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Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes (SimpleMix™)

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ClinicalTrials.gov Identifier: NCT01427920
Recruitment Status : Completed
First Posted : September 2, 2011
Results First Posted : September 12, 2013
Last Update Posted : February 24, 2017
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 2
Intervention Drug: biphasic insulin aspart 30
Enrollment 348
Recruitment Details A total of 33 sites in 5 countries enrolled subjects.
Pre-assignment Details  
Arm/Group Title Subject-driven Investigator-driven
Hide Arm/Group Description The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation. The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
Period Title: Overall Study
Started 174 174
Exposed 174 173 [1]
Completed 165 157
Not Completed 9 17
Reason Not Completed
Adverse Event             1             2
Lack of Efficacy             1             0
Protocol Violation             1             3
Withdrawal Criteria             4             4
Unclassified             2             8
[1]
One subject withdrew prior to exposure to trial drug
Arm/Group Title Subject-driven Investigator-driven Total
Hide Arm/Group Description The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation. The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation. Total of all reporting groups
Overall Number of Baseline Participants 174 174 348
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 174 participants 174 participants 348 participants
58.9  (9.8) 58.0  (9.5) 58.5  (9.6)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 174 participants 348 participants
Female
83
  47.7%
87
  50.0%
170
  48.9%
Male
91
  52.3%
87
  50.0%
178
  51.1%
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 174 participants 174 participants 348 participants
81.0  (16.2) 78.0  (15.0) 79.5  (15.7)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 174 participants 174 participants 348 participants
29.7  (4.8) 29.2  (4.7) 29.4  (4.7)
Glycosylated Haemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated haemoglobin
Number Analyzed 174 participants 174 participants 348 participants
8.3  (0.9) 8.3  (0.9) 8.3  (0.9)
Fasting Plasma Glucose  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 174 participants 174 participants 348 participants
9.1  (2.7) 8.8  (2.8) 9.0  (2.7)
1.Primary Outcome
Title Change in HbA1c (Glycosylated Haemoglobin) - FAS
Hide Description Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - analysis included endpoint derived after 20 Weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.
Arm/Group Title Subject-driven Investigator-driven
Hide Arm/Group Description:
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
Overall Number of Participants Analyzed 169 166
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated haemoglobin
-0.72  (0.08) -0.97  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subject-driven, Investigator-driven
Comments FAS
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Linear
Comments Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.
Method of Estimation Estimation Parameter Estimated treatment difference, Mean
Estimated Value 0.25
Confidence Interval 95%
0.04 to 0.46
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in HbA1c (Glycosylated Haemoglobin) - PP
Hide Description Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in per protocol (PP) analysis set.
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) analysis set - analysis included subjects exposed to BIAsp 30 for more than 12 weeks without any major protocol violations. 24 subjects did not contribute to the statistical analysis after Week 20.
Arm/Group Title Subject-driven Investigator-driven
Hide Arm/Group Description:
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
Overall Number of Participants Analyzed 164 160
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated haemoglobin
-0.71  (0.08) -0.98  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subject-driven, Investigator-driven
Comments PP
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Linear
Comments Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.
Method of Estimation Estimation Parameter Estimated treatment difference, Mean
Estimated Value 0.26
Confidence Interval 95%
0.05 to 0.48
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)
Hide Description Estimated mean change from baseline in FPG after 20 Weeks of treatment
Time Frame Week 0, week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.
Arm/Group Title Subject-driven Investigator-driven
Hide Arm/Group Description:
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
Overall Number of Participants Analyzed 169 166
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.94  (0.21) -1.07  (0.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subject-driven, Investigator-driven
Comments H0: D = 0.0% against HA: D ≠ 0.0%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.659
Comments [Not Specified]
Method Regression, Linear
Comments Model includes treatment, strata and region as factors and relevant baseline FPG as covariate.
Method of Estimation Estimation Parameter Estimated treatment difference, Mean
Estimated Value 0.13
Confidence Interval 95%
-0.44 to 0.69
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes
Hide Description A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product, and no later than one day after product administration. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time Frame Week 0 to week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all subjects who received at least one dose of BIAsp 30. One subject did not contribute to data.
Arm/Group Title Subject-driven Investigator-driven
Hide Arm/Group Description:
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
Overall Number of Participants Analyzed 174 173
Measure Type: Number
Unit of Measure: episodes
638 766
5.Secondary Outcome
Title Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
Hide Description From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 10 subjects did not contribute to data.
Arm/Group Title Subject-driven Investigator-driven
Hide Arm/Group Description:
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
Overall Number of Participants Analyzed 169 169
Mean (Standard Deviation)
Unit of Measure: scores on a scale
67.2  (14.7) 70.0  (15.3)
6.Secondary Outcome
Title Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
Hide Description From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 20 subjects did not contribute to data.
Arm/Group Title Subject-driven Investigator-driven
Hide Arm/Group Description:
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
Overall Number of Participants Analyzed 165 163
Mean (Standard Deviation)
Unit of Measure: scores on a scale
71.0  (13.1) 71.8  (14.4)
7.Secondary Outcome
Title Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
Hide Description From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 17 subjects did not contribute to data.
Arm/Group Title Subject-driven Investigator-driven
Hide Arm/Group Description:
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
Overall Number of Participants Analyzed 167 164
Mean (Standard Deviation)
Unit of Measure: scores on a scale
73.9  (13.6) 74.0  (15.4)
Time Frame Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Adverse Event Reporting Description Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
 
Arm/Group Title Subject-driven Investigator-driven
Hide Arm/Group Description The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation. The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
All-Cause Mortality
Subject-driven Investigator-driven
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Subject-driven Investigator-driven
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/174 (1.15%)      3/173 (1.73%)    
Gastrointestinal disorders     
Abdominal pain  1  0/174 (0.00%)  0 1/173 (0.58%)  1
Infections and infestations     
Endophthalmitis  1  0/174 (0.00%)  0 1/173 (0.58%)  1
Pneumonia  1  0/174 (0.00%)  0 1/173 (0.58%)  1
Injury, poisoning and procedural complications     
Meniscus lesion  1  1/174 (0.57%)  1 0/173 (0.00%)  0
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/174 (0.00%)  0 1/173 (0.58%)  1
Nervous system disorders     
Lacunar infarction  1  1/174 (0.57%)  1 0/173 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Subject-driven Investigator-driven
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/174 (0.00%)      0/173 (0.00%)    
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.
Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Novo Nordisk reserves the right to prior review of such publications and to ask for delay of publication of individual site results until after the primary manuscript is accepted for publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01427920    
Other Study ID Numbers: BIASP-3878
2010-024303-27 ( EudraCT Number )
U1111-1118-4096 ( Other Identifier: WHO )
First Submitted: August 31, 2011
First Posted: September 2, 2011
Results First Submitted: July 3, 2013
Results First Posted: September 12, 2013
Last Update Posted: February 24, 2017