13 (7.69%)  1
Bronchitis  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Enterobiasis  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Nasopharyngitis  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Viral infection  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Reproductive system and breast disorders     
Gynaecomastia  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders     
Eczema  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Surgical and medical procedures     
Orthodontic procedure  1  0/12 (0.00%)  0 1/13 (7.69%)  1
Tooth extraction  1  1/12 (8.33%)  1 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Steering Committee has the right to publish the entire results of the trial. Any such scientific paper, presentation, communication, or other information concerning the investigation must be approved by the Steering Committee, and copies submitted in writing to Novo Nordisk prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
Results Point of Contact
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00542620     History of Changes
Other Study ID Numbers: NN304-1813
2006-006715-77 ( EudraCT Number )
First Submitted: October 10, 2007
First Posted: October 11, 2007
Results First Submitted: December 5, 2011
Results First Posted: January 18, 2013
Last Update Posted: November 3, 2014