Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01159600
Recruitment Status : Completed
First Posted : July 9, 2010
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Placebo identical to BI 10773 high dose
Drug: Placebo identical to BI 10773 low dose
Drug: BI 10773
Enrollment 1504
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Met: Placebo Met: Empa 10mg Met: Empa 25mg Met: Empa 25mg Open Label Met+SU: Placebo Met+SU: Empa 10mg Met+SU: Empa 25mg Met+SU: Empa 25mg Open Label
Hide Arm/Group Description A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only. Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only. Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only. Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only. A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU). Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU). Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU). Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Period Title: Overall Study
Started 207 217 214 69 225 226 218 103
Completed 186 209 196 58 201 208 199 85
Not Completed 21 8 18 11 24 18 19 18
Reason Not Completed
Not treated             0             0             1             0             0             1             2             2
Adverse Event             7             2             5             1             8             6             7             5
Lack of Efficacy             0             0             0             0             2             0             0             1
Non compliant with protocol             2             1             0             0             2             0             2             0
Lost to Follow-up             2             3             4             3             3             0             3             2
Patient refusal to continue,not due toAE             7             2             4             5             4             4             2             5
Other reason not defined above             3             0             4             2             5             7             3             3
Arm/Group Title Met: Placebo Met: Empa 10mg Met: Empa 25mg Met: Empa 25mg Open Label Met+SU: Placebo Met+SU: Empa 10mg Met+SU: Empa 25mg Met+SU: Empa 25mg Open Label Total
Hide Arm/Group Description A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only. Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only. Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only. Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only. A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU). Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU). Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU). Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU). Total of all reporting groups
Overall Number of Baseline Participants 207 217 213 69 225 225 216 101 1473
Hide Baseline Analysis Population Description
Full analysis set (FAS), which included all randomised patients treated with at least one dose of study drug with a baseline HbA1c value. Treatment assignment as randomised. Open label set which included all patients entered in the empa 25mg open-label arm.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 217 participants 213 participants 69 participants 225 participants 225 participants 216 participants 101 participants 1473 participants
56.0  (9.7) 55.5  (9.9) 55.6  (10.2) 49.8  (11.5) 56.9  (9.2) 57.0  (9.2) 57.4  (9.3) 53.4  (10.5) 55.9  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 217 participants 213 participants 69 participants 225 participants 225 participants 216 participants 101 participants 1473 participants
Female
91
  44.0%
92
  42.4%
93
  43.7%
28
  40.6%
113
  50.2%
112
  49.8%
102
  47.2%
47
  46.5%
678
  46.0%
Male
116
  56.0%
125
  57.6%
120
  56.3%
41
  59.4%
112
  49.8%
113
  50.2%
114
  52.8%
54
  53.5%
795
  54.0%
1.Primary Outcome
Title HbA1c Change From Baseline
Hide Description

Change from baseline in HbA1c after 24 weeks.

For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.

Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Full analysis set. Treatment assignment as randomised.

Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.

Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Arm/Group Title Met: Placebo Met: Empa 10mg Met: Empa 25mg Met: Empa 25mg Open Label Met+SU: Placebo Met+SU: Empa 10mg Met+SU: Empa 25mg Met+SU: Empa 25mg Open Label
Hide Arm/Group Description:
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks, in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Overall Number of Participants Analyzed 207 217 213 69 225 225 216 101
Mean (Standard Error)
Unit of Measure: percentage of HbA1c
-0.13  (0.05) -0.70  (0.05) -0.77  (0.05) -2.78  (0.21) -0.17  (0.05) -0.82  (0.05) -0.77  (0.05) -2.53  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Met: Placebo, Met: Empa 10mg
Comments Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR (renal function), geographical region and treatment as fixed effects.
Method of Estimation Estimation Parameter Mean difference
Estimated Value -0.57
Confidence Interval (2-Sided) 97.5%
-0.72 to -0.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments Difference calculated as Met: empa 10mg minus Met: placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Met: Placebo, Met: Empa 25mg
Comments Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.
Method of Estimation Estimation Parameter Mean difference
Estimated Value -0.64
Confidence Interval (2-Sided) 97.5%
-0.79 to -0.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments Difference calculated as Met: empa 25mg minus Met: placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Met+SU: Placebo, Met+SU: Empa 10mg
Comments Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.
Method of Estimation Estimation Parameter Mean difference
Estimated Value -0.64
Confidence Interval (2-Sided) 97.5%
-0.79 to -0.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Met+SU: Placebo, Met+SU: Empa 25mg
Comments Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.
Method of Estimation Estimation Parameter Mean difference
Estimated Value -0.59
Confidence Interval (2-Sided) 97.5%
-0.74 to -0.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo
2.Secondary Outcome
Title Body Weight Change From Baseline
Hide Description

Body weight change from baseline after 24 weeks.

For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.

Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Full analysis set. Treatment assignment as randomised.

Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.

Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Arm/Group Title Met: Placebo Met: Empa 10mg Met: Empa 25mg Met: Empa 25mg Open Label Met+SU: Placebo Met+SU: Empa 10mg Met+SU: Empa 25mg Met+SU: Empa 25mg Open Label
Hide Arm/Group Description:
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Overall Number of Participants Analyzed 207 217 213 69 225 225 216 101
Mean (Standard Error)
Unit of Measure: kg
-0.45  (0.17) -2.08  (0.17) -2.46  (0.17) -1.33  (0.43) -0.39  (0.15) -2.16  (0.15) -2.39  (0.16) -1.29  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Met: Placebo, Met: Empa 10mg
Comments Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects
Method of Estimation Estimation Parameter Mean difference
Estimated Value -1.63
Confidence Interval (2-Sided) 97.5%
-2.17 to -1.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments Difference calculated as Met: empa 10mg minus Met: placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Met: Placebo, Met: Empa 25mg
Comments Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects
Method of Estimation Estimation Parameter Mean difference
Estimated Value -2.01
Confidence Interval (2-Sided) 97.5%
-2.56 to -1.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments Difference calculated as Met: empa 25mg minus Met: placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Met+SU: Placebo, Met+SU: Empa 10mg
Comments Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects
Method of Estimation Estimation Parameter Mean difference
Estimated Value -1.76
Confidence Interval (2-Sided) 97.5%
-2.25 to -1.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Met+SU: Placebo, Met+SU: Empa 25mg
Comments Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects
Method of Estimation Estimation Parameter Mean difference
Estimated Value -1.99
Confidence Interval (2-Sided) 97.5%
-2.48 to -1.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo
3.Secondary Outcome
Title Mean Daily Plasma Glucose (MDG) Change From Baseline
Hide Description

Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment.

For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.

Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Full analysis set. Treatment assignment as randomised.

Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.

Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Arm/Group Title Met: Placebo Met: Empa 10mg Met: Empa 25mg Met: Empa 25mg Open Label Met+SU: Placebo Met+SU: Empa 10mg Met+SU: Empa 25mg Met+SU: Empa 25mg Open Label
Hide Arm/Group Description:
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Overall Number of Participants Analyzed 133 148 147 43 151 148 117 52
Mean (Standard Error)
Unit of Measure: mg/dL
-1.99  (1.99) -9.64  (1.89) -14.36  (1.89) -35.47  (7.34) 0.00  (1.78) -10.01  (1.80) -13.06  (2.03) -29.34  (6.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Met: Placebo, Met: Empa 10mg
Comments Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0055
Comments Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.
Method of Estimation Estimation Parameter Mean difference
Estimated Value -7.65
Confidence Interval (2-Sided) 97.5%
-13.81 to -1.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.74
Estimation Comments Difference calculated as Met: empa 10mg minus Met: placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Met: Placebo, Met: Empa 25mg
Comments Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.
Method of Estimation Estimation Parameter Mean difference
Estimated Value -12.37
Confidence Interval (2-Sided) 97.5%
-18.55 to -6.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.75
Estimation Comments Difference calculated as Met: empa 25mg minus Met: placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Met+SU: Placebo, Met+SU: Empa 10mg
Comments Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.
Method of Estimation Estimation Parameter Mean difference
Estimated Value -10.02
Confidence Interval (2-Sided) 97.5%
-15.72 to -4.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.53
Estimation Comments Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Met+SU: Placebo, Met+SU: Empa 25mg
Comments Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.
Method ANCOVA
Comments Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.
Method of Estimation Estimation Parameter Mean difference
Estimated Value -13.06
Confidence Interval (2-Sided) 97.5%
-19.15 to -6.98
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.70
Estimation Comments Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo
4.Other Pre-specified Outcome
Title Confirmed Hypoglycaemic Adverse Events
Hide Description Number of patients with confirmed hypoglycaemic events, as reported as adverse events.
Time Frame From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Hide Outcome Measure Data
Hide Analysis Population Description

Treated set, which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.

Open label set which included all patients entered into the open-label arm.

Arm/Group Title Met: Placebo Met: Empa 10mg Met: Empa 25mg Met: Empa 25mg Open Label Met+SU: Placebo Met+SU: Empa 10mg Met+SU: Empa 25mg Met+SU: Empa 25mg Open Label
Hide Arm/Group Description:
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
Overall Number of Participants Analyzed 206 217 214 69 225 224 217 101
Measure Type: Number
Unit of Measure: percentage of participants
0.5 1.8 1.4 2.9 8.4 16.1 11.5 6.9
Time Frame From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Adverse Event Reporting Description

Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.

Open label set which included all patients entered into the open-label arm

 
Arm/Group Title Met: Placebo Met: Empa 10mg Met: Empa 25mg Met: Empa 25mg Open Label Met+SU: Placebo Met+SU: Empa 10mg Met+SU: Empa 25mg Met+SU: Empa 25mg Open Label
Hide Arm/Group Description A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only. Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only. Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only. Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only. A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU). Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU). Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU). Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
All-Cause Mortality
Met: Placebo Met: Empa 10mg Met: Empa 25mg Met: Empa 25mg Open Label Met+SU: Placebo Met+SU: Empa 10mg Met+SU: Empa 25mg Met+SU: Empa 25mg Open Label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Met: Placebo Met: Empa 10mg Met: Empa 25mg Met: Empa 25mg Open Label Met+SU: Placebo Met+SU: Empa 10mg Met+SU: Empa 25mg Met+SU: Empa 25mg Open Label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/206 (3.40%)   7/217 (3.23%)   5/214 (2.34%)   1/69 (1.45%)   14/225 (6.22%)   11/224 (4.91%)   1/217 (0.46%)   5/101 (4.95%) 
Cardiac disorders                 
Angina unstable  1  0/206 (0.00%)  1/217 (0.46%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Arteriosclerosis coronary artery  1  0/206 (0.00%)  1/217 (0.46%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Cardiac failure congestive  1  1/206 (0.49%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Myocardial infarction  1  1/206 (0.49%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Acute myocardial infarction  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  1/101 (0.99%) 
Angina pectoris  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  1/101 (0.99%) 
Aortic valve stenosis  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Congenital, familial and genetic disorders                 
Hydrocele  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Phimosis  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
Endocrine disorders                 
Goitre  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Gastrointestinal disorders                 
Gastritis  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  2/224 (0.89%)  0/217 (0.00%)  0/101 (0.00%) 
Abdominal hernia  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
Duodenal ulcer  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
Faecaloma  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
General disorders                 
Non-cardiac chest pain  1  1/206 (0.49%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Chest pain  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Hepatobiliary disorders                 
Hepatitis toxic  1  1/206 (0.49%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Immune system disorders                 
Hypersensitivity  1  1/206 (0.49%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Infections and infestations                 
Anal abscess  1  1/206 (0.49%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Cellulitis  1  1/206 (0.49%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Sepsis  1  1/206 (0.49%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Herpes zoster  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  1/101 (0.99%) 
Listeria sepsis  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Pneumonia  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Pneumonia primary atypical  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Injury, poisoning and procedural complications                 
Injury  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  1/69 (1.45%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Comminuted fracture  1  0/206 (0.00%)  1/217 (0.46%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Facial bones fracture  1  0/206 (0.00%)  1/217 (0.46%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Fall  1  0/206 (0.00%)  1/217 (0.46%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
Ligament rupture  1  0/206 (0.00%)  0/217 (0.00%)  1/214 (0.47%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Tendon rupture  1  0/206 (0.00%)  0/217 (0.00%)  1/214 (0.47%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Lumbar vertebral fracture  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  1/101 (0.99%) 
Femoral neck fracture  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
Neck injury  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
Post-traumatic neck syndrome  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
Investigations                 
Blood creatinine increased  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Foot deformity  1  1/206 (0.49%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Osteoarthritis  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Breast cancer  1  0/206 (0.00%)  0/217 (0.00%)  1/214 (0.47%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Prostatic adenoma  1  0/206 (0.00%)  0/217 (0.00%)  1/214 (0.47%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Prostate cancer  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  1/101 (0.99%) 
Colon cancer  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Nervous system disorders                 
Lacunar infarction  1  0/206 (0.00%)  1/217 (0.46%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Trigeminal neuralgia  1  0/206 (0.00%)  1/217 (0.46%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Cerebrovascular accident  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  1/217 (0.46%)  0/101 (0.00%) 
Dizziness  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
Intercostal neuralgia  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Syringomyelia  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
Psychiatric disorders                 
Stress  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
Renal and urinary disorders                 
Diabetic nephropathy  1  0/206 (0.00%)  0/217 (0.00%)  1/214 (0.47%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Cystitis haemorrhagic  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  1/225 (0.44%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Reproductive system and breast disorders                 
Benign prostatic hyperplasia  1  0/206 (0.00%)  1/217 (0.46%)  0/214 (0.00%)  0/69 (0.00%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Vascular disorders                 
Peripheral arterial occlusive disease  1  0/206 (0.00%)  0/217 (0.00%)  1/214 (0.47%)  0/69 (0.00%)  0/225 (0.00%)  1/224 (0.45%)  0/217 (0.00%)  0/101 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Met: Placebo Met: Empa 10mg Met: Empa 25mg Met: Empa 25mg Open Label Met+SU: Placebo Met+SU: Empa 10mg Met+SU: Empa 25mg Met+SU: Empa 25mg Open Label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   56/206 (27.18%)   29/217 (13.36%)   38/214 (17.76%)   18/69 (26.09%)   76/225 (33.78%)   77/224 (34.38%)   67/217 (30.88%)   28/101 (27.72%) 
Gastrointestinal disorders                 
Diarrhoea  1  7/206 (3.40%)  4/217 (1.84%)  3/214 (1.40%)  4/69 (5.80%)  0/225 (0.00%)  0/224 (0.00%)  0/217 (0.00%)  0/101 (0.00%) 
Infections and infestations                 
Nasopharyngitis  1  16/206 (7.77%)  12/217 (5.53%)  15/214 (7.01%)  5/69 (7.25%)  11/225 (4.89%)  18/224 (8.04%)  13/217 (5.99%)  5/101 (4.95%) 
Urinary tract infection  1  8/206 (3.88%)  9/217 (4.15%)  9/214 (4.21%)  5/69 (7.25%)  15/225 (6.67%)  21/224 (9.38%)  15/217 (6.91%)  3/101 (2.97%) 
Upper respiratory tract infections  1  9/206 (4.37%)  2/217 (0.92%)  9/214 (4.21%)  4/69 (5.80%)  12/225 (5.33%)  7/224 (3.13%)  11/217 (5.07%)  3/101 (2.97%) 
Metabolism and nutrition disorders                 
Hypoglycaemia  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  22/225 (9.78%)  35/224 (15.63%)  28/217 (12.90%)  9/101 (8.91%) 
Hyperglycaemia  1  23/206 (11.17%)  5/217 (2.30%)  2/214 (0.93%)  2/69 (2.90%)  28/225 (12.44%)  6/224 (2.68%)  5/217 (2.30%)  8/101 (7.92%) 
Nervous system disorders                 
Dizziness  1  0/206 (0.00%)  0/217 (0.00%)  0/214 (0.00%)  0/69 (0.00%)  12/225 (5.33%)  5/224 (2.23%)  9/217 (4.15%)  2/101 (1.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.1
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01159600     History of Changes
Other Study ID Numbers: 1245.23
2009-016258-41 ( EudraCT Number: EudraCT )
First Submitted: July 8, 2010
First Posted: July 9, 2010
Results First Submitted: May 16, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014