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  
Number of Participants  
[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
  Show All Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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)  
Number of 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:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
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[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:
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12.  Secondary:   Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

13.  Secondary:   Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdf@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01289990     History of Changes
Other Study ID Numbers: 1245.31, 2010-022718-17
Study First Received: January 31, 2011
Results First Received: May 16, 2014
Last Updated: July 14, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Japan: Ministry of Health, Labor and Welfare
Mexico: Federal Commission for Sanitary Risks Protection
Philippines: Department of Health
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
Switzerland: Swissmedic
Taiwan:
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration