ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01289990
Recruitment Status : Completed
First Posted : February 4, 2011
Results First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: BI 10773
Drug: Placebo
Drug: Sitagliptin 100mg
Enrollment 2705

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Empagliflozin 10 mg (Drug Naive) Empagliflozin 25 mg (Drug Naive) Placebo (Drug Naive) Sitagliptin 100mg (Drug Naive) Empagliflozin 10 mg (Pioglitazone) Empagliflozin 25 mg (Pioglitazone) Placebo (Pioglitazone) Empagliflozin 10 mg (Metformin) Empagliflozin 25 mg (Metformin) Placebo (Metformin) Empagliflozin 10 mg (Metformin+Sulfonylurea) Empagliflozin 25 mg (Metformin+Sulfonylurea) Placebo (Metformin+Sulfonylurea)
Hide Arm/Group Description

Patients rolled over from trial 1245.20

Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.20

Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching Empagliflozin 10 mg

Patients rolled over from trial 1245.20

Placebo tablets matching Empagliflozin / Sitagliptin once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching Empagliflozin 25 mg

Placebo: Placebo matching Empagliflozin 10 mg

Sitagliptin 100mg: Sitagliptin once daily

Patients rolled over from trial 1245.19

Empagliflozin 10 mg tablets once daily

Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.19

Empagliflozin 25 mg tablets once daily

Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Empagliflozin 10 mg

Patients rolled over from trial 1245.19

Placebo tablets matching Empagliflozin once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.23

Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Empagliflozin 25 mg

Empagliflozin 10 mg: Empagliflozin 10 mg once daily

Patients rolled over from trial 1245.23

Empagliflozin 25 mg tablets once daily

Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Empagliflozin 10 mg

Patients rolled over from trial 1245.23

Placebo tablets matching Empagliflozin once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.23

Empagliflozin 10 mg tablets once daily

Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.23

Empagliflozin 25 mg tablets once daily

Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Empagliflozin 10 mg

Patients rolled over from trial 1245.23

Placebo tablets matching Empagliflozin

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Empagliflozin 25 mg

Period Title: Overall Study
Started 224 224 228 223 165 168 166 217 214 207 226 218 225
Completed 147 143 119 136 93 94 78 162 139 121 150 150 127
Not Completed 77 81 109 87 72 74 88 55 75 86 76 68 98
Reason Not Completed
Death             0             0             0             1             2             1             0             0             0             0             0             1             0
Lost to Follow-up             3             2             5             5             3             4             2             2             1             4             2             1             2
Withdrawal by Subject             15             14             12             13             8             7             13             9             12             13             11             13             16
discontinued in preceding trial             18             20             41             17             11             12             18             8             17             21             17             17             24
did not continue in extension             41             45             51             51             48             50             54             36             44             48             45             34             56
Not treated             0             0             0             0             0             0             1             0             1             0             1             2             0
Arm/Group Title Empagliflozin 10 mg (Drug Naive) Empagliflozin 25 mg (Drug Naive) Placebo (Drug Naive) Sitagliptin 100 mg (Drug Naive) Empagliflozin 10 mg (Pioglitazone) Empagliflozin 25 mg (Pioglitazone) Placebo (Pioglitazone) Empagliflozin 10 mg (Metformin) Empagliflozin 25 mg (Metformin) Placebo (Metformin) Empagliflozin 10 mg (Metformin+Sulfonylurea) Empagliflozin 25 mg (Metformin+Sulfonylurea) Placebo (Metformin+Sulfonylurea) Total
Hide Arm/Group Description

Patients rolled over from trial 1245.20

Empagliflozin 10 mg tablets once daily

Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.20

Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Sitagliptin

Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Empagliflozin 10 mg

Patients rolled over from trial 1245.20

Placebo tablets matching Empagliflozin / Sitagliptin once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching Empagliflozin 25 mg

Placebo: Placebo matching Empagliflozin 10 mg

Sitagliptin 100 mg: Sitagliptin once daily

Patients rolled over from trial 1245.19

Empagliflozin 10 mg tablets once daily

Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.19

Empagliflozin 25 mg tablets once daily

Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Empagliflozin 10 mg

Patients rolled over from trial 1245.19

Placebo tablets matching Empagliflozin once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.23

Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Empagliflozin 25 mg

Empagliflozin 10 mg: Empagliflozin 10 mg once daily

Patients rolled over from trial 1245.23

Empagliflozin 25 mg tablets once daily

Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Empagliflozin 10 mg

Patients rolled over from trial 1245.23

Placebo tablets matching Empagliflozin once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.23

Empagliflozin 10 mg tablets once daily

Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Empagliflozin 25 mg

Patients rolled over from trial 1245.23

Empagliflozin 25 mg tablets once daily

Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Empagliflozin 10 mg

Patients rolled over from trial 1245.23

Placebo tablets matching Empagliflozin

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Empagliflozin 25 mg

Total of all reporting groups
Overall Number of Baseline Participants 224 224 228 223 165 168 165 217 213 207 225 216 225 2700
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 224 participants 224 participants 228 participants 223 participants 165 participants 168 participants 165 participants 217 participants 213 participants 207 participants 225 participants 216 participants 225 participants 2700 participants
56.2  (11.6) 53.8  (11.6) 54.9  (10.9) 55.1  (9.9) 54.7  (9.9) 54.2  (8.9) 54.6  (10.5) 55.5  (9.9) 55.6  (10.2) 56.0  (9.7) 57.0  (9.2) 57.4  (9.3) 56.9  (9.2) 55.6  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants 224 participants 228 participants 223 participants 165 participants 168 participants 165 participants 217 participants 213 participants 207 participants 225 participants 216 participants 225 participants 2700 participants
Female
82
  36.6%
79
  35.3%
105
  46.1%
82
  36.8%
82
  49.7%
83
  49.4%
92
  55.8%
92
  42.4%
93
  43.7%
91
  44.0%
112
  49.8%
102
  47.2%
113
  50.2%
1208
  44.7%
Male
142
  63.4%
145
  64.7%
123
  53.9%
141
  63.2%
83
  50.3%
85
  50.6%
73
  44.2%
125
  57.6%
120
  56.3%
116
  56.0%
113
  50.2%
114
  52.8%
112
  49.8%
1492
  55.3%
1.Primary Outcome
Title Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Hide Description Change from baseline in HbA1c after 52 weeks
Time Frame Baseline and 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial.

(LOCF:Last observation carried forward)

Arm/Group Title BI 10773 Low (Drug Naive) BI 10773 High (Drug Naive) Placebo (Drug Naive) Sitagliptin 100mg (Drug Naive) BI 10773 Low (Pioglitazone) BI 10773 High (Pioglitazone) Placebo (Pioglitazone) BI 10773 Low (Metformin) BI 10773 High (Metformin) Placebo (Metformin) BI 10773 Low (Metformin+Sulfonylurea) BI 10773 High (Metformin+Sulfonylurea) Placebo (Metformin+Sulfonylurea)
Hide Arm/Group Description:

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.20

Placebo tablets matching BI 10773 / Sitagliptin once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching BI 10773 high dose

Placebo: Placebo matching BI 10773 low dose

Sitagliptin 100mg: Sitagliptin once daily

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.19

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

BI 10773: BI 10773 tablets once daily

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Overall Number of Participants Analyzed 224 224 228 223 165 168 165 217 213 207 225 216 225
Least Squares Mean (Standard Error)
Unit of Measure: % of HbA1c
-0.70  (0.05) -0.82  (0.05) 0.09  (0.05) -0.58  (0.05) -0.63  (0.07) -0.71  (0.07) -0.03  (0.07) -0.69  (0.05) -0.76  (0.05) -0.07  (0.05) -0.78  (0.05) -0.74  (0.05) -0.04  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Placebo (Drug Naive)
Comments statistical analysis at week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.79
Confidence Interval (2-Sided) 95%
-0.94 to -0.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Placebo (Drug Naive)
Comments statistical analysis at week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-1.06 to -0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments statistical analysis at week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-0.82 to -0.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments statistical analysis at week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1245
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.27 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments statistical analysis at week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.39 to -0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-0.79 to -0.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-0.87 to -0.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-0.75 to -0.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-0.83 to -0.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.74
Confidence Interval (2-Sided) 95%
-0.89 to -0.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-0.85 to -0.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
2.Primary Outcome
Title Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Hide Description Change from baseline in HbA1c after 76 weeks
Time Frame Baseline and 76 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (LOCF)
Arm/Group Title BI 10773 Low (Drug Naive) BI 10773 High (Drug Naive) Placebo (Drug Naive) Sitagliptin 100mg (Drug Naive) BI 10773 Low (Pioglitazone) BI 10773 High (Pioglitazone) Placebo (Pioglitazone) BI 10773 Low (Metformin) BI 10773 High (Metformin) Placebo (Metformin) BI 10773 Low (Metformin+Sulfonylurea) BI 10773 High (Metformin+Sulfonylurea) Placebo (Metformin+Sulfonylurea)
Hide Arm/Group Description:

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.20

Placebo tablets matching BI 10773 / Sitagliptin once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching BI 10773 high dose

Placebo: Placebo matching BI 10773 low dose

Sitagliptin 100mg: Sitagliptin once daily

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.19

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

BI 10773: BI 10773 tablets once daily

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Overall Number of Participants Analyzed 224 224 228 223 165 168 165 217 213 207 225 216 225
Least Squares Mean (Standard Deviation)
Unit of Measure: % of HbA1c
-0.65  (0.06) -0.76  (0.06) 0.13  (0.06) -0.53  (0.06) -0.61  (0.07) -0.70  (0.07) -0.01  (0.07) -0.62  (0.05) -0.74  (0.05) -0.01  (0.05) -0.74  (0.06) -0.72  (0.06) -0.03  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.78
Confidence Interval (2-Sided) 95%
-0.94 to -0.63
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.89
Confidence Interval (2-Sided) 95%
-1.04 to -0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-0.82 to -0.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1310
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.28 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0050
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.38 to -0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-0.79 to -0.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-0.88 to -0.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-0.75 to -0.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-0.88 to -0.58
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-0.87 to -0.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-0.85 to -0.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
3.Secondary Outcome
Title HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Hide Description Change from baseline in HbA1c (%) after 76 weeks using MMRM approach
Time Frame Baseline and 76 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (OC: Observed cases)
Arm/Group Title BI 10773 Low (Drug Naive) BI 10773 High (Drug Naive) Placebo (Drug Naive) Sitagliptin 100mg (Drug Naive) BI 10773 Low (Pioglitazone) BI 10773 High (Pioglitazone) Placebo (Pioglitazone) BI 10773 Low (Metformin) BI 10773 High (Metformin) Placebo (Metformin) BI 10773 Low (Metformin+Sulfonylurea) BI 10773 High (Metformin+Sulfonylurea) Placebo (Metformin+Sulfonylurea)
Hide Arm/Group Description:

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.20

Placebo tablets matching BI 10773 / Sitagliptin once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching BI 10773 high dose

Placebo: Placebo matching BI 10773 low dose

Sitagliptin 100mg: Sitagliptin once daily

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.19

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

BI 10773: BI 10773 tablets once daily

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Overall Number of Participants Analyzed 132 132 65 108 71 78 31 130 118 70 110 103 76
Least Squares Mean (Standard Error)
Unit of Measure: % of HbA1c
-0.70  (0.07) -0.77  (0.07) 0.13  (0.08) -0.48  (0.07) -0.67  (0.09) -0.77  (0.08) -0.05  (0.12) -0.60  (0.06) -0.76  (0.07) 0.07  (0.08) -0.75  (0.08) -0.75  (0.08) 0.06  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.82
Confidence Interval (2-Sided) 95%
-1.04 to -0.61
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-1.11 to -0.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0322
Comments Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.41 to -0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.48 to -0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-0.83 to -0.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-0.90 to -0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-1.00 to -0.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-0.87 to -0.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-1.04 to -0.63
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-1.04 to -0.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-1.04 to -0.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Hide Description Systolic blood pressure - change from baseline after 52 weeks of treatment
Time Frame Baseline and 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial. (LOCF)
Arm/Group Title BI 10773 Low (Drug Naive) BI 10773 High (Drug Naive) Placebo (Drug Naive) Sitagliptin 100mg (Drug Naive) BI 10773 Low (Pioglitazone) BI 10773 High (Pioglitazone) Placebo (Pioglitazone) BI 10773 Low (Metformin) BI 10773 High (Metformin) Placebo (Metformin) BI 10773 Low (Metformin+Sulfonylurea) BI 10773 High (Metformin+Sulfonylurea) Placebo (Metformin+Sulfonylurea)
Hide Arm/Group Description:

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.20

Placebo tablets matching BI 10773 / Sitagliptin once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching BI 10773 high dose

Placebo: Placebo matching BI 10773 low dose

Sitagliptin 100mg: Sitagliptin once daily

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.19

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

BI 10773: BI 10773 tablets once daily

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Overall Number of Participants Analyzed 224 224 228 223 165 168 165 217 213 207 225 216 225
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-4.9  (0.8) -4.5  (0.8) -1.6  (0.8) -0.2  (0.8) -1.8  (0.9) -3.3  (0.9) 0.6  (0.9) -3.6  (0.7) -5.2  (0.7) -0.7  (0.7) -3.1  (0.7) -2.7  (0.7) -0.2  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -4.6
Confidence Interval (2-Sided) 95%
-6.8 to -2.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-6.4 to -2.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2107
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-3.5 to 0.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.3
Confidence Interval (2-Sided) 95%
-5.4 to -1.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0105
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-5.0 to -0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0543
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-4.9 to 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-6.4 to -1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0045
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-5.0 to -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -4.5
Confidence Interval (2-Sided) 95%
-6.6 to -2.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-4.8 to -1.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0096
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-4.4 to -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Hide Description Systolic blood pressure - change from baseline after 76 weeks of treatment
Time Frame Baseline and 76 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial -LOCF
Arm/Group Title BI 10773 Low (Drug Naive) BI 10773 High (Drug Naive) Placebo (Drug Naive) Sitagliptin 100mg (Drug Naive) BI 10773 Low (Pioglitazone) BI 10773 High (Pioglitazone) Placebo (Pioglitazone) BI 10773 Low (Metformin) BI 10773 High (Metformin) Placebo (Metformin) BI 10773 Low (Metformin+Sulfonylurea) BI 10773 High (Metformin+Sulfonylurea) Placebo (Metformin+Sulfonylurea)
Hide Arm/Group Description:

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.20

Placebo tablets matching BI 10773 / Sitagliptin once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching BI 10773 high dose

Placebo: Placebo matching BI 10773 low dose

Sitagliptin 100mg: Sitagliptin once daily

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.19

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

BI 10773: BI 10773 tablets once daily

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Overall Number of Participants Analyzed 224 224 228 223 165 168 165 217 213 207 225 216 225
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-4.1  (0.8) -4.2  (0.8) -0.7  (0.8) -0.3  (0.8) -1.7  (0.9) -3.4  (0.9) 0.3  (0.9) -5.2  (0.8) -4.5  (0.8) -0.8  (0.8) -3.8  (0.7) -3.7  (0.7) -1.6  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0025
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-5.5 to -1.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-5.6 to -1.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7241
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.8 to 2.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-5.9 to -1.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-6.0 to -1.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0987
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-4.5 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0028
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-6.1 to -1.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -4.4
Confidence Interval (2-Sided) 95%
-6.6 to -2.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-5.9 to -1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0213
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-4.1 to -0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0288
Comments Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-4.1 to -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Hide Description Diastolic blood pressure - change from baseline after 52 weeks of treatment
Time Frame Baseline and 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF
Arm/Group Title BI 10773 Low (Drug Naive) BI 10773 High (Drug Naive) Placebo (Drug Naive) Sitagliptin 100mg (Drug Naive) BI 10773 Low (Pioglitazone) BI 10773 High (Pioglitazone) Placebo (Pioglitazone) BI 10773 Low (Metformin) BI 10773 High (Metformin) Placebo (Metformin) BI 10773 Low (Metformin+Sulfonylurea) BI 10773 High (Metformin+Sulfonylurea) Placebo (Metformin+Sulfonylurea)
Hide Arm/Group Description:

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.20

Placebo tablets matching BI 10773 / Sitagliptin once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching BI 10773 high dose

Placebo: Placebo matching BI 10773 low dose

Sitagliptin 100mg: Sitagliptin once daily

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.19

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

BI 10773: BI 10773 tablets once daily

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Overall Number of Participants Analyzed 224 224 228 223 165 168 165 217 213 207 225 216 225
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-1.3  (0.5) -1.9  (0.5) -0.2  (0.5) -0.3  (0.5) -1.6  (0.5) -2.2  (0.5) 0.4  (0.5) -2.2  (0.5) -2.1  (0.5) -0.4  (0.5) -1.7  (0.5) -1.6  (0.5) -1.0  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1058
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.4 to 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0109
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-3.1 to -0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8259
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.5 to 1.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1660
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.3 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0212
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.9 to -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0076
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-3.4 to -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-4.1 to -1.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0170
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-3.2 to -0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0236
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-3.1 to -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2523
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-2.0 to 0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3494
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.9 to 0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Hide Description Diastolic blood pressure - change from baseline after 76 weeks of treatment
Time Frame Baseline and 76 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF
Arm/Group Title BI 10773 Low (Drug Naive) BI 10773 High (Drug Naive) Placebo (Drug Naive) Sitagliptin 100mg (Drug Naive) BI 10773 Low (Pioglitazone) BI 10773 High (Pioglitazone) Placebo (Pioglitazone) BI 10773 Low (Metformin) BI 10773 High (Metformin) Placebo (Metformin) BI 10773 Low (Metformin+Sulfonylurea) BI 10773 High (Metformin+Sulfonylurea) Placebo (Metformin+Sulfonylurea)
Hide Arm/Group Description:

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.20

Placebo tablets matching BI 10773 / Sitagliptin once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching BI 10773 high dose

Placebo: Placebo matching BI 10773 low dose

Sitagliptin 100mg: Sitagliptin once daily

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.19

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

BI 10773: BI 10773 tablets once daily

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Overall Number of Participants Analyzed 224 224 228 223 165 168 165 217 213 207 225 216 225
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-1.6  (0.5) -1.6  (0.5) -0.6  (0.5) -0.1  (0.5) -1.3  (0.5) -2.0  (0.5) 0.2  (0.5) -2.5  (0.5) -1.9  (0.5) -0.5  (0.5) -2.6  (0.5) -2.3  (0.5) -1.4  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1568
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.3 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1323
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.4 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4327
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.8 to 1.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0289
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-2.8 to -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0231
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.9 to -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0513
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-3.0 to 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-3.7 to -0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0084
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-3.4 to -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0677
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.8 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0814
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.4 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1785
Comments Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.2 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Hide Description Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment
Time Frame Baseline and 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial. - LOCF
Arm/Group Title BI 10773 Low (Drug Naive) BI 10773 High (Drug Naive) Placebo (Drug Naive) Sitagliptin 100mg (Drug Naive) BI 10773 Low (Pioglitazone) BI 10773 High (Pioglitazone) Placebo (Pioglitazone) BI 10773 Low (Metformin) BI 10773 High (Metformin) Placebo (Metformin) BI 10773 Low (Metformin+Sulfonylurea) BI 10773 High (Metformin+Sulfonylurea) Placebo (Metformin+Sulfonylurea)
Hide Arm/Group Description:

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.20

Placebo tablets matching BI 10773 / Sitagliptin once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching BI 10773 high dose

Placebo: Placebo matching BI 10773 low dose

Sitagliptin 100mg: Sitagliptin once daily

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.19

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

BI 10773: BI 10773 tablets once daily

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Overall Number of Participants Analyzed 224 224 228 223 165 168 165 217 213 207 225 216 225
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.70  (0.19) -2.61  (0.19) -0.48  (0.19) 0.14  (0.19) -1.50  (0.24) -1.40  (0.24) 0.59  (0.24) -2.27  (0.19) -2.84  (0.19) -0.54  (0.20) -2.28  (0.18) -2.32  (0.19) -0.31  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.22
Confidence Interval (2-Sided) 95%
-2.75 to -1.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.14
Confidence Interval (2-Sided) 95%
-2.66 to -1.61
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0223
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.09 to 1.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.84
Confidence Interval (2-Sided) 95%
-3.37 to -2.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.75
Confidence Interval (2-Sided) 95%
-3.28 to -2.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.09
Confidence Interval (2-Sided) 95%
-2.76 to -1.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.99
Confidence Interval (2-Sided) 95%
-2.66 to -1.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.73
Confidence Interval (2-Sided) 95%
-2.27 to -1.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.30
Confidence Interval (2-Sided) 95%
-2.85 to -1.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.97
Confidence Interval (2-Sided) 95%
-2.48 to -1.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Metformin+Sulfonylurea), Placebo (Metformin+Sulfonylurea)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.01
Confidence Interval (2-Sided) 95%
-2.52 to -1.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.26
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Hide Description Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment
Time Frame Baseline and 76 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial -LOCF
Arm/Group Title BI 10773 Low (Drug Naive) BI 10773 High (Drug Naive) Placebo (Drug Naive) Sitagliptin 100mg (Drug Naive) BI 10773 Low (Pioglitazone) BI 10773 High (Pioglitazone) Placebo (Pioglitazone) BI 10773 Low (Metformin) BI 10773 High (Metformin) Placebo (Metformin) BI 10773 Low (Metformin+Sulfonylurea) BI 10773 High (Metformin+Sulfonylurea) Placebo (Metformin+Sulfonylurea)
Hide Arm/Group Description:

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

BI 10773 tablets once daily

Placebo: Placebo matching Sitagliptin

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.20

Placebo tablets matching BI 10773 / Sitagliptin once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching BI 10773 high dose

Placebo: Placebo matching BI 10773 low dose

Sitagliptin 100mg: Sitagliptin once daily

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.19

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.19

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

BI 10773: BI 10773 tablets once daily

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773 once daily

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 high dose

Patients rolled over from trial 1245.23

BI 10773 tablets once daily

BI 10773: BI 10773 tablets once daily

Placebo: Placebo matching BI 10773 low dose

Patients rolled over from trial 1245.23

Placebo tablets matching BI 10773

Placebo: Placebo matching BI 10773 low dose

Placebo: Placebo matching BI 10773 high dose

Overall Number of Participants Analyzed 224 224 228 223 165 168 165 217 213 207 225 216 225
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.24  (0.20) -2.45  (0.20) -0.43  (0.20) 0.10  (0.20) -1.47  (0.26) -1.21  (0.26) 0.50  (0.26) -2.39  (0.21) -2.65  (0.22) -0.46  (0.22) -2.44  (0.19) -2.28  (0.20) -0.63  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.81
Confidence Interval (2-Sided) 95%
-2.35 to -1.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Placebo (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.02
Confidence Interval (2-Sided) 95%
-2.56 to -1.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0546
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
-0.01 to 1.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.34
Confidence Interval (2-Sided) 95%
-2.89 to -1.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Drug Naive), Sitagliptin 100mg (Drug Naive)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.56
Confidence Interval (2-Sided) 95%
-3.10 to -2.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.97
Confidence Interval (2-Sided) 95%
-2.69 to -1.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection BI 10773 High (Pioglitazone), Placebo (Pioglitazone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.71
Confidence Interval (2-Sided) 95%
-2.43 to -0.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection BI 10773 Low (Metformin), Placebo (Metformin)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.93
Confidence Interval (2-Sided) 95%
-2.52 to -1.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments