Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01289990
First received: January 31, 2011
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: BI 10773
Drug: Placebo
Drug: Sitagliptin 100mg

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Empagliflozin 10 mg (Drug Naive)

Patients rolled over from trial 1245.20

Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching Empagliflozin 25 mg

Empagliflozin 25 mg (Drug Naive)

Patients rolled over from trial 1245.20

Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching Empagliflozin 10 mg

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

Empagliflozin 10 mg (Pioglitazone)

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

Empagliflozin 25 mg (Pioglitazone)

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

Placebo (Pioglitazone)

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

Empagliflozin 10 mg (Metformin)

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

Empagliflozin 25 mg (Metformin)

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

Placebo (Metformin)

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

Empagliflozin 10 mg (Metformin+Sulfonylurea)

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

Empagliflozin 25 mg (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

Patients rolled over from trial 1245.23

Placebo tablets matching Empagliflozin

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Empagliflozin 25 mg


Participant Flow:   Overall Study
    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)
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 
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 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Empagliflozin 10 mg (Drug Naive)

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

Empagliflozin 25 mg (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100 mg (Drug Naive)

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

Empagliflozin 10 mg (Pioglitazone)

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

Empagliflozin 25 mg (Pioglitazone)

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

Placebo (Pioglitazone)

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

Empagliflozin 10 mg (Metformin)

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

Empagliflozin 25 mg (Metformin)

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

Placebo (Metformin)

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

Empagliflozin 10 mg (Metformin+Sulfonylurea)

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

Empagliflozin 25 mg (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

Patients rolled over from trial 1245.23

Placebo tablets matching Empagliflozin

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Empagliflozin 25 mg

Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 224   224   228   223   165   168   165   217   213   207   225   216   225   2700 
Age 
[Units: Years]
Mean (Standard Deviation)
 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) 
Gender 
[Units: Participants]
                           
Female   82   79   105   82   82   83   92   92   93   91   112   102   113   1208 
Male   142   145   123   141   83   85   73   125   120   116   113   114   112   1492 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

Measure Type Primary
Measure Title Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Measure Description Change from baseline in HbA1c after 52 weeks
Time Frame Baseline and 52 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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)


Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)

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

BI 10773 High (Metformin)

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

Placebo (Metformin)

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

BI 10773 Low (Metformin+Sulfonylurea)

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

BI 10773 High (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

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


Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 224   224   228   223   165   168   165   217   213   207   225   216   225 
Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment 
[Units: % of HbA1c]
Least Squares Mean (Standard Error)
 -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) 


Statistical Analysis 1 for Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.79
Standard Error of the mean (0.08)
95% Confidence Interval -0.94 to -0.64
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  statistical analysis at week 52
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.91
Standard Error of the mean (0.08)
95% Confidence Interval -1.06 to -0.76
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  statistical analysis at week 52
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Groups [1] Placebo (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.67
Standard Error of the mean (0.08)
95% Confidence Interval -0.82 to -0.52
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  statistical analysis at week 52
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.1245
Adjusted mean difference [4] -0.12
Standard Error of the mean (0.08)
95% Confidence Interval -0.27 to 0.03
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  statistical analysis at week 52
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0022
Adjusted mean difference [4] -0.24
Standard Error of the mean (0.08)
95% Confidence Interval -0.39 to -0.09
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  statistical analysis at week 52
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.60
Standard Error of the mean (0.10)
95% Confidence Interval -0.79 to -0.41
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Groups [1] BI 10773 High (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.68
Standard Error of the mean (0.10)
95% Confidence Interval -0.87 to -0.49
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.62
Standard Error of the mean (0.07)
95% Confidence Interval -0.75 to -0.48
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Groups [1] BI 10773 High (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.69
Standard Error of the mean (0.07)
95% Confidence Interval -0.83 to -0.55
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.74
Standard Error of the mean (0.08)
95% Confidence Interval -0.89 to -0.59
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Groups [1] BI 10773 High (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.70
Standard Error of the mean (0.08)
95% Confidence Interval -0.85 to -0.55
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.



2.  Primary:   Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

Measure Type Primary
Measure Title Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Measure Description Change from baseline in HbA1c after 76 weeks
Time Frame Baseline and 76 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)

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

BI 10773 High (Metformin)

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

Placebo (Metformin)

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

BI 10773 Low (Metformin+Sulfonylurea)

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

BI 10773 High (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

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


Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 224   224   228   223   165   168   165   217   213   207   225   216   225 
Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment 
[Units: % of HbA1c]
Least Squares Mean (Standard Deviation)
 -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) 


Statistical Analysis 1 for Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.78
Standard Error of the mean (0.08)
95% Confidence Interval -0.94 to -0.63
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.89
Standard Error of the mean (0.08)
95% Confidence Interval -1.04 to -0.73
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Groups [1] Placebo (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.66
Standard Error of the mean (0.08)
95% Confidence Interval -0.82 to -0.51
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.1310
Adjusted mean difference [4] -0.12
Standard Error of the mean (0.08)
95% Confidence Interval -0.28 to 0.04
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0050
Adjusted mean difference [4] -0.22
Standard Error of the mean (0.08)
95% Confidence Interval -0.38 to -0.07
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.59
Standard Error of the mean (0.10)
95% Confidence Interval -0.79 to -0.40
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Groups [1] BI 10773 High (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.69
Standard Error of the mean (0.10)
95% Confidence Interval -0.88 to -0.50
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.61
Standard Error of the mean (0.07)
95% Confidence Interval -0.75 to -0.46
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.73
Standard Error of the mean (0.07)
95% Confidence Interval -0.88 to -0.58
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.72
Standard Error of the mean (0.08)
95% Confidence Interval -0.87 to -0.56
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -0.69
Standard Error of the mean (0.08)
95% Confidence Interval -0.85 to -0.53
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.



3.  Secondary:   HbA1c (%) Changes From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

Measure Type Secondary
Measure Title HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Measure Description Change from baseline in HbA1c (%) after 76 weeks using MMRM approach
Time Frame Baseline and 76 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)

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

BI 10773 High (Metformin)

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

Placebo (Metformin)

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

BI 10773 Low (Metformin+Sulfonylurea)

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

BI 10773 High (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

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


Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 132   132   65   108   71   78   31   130   118   70   110   103   76 
HbA1c (%) Changes From Baseline After 76 Weeks of Treatment 
[Units: % of HbA1c]
Least Squares Mean (Standard Error)
 -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) 


Statistical Analysis 1 for HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Placebo (Drug Naive)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Adjusted mean difference [4] -0.82
Standard Error of the mean (0.11)
95% Confidence Interval -1.04 to -0.61
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Placebo (Drug Naive)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Adjusted mean difference [4] -0.90
Standard Error of the mean (0.11)
95% Confidence Interval -1.11 to -0.69
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] Mixed Models Analysis
P Value [3] 0.0322
Adjusted mean difference [4] -0.21
Standard Error of the mean (0.10)
95% Confidence Interval -0.41 to -0.02
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] Mixed Models Analysis
P Value [3] 0.0038
Adjusted mean difference [4] -0.29
Standard Error of the mean (0.10)
95% Confidence Interval -0.48 to -0.09
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Groups [1] Placebo (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Adjusted mean difference [4] -0.61
Standard Error of the mean (0.11)
95% Confidence Interval -0.83 to -0.40
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Adjusted mean difference [4] -0.62
Standard Error of the mean (0.15)
95% Confidence Interval -0.90 to -0.33
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Adjusted mean difference [4] -0.72
Standard Error of the mean (0.14)
95% Confidence Interval -1.00 to -0.44
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin) vs. Placebo (Metformin)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Adjusted mean difference [4] -0.67
Standard Error of the mean (0.10)
95% Confidence Interval -0.87 to -0.47
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin) vs. Placebo (Metformin)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Adjusted mean difference [4] -0.83
Standard Error of the mean (0.10)
95% Confidence Interval -1.04 to -0.63
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Adjusted mean difference [4] -0.80
Standard Error of the mean (0.12)
95% Confidence Interval -1.04 to -0.57
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Adjusted mean difference [4] -0.80
Standard Error of the mean (0.12)
95% Confidence Interval -1.04 to -0.56
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

Measure Type Secondary
Measure Title Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Measure Description Systolic blood pressure - change from baseline after 52 weeks of treatment
Time Frame Baseline and 52 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)

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

BI 10773 High (Metformin)

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

Placebo (Metformin)

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

BI 10773 Low (Metformin+Sulfonylurea)

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

BI 10773 High (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

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


Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 224   224   228   223   165   168   165   217   213   207   225   216   225 
Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment 
[Units: mmHg]
Least Squares Mean (Standard Error)
 -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) 


Statistical Analysis 1 for Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -4.6
Standard Error of the mean (1.1)
95% Confidence Interval -6.8 to -2.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0001
Adjusted mean difference [4] -4.2
Standard Error of the mean (1.1)
95% Confidence Interval -6.4 to -2.1
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] Placebo (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.2107
Adjusted mean difference [4] -1.4
Standard Error of the mean (1.1)
95% Confidence Interval -3.5 to 0.8
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0033
Adjusted mean difference [4] -3.3
Standard Error of the mean (1.1)
95% Confidence Interval -5.4 to -1.1
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0105
Adjusted mean difference [4] -2.8
Standard Error of the mean (1.1)
95% Confidence Interval -5.0 to -0.7
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.0543
Adjusted mean difference [4] -2.4
Standard Error of the mean (1.3)
95% Confidence Interval -4.9 to 0.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.0019
Adjusted mean difference [4] -3.9
Standard Error of the mean (1.2)
95% Confidence Interval -6.4 to -1.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] 0.0045
Adjusted mean difference [4] -3.0
Standard Error of the mean (1.0)
95% Confidence Interval -5.0 to -0.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -4.5
Standard Error of the mean (1.0)
95% Confidence Interval -6.6 to -2.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.0031
Adjusted mean difference [4] -2.9
Standard Error of the mean (1.0)
95% Confidence Interval -4.8 to -1.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.0096
Adjusted mean difference [4] -2.5
Standard Error of the mean (1.0)
95% Confidence Interval -4.4 to -0.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.



5.  Secondary:   Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

Measure Type Secondary
Measure Title Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Measure Description Systolic blood pressure - change from baseline after 76 weeks of treatment
Time Frame Baseline and 76 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)

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

BI 10773 High (Metformin)

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

Placebo (Metformin)

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

BI 10773 Low (Metformin+Sulfonylurea)

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

BI 10773 High (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

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


Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 224   224   228   223   165   168   165   217   213   207   225   216   225 
Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment 
[Units: mmHg]
Least Squares Mean (Standard Error)
 -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) 


Statistical Analysis 1 for Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0025
Adjusted mean difference [4] -3.4
Standard Error of the mean (1.1)
95% Confidence Interval -5.5 to -1.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0021
Adjusted mean difference [4] -3.4
Standard Error of the mean (1.1)
95% Confidence Interval -5.6 to -1.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] Placebo (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.7241
Adjusted mean difference [4] 0.4
Standard Error of the mean (1.1)
95% Confidence Interval -1.8 to 2.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0008
Adjusted mean difference [4] -3.7
Standard Error of the mean (1.1)
95% Confidence Interval -5.9 to -1.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0007
Adjusted mean difference [4] -3.8
Standard Error of the mean (1.1)
95% Confidence Interval -6.0 to -1.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.0987
Adjusted mean difference [4] -2.0
Standard Error of the mean (1.2)
95% Confidence Interval -4.5 to 0.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.0028
Adjusted mean difference [4] -3.7
Standard Error of the mean (1.2)
95% Confidence Interval -6.1 to -1.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -4.4
Standard Error of the mean (1.1)
95% Confidence Interval -6.6 to -2.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] 0.0008
Adjusted mean difference [4] -3.7
Standard Error of the mean (1.1)
95% Confidence Interval -5.9 to -1.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.0213
Adjusted mean difference [4] -2.2
Standard Error of the mean (1.0)
95% Confidence Interval -4.1 to -0.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.0288
Adjusted mean difference [4] -2.1
Standard Error of the mean (1.0)
95% Confidence Interval -4.1 to -0.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.



6.  Secondary:   Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

Measure Type Secondary
Measure Title Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Measure Description Diastolic blood pressure - change from baseline after 52 weeks of treatment
Time Frame Baseline and 52 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)

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

BI 10773 High (Metformin)

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

Placebo (Metformin)

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

BI 10773 Low (Metformin+Sulfonylurea)

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

BI 10773 High (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

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


Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 224   224   228   223   165   168   165   217   213   207   225   216   225 
Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment 
[Units: mmHg]
Least Squares Mean (Standard Error)
 -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) 


Statistical Analysis 1 for Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.1058
Adjusted mean difference [4] -1.1
Standard Error of the mean (0.7)
95% Confidence Interval -2.4 to 0.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0109
Adjusted mean difference [4] -1.7
Standard Error of the mean (0.7)
95% Confidence Interval -3.1 to -0.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] Placebo (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.8259
Adjusted mean difference [4] -0.2
Standard Error of the mean (0.7)
95% Confidence Interval -1.5 to 1.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.1660
Adjusted mean difference [4] -0.9
Standard Error of the mean (0.7)
95% Confidence Interval -2.3 to 0.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0212
Adjusted mean difference [4] -1.6
Standard Error of the mean (0.7)
95% Confidence Interval -2.9 to -0.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.0076
Adjusted mean difference [4] -2.0
Standard Error of the mean (0.7)
95% Confidence Interval -3.4 to -0.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.0003
Adjusted mean difference [4] -2.6
Standard Error of the mean (0.7)
95% Confidence Interval -4.1 to -1.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] 0.0170
Adjusted mean difference [4] -1.8
Standard Error of the mean (0.7)
95% Confidence Interval -3.2 to -0.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] 0.0236
Adjusted mean difference [4] -1.7
Standard Error of the mean (0.7)
95% Confidence Interval -3.1 to -0.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.2523
Adjusted mean difference [4] -0.7
Standard Error of the mean (0.6)
95% Confidence Interval -2.0 to 0.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.3494
Adjusted mean difference [4] -0.6
Standard Error of the mean (0.6)
95% Confidence Interval -1.9 to 0.7
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.



7.  Secondary:   Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

Measure Type Secondary
Measure Title Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Measure Description Diastolic blood pressure - change from baseline after 76 weeks of treatment
Time Frame Baseline and 76 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)

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

BI 10773 High (Metformin)

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

Placebo (Metformin)

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

BI 10773 Low (Metformin+Sulfonylurea)

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

BI 10773 High (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

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


Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 224   224   228   223   165   168   165   217   213   207   225   216   225 
Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment 
[Units: mmHg]
Least Squares Mean (Standard Error)
 -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) 


Statistical Analysis 1 for Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.1568
Adjusted mean difference [4] -1.0
Standard Error of the mean (0.7)
95% Confidence Interval -2.3 to 0.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.1323
Adjusted mean difference [4] -1.0
Standard Error of the mean (0.7)
95% Confidence Interval -2.4 to 0.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] Placebo (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.4327
Adjusted mean difference [4] 0.5
Standard Error of the mean (0.7)
95% Confidence Interval -0.8 to 1.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0289
Adjusted mean difference [4] -1.5
Standard Error of the mean (0.7)
95% Confidence Interval -2.8 to -0.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0231
Adjusted mean difference [4] -1.6
Standard Error of the mean (0.7)
95% Confidence Interval -2.9 to -0.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.0513
Adjusted mean difference [4] -1.5
Standard Error of the mean (0.8)
95% Confidence Interval -3.0 to 0.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.0038
Adjusted mean difference [4] -2.2
Standard Error of the mean (0.8)
95% Confidence Interval -3.7 to -0.7
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] 0.0084
Adjusted mean difference [4] -2.0
Standard Error of the mean (0.7)
95% Confidence Interval -3.4 to -0.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] 0.0677
Adjusted mean difference [4] -1.4
Standard Error of the mean (0.7)
95% Confidence Interval -2.8 to 0.1
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.0814
Adjusted mean difference [4] -1.1
Standard Error of the mean (0.7)
95% Confidence Interval -2.4 to 0.1
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.1785
Adjusted mean difference [4] -0.9
Standard Error of the mean (0.7)
95% Confidence Interval -2.2 to 0.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.



8.  Secondary:   Body Weight (kg) Change From Baseline After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

Measure Type Secondary
Measure Title Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Measure Description Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment
Time Frame Baseline and 52 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)

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

BI 10773 High (Metformin)

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

Placebo (Metformin)

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

BI 10773 Low (Metformin+Sulfonylurea)

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

BI 10773 High (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

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


Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 224   224   228   223   165   168   165   217   213   207   225   216   225 
Body Weight (kg) Change From Baseline After 52 Weeks of Treatment 
[Units: Kg]
Least Squares Mean (Standard Error)
 -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) 


Statistical Analysis 1 for Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.22
Standard Error of the mean (0.27)
95% Confidence Interval -2.75 to -1.69
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.14
Standard Error of the mean (0.27)
95% Confidence Interval -2.66 to -1.61
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Groups [1] Placebo (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0223
Adjusted mean difference [4] 0.62
Standard Error of the mean (0.27)
95% Confidence Interval 0.09 to 1.14
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.84
Standard Error of the mean (0.27)
95% Confidence Interval -3.37 to -2.31
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.75
Standard Error of the mean (0.27)
95% Confidence Interval -3.28 to -2.22
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.09
Standard Error of the mean (0.34)
95% Confidence Interval -2.76 to -1.41
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -1.99
Standard Error of the mean (0.34)
95% Confidence Interval -2.66 to -1.32
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -1.73
Standard Error of the mean (0.28)
95% Confidence Interval -2.27 to -1.19
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.30
Standard Error of the mean (0.28)
95% Confidence Interval -2.85 to -1.76
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -1.97
Standard Error of the mean (0.26)
95% Confidence Interval -2.48 to -1.47
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.01
Standard Error of the mean (0.26)
95% Confidence Interval -2.52 to -1.50
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.



9.  Secondary:   Body Weight (kg) Change From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

Measure Type Secondary
Measure Title Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Measure Description Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment
Time Frame Baseline and 76 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)

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

BI 10773 High (Metformin)

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

Placebo (Metformin)

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

BI 10773 Low (Metformin+Sulfonylurea)

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

BI 10773 High (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

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


Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 224   224   228   223   165   168   165   217   213   207   225   216   225 
Body Weight (kg) Change From Baseline After 76 Weeks of Treatment 
[Units: Kg]
Least Squares Mean (Standard Error)
 -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) 


Statistical Analysis 1 for Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -1.81
Standard Error of the mean (0.28)
95% Confidence Interval -2.35 to -1.26
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.02
Standard Error of the mean (0.28)
95% Confidence Interval -2.56 to -1.48
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Groups [1] Placebo (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0546
Adjusted mean difference [4] 0.54
Standard Error of the mean (0.28)
95% Confidence Interval -0.01 to 1.08
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.34
Standard Error of the mean (0.28)
95% Confidence Interval -2.89 to -1.80
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.56
Standard Error of the mean (0.28)
95% Confidence Interval -3.10 to -2.01
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -1.97
Standard Error of the mean (0.37)
95% Confidence Interval -2.69 to -1.24
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -1.71
Standard Error of the mean (0.37)
95% Confidence Interval -2.43 to -0.99
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -1.93
Standard Error of the mean (0.30)
95% Confidence Interval -2.52 to -1.34
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.19
Standard Error of the mean (0.30)
95% Confidence Interval -2.79 to -1.60
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -1.81
Standard Error of the mean (0.27)
95% Confidence Interval -2.34 to -1.27
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -1.64
Standard Error of the mean (0.27)
95% Confidence Interval -2.18 to -1.11
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.



10.  Secondary:   Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

Measure Type Secondary
Measure Title Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Measure Description Waist circumference (cm) - change from baseline after 52 weeks of treatment
Time Frame Baseline and 52 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF

Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)

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

BI 10773 High (Metformin)

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

Placebo (Metformin)

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

BI 10773 Low (Metformin+Sulfonylurea)

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

BI 10773 High (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

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


Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 223   224   228   221   163   167   165   216   213   207   222   215   219 
Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment 
[Units: Cm]
Least Squares Mean (Standard Error)
 -2.0  (0.4)   -1.7  (0.4)   0.1  (0.4)   0.4  (0.4)   -1.5  (0.4)   -1.1  (0.4)   -0.1  (0.4)   -1.5  (0.3)   -2.0  (0.3)   -0.4  (0.3)   -1.5  (0.3)   -1.5  (0.3)   -0.2  (0.3) 


Statistical Analysis 1 for Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0001
Adjusted mean difference [4] -2.1
Standard Error of the mean (0.5)
95% Confidence Interval -3.1 to -1.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0015
Adjusted mean difference [4] -1.7
Standard Error of the mean (0.5)
95% Confidence Interval -2.8 to -0.7
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Groups [1] Placebo (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.5052
Adjusted mean difference [4] 0.4
Standard Error of the mean (0.5)
95% Confidence Interval -0.7 to 1.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -2.4
Standard Error of the mean (0.5)
95% Confidence Interval -3.5 to -1.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0001
Adjusted mean difference [4] -2.1
Standard Error of the mean (0.5)
95% Confidence Interval -3.1 to -1.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.0064
Adjusted mean difference [4] -1.5
Standard Error of the mean (0.5)
95% Confidence Interval -2.6 to -0.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.0642
Adjusted mean difference [4] -1.0
Standard Error of the mean (0.5)
95% Confidence Interval -2.1 to 0.1
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] 0.0053
Adjusted mean difference [4] -1.0
Standard Error of the mean (0.4)
95% Confidence Interval -1.8 to -0.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -1.6
Standard Error of the mean (0.4)
95% Confidence Interval -2.3 to -0.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.0010
Adjusted mean difference [4] -1.3
Standard Error of the mean (0.4)
95% Confidence Interval -2.1 to -0.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Groups [1] BI 10773 High (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.0015
Adjusted mean difference [4] -1.3
Standard Error of the mean (0.4)
95% Confidence Interval -2.1 to -0.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.



11.  Secondary:   Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

Measure Type Secondary
Measure Title Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Measure Description Waist circumference (cm) - change from baseline after 76 weeks of treatment
Time Frame Baseline and 76 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF

Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)

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

BI 10773 High (Metformin)

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

Placebo (Metformin)

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

BI 10773 Low (Metformin+Sulfonylurea)

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

BI 10773 High (Metformin+Sulfonylurea)

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

Placebo (Metformin+Sulfonylurea)

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


Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 223   224   228   221   163   167   165   216   213   207   222   215   219 
Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment 
[Units: Cm]
Least Squares Mean (Standard Error)
 -1.5  (0.4)   -1.6  (0.4)   0.1  (0.4)   0.5  (0.4)   -1.4  (0.4)   -0.9  (0.4)   0.0  (0.4)   -1.8  (0.3)   -1.3  (0.3)   -0.2  (0.3)   -1.6  (0.3)   -1.4  (0.3)   -0.3  (0.3) 


Statistical Analysis 1 for Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0028
Adjusted mean difference [4] -1.6
Standard Error of the mean (0.5)
95% Confidence Interval -2.7 to -0.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Placebo (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0019
Adjusted mean difference [4] -1.7
Standard Error of the mean (0.5)
95% Confidence Interval -2.8 to -0.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Groups [1] Placebo (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.5044
Adjusted mean difference [4] 0.4
Standard Error of the mean (0.6)
95% Confidence Interval -0.7 to 1.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0003
Adjusted mean difference [4] -2.0
Standard Error of the mean (0.6)
95% Confidence Interval -3.1 to -0.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Drug Naive) vs. Sitagliptin 100mg (Drug Naive)
Method [2] ANCOVA
P Value [3] 0.0002
Adjusted mean difference [4] -2.1
Standard Error of the mean (0.6)
95% Confidence Interval -3.2 to -1.0
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.0109
Adjusted mean difference [4] -1.4
Standard Error of the mean (0.6)
95% Confidence Interval -2.5 to -0.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Pioglitazone) vs. Placebo (Pioglitazone)
Method [2] ANCOVA
P Value [3] 0.1238
Adjusted mean difference [4] -0.9
Standard Error of the mean (0.6)
95% Confidence Interval -1.9 to 0.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] <0.0001
Adjusted mean difference [4] -1.6
Standard Error of the mean (0.4)
95% Confidence Interval -2.4 to -0.8
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin) vs. Placebo (Metformin)
Method [2] ANCOVA
P Value [3] 0.0076
Adjusted mean difference [4] -1.1
Standard Error of the mean (0.4)
95% Confidence Interval -1.9 to -0.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 Low (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.0049
Adjusted mean difference [4] -1.2
Standard Error of the mean (0.4)
95% Confidence Interval -2.1 to -0.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Groups [1] BI 10773 High (Metformin+Sulfonylurea) vs. Placebo (Metformin+Sulfonylurea)
Method [2] ANCOVA
P Value [3] 0.0178
Adjusted mean difference [4] -1.0
Standard Error of the mean (0.4)
95% Confidence Interval -1.9 to -0.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.
[4] Other relevant estimation information:
  No text entered.



12.  Secondary:   Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

Measure Type Secondary
Measure Title Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment
Measure Description Fasting plasma glucose - change from baseline after 52 weeks of treatment
Time Frame Baseline and 52 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF

Reporting Groups
  Description
BI 10773 Low (Drug Naive)

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

BI 10773 High (Drug Naive)

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

Placebo (Drug Naive)

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

Sitagliptin 100mg (Drug Naive)

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

BI 10773 Low (Pioglitazone)

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

BI 10773 High (Pioglitazone)

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

Placebo (Pioglitazone)

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

BI 10773 Low (Metformin)