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BI 10773 add-on to Metformin 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: NCT00749190
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: BI 10773
Drug: placebo
Drug: sitagliptin
Enrollment 495
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Hide Arm/Group Description Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily. Patients receive 1 mg Empagliflozin in tablets once daily. Patients receive 5 mg Empagliflozin in tablets once daily. Patients receive 10 mg Empagliflozin in tablets once daily. Patients receive 25 mg Empagliflozin in tablets once daily. Patients receive 50 mg Empagliflozin in tablets once daily. Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
Period Title: Overall Study
Started 71 71 71 71 70 70 71
Completed 66 66 70 66 70 65 70
Not Completed 5 5 1 5 0 5 1
Reason Not Completed
Adverse Event             0             2             0             4             0             3             0
Lack of Efficacy             3             1             1             0             0             1             0
Withdrawal by Subject             2             1             0             0             0             1             0
Protocol Violation             0             1             0             0             0             0             1
Other reason not defined above             0             0             0             1             0             0             0
Arm/Group Title Placebo Empa 1 mg Empa 5 mg Empa 10 mg Empa 25 mg Empa 50 mg Sitag Total
Hide Arm/Group Description Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily. Patients receive 1 mg Empagliflozin in tablets once daily. Patients receive 5 mg Empagliflozin in tablets once daily. Patients receive 10 mg Empagliflozin in tablets once daily. Patients receive 25 mg Empagliflozin in tablets once daily. Patients receive 50 mg Empagliflozin in tablets once daily. Patients receive 100 mg Sitagliptin (open-label) in tablets once daily. Total of all reporting groups
Overall Number of Baseline Participants 71 71 71 71 70 70 71 495
Hide Baseline Analysis Population Description
Treated Set (TS) consisting of all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 71 participants 71 participants 71 participants 70 participants 70 participants 71 participants 495 participants
59.7  (8.5) 57.4  (8.8) 59.7  (7.3) 59.0  (9.0) 58.7  (8.1) 55.9  (9.4) 57.6  (10.1) 58.3  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 71 participants 71 participants 71 participants 70 participants 70 participants 71 participants 495 participants
Female
38
  53.5%
30
  42.3%
42
  59.2%
38
  53.5%
33
  47.1%
31
  44.3%
33
  46.5%
245
  49.5%
Male
33
  46.5%
41
  57.7%
29
  40.8%
33
  46.5%
37
  52.9%
39
  55.7%
38
  53.5%
250
  50.5%
1.Primary Outcome
Title Change From Baseline in HbA1c After 12 Weeks of Treatment
Hide Description

Change from baseline in HbA1c after 12 weeks of treatment.

In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug and has a baseline measurement of the primary endpoint. The imputation method used was a modified last observation carried forward (LOCF) approach which used linear interpolation, LOCF and worst observation carried forward (WOCF).
Arm/Group Title Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Hide Arm/Group Description:
Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
Patients receive 1 mg Empagliflozin in tablets once daily.
Patients receive 5 mg Empagliflozin in tablets once daily.
Patients receive 10 mg Empagliflozin in tablets once daily.
Patients receive 25 mg Empagliflozin in tablets once daily.
Patients receive 50 mg Empagliflozin in tablets once daily.
Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
Overall Number of Participants Analyzed 71 71 71 71 70 70 71
Mean (Standard Error)
Unit of Measure: percentage of HbA1c
0.15  (0.08) -0.09  (0.08) -0.23  (0.08) -0.56  (0.08) -0.55  (0.08) -0.49  (0.08) -0.45  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0226
Comments P-values are regarded as descriptive, adjustment for multiple testing was not necessary.
Method ANCOVA
Comments Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.44 to -0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Difference calculated as empagliflozin 1 mg minus placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments P-values are regarded as descriptive, adjustment for multiple testing was not necessary.
Method ANCOVA
Comments Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.59 to -0.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Difference calculated as empagliflozin 5 mg minus placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-values are regarded as descriptive, adjustment for multiple testing was not necessary.
Method ANCOVA
Comments Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-0.91 to -0.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Difference calculated as empagliflozin 10 mg minus placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-values are regarded as descriptive, adjustment for multiple testing was not necessary.
Method ANCOVA
Comments Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-0.91 to -0.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Difference calculated as empagliflozin 25 mg minus placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-values are regarded as descriptive, adjustment for multiple testing was not necessary.
Method ANCOVA
Comments Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-0.84 to -0.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Difference calculated as empagliflozin 50 mg minus placebo
2.Secondary Outcome
Title Change of FPG From Baseline After 12 Weeks of Treatment
Hide Description

Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.

In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS using modified LOCF imputation method
Arm/Group Title Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Hide Arm/Group Description:
Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
Patients receive 1 mg Empagliflozin in tablets once daily.
Patients receive 5 mg Empagliflozin in tablets once daily.
Patients receive 10 mg Empagliflozin in tablets once daily.
Patients receive 25 mg Empagliflozin in tablets once daily.
Patients receive 50 mg Empagliflozin in tablets once daily.
Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
Overall Number of Participants Analyzed 69 68 70 68 69 69 69
Mean (Standard Error)
Unit of Measure: mg/dL
4.75  (3.48) -1.70  (3.49) -15.84  (3.45) -22.14  (3.49) -26.83  (3.47) -27.91  (3.47) -12.92  (4.73)
3.Secondary Outcome
Title Change of HbA1c From Baseline Over Time
Hide Description Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.
Time Frame Baseline and weeks 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. Imputation method used was the classical LOCF (CLOCF) approach which uses always the last available value.
Arm/Group Title Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Hide Arm/Group Description:
Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
Patients receive 1 mg Empagliflozin in tablets once daily.
Patients receive 5 mg Empagliflozin in tablets once daily.
Patients receive 10 mg Empagliflozin in tablets once daily.
Patients receive 25 mg Empagliflozin in tablets once daily.
Patients receive 50 mg Empagliflozin in tablets once daily.
Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
Overall Number of Participants Analyzed 71 71 71 71 70 70 71
Mean (Standard Error)
Unit of Measure: percentage of HbA1c
Week 4 0.02  (0.06) -0.12  (0.06) -0.16  (0.06) -0.32  (0.06) -0.31  (0.06) -0.36  (0.06) -0.26  (0.06)
Week 8 0.05  (0.07) -0.14  (0.07) -0.30  (0.07) -0.57  (0.07) -0.52  (0.07) -0.53  (0.07) -0.40  (0.07)
Week 12 0.12  (0.08) -0.08  (0.08) -0.27  (0.08) -0.57  (0.08) -0.59  (0.08) -0.50  (0.08) -0.45  (0.08)
4.Secondary Outcome
Title Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment
Hide Description Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (CLOCF)
Arm/Group Title Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Hide Arm/Group Description:
Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
Patients receive 1 mg Empagliflozin in tablets once daily.
Patients receive 5 mg Empagliflozin in tablets once daily.
Patients receive 10 mg Empagliflozin in tablets once daily.
Patients receive 25 mg Empagliflozin in tablets once daily.
Patients receive 50 mg Empagliflozin in tablets once daily.
Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
Overall Number of Participants Analyzed 71 71 71 71 70 70 71
Measure Type: Number
Unit of Measure: percentage of participants
15.5 23.9 21.1 38.0 37.1 35.7 33.8
5.Secondary Outcome
Title Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment
Hide Description Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (CLOCF)
Arm/Group Title Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Hide Arm/Group Description:
Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
Patients receive 1 mg Empagliflozin in tablets once daily.
Patients receive 5 mg Empagliflozin in tablets once daily.
Patients receive 10 mg Empagliflozin in tablets once daily.
Patients receive 25 mg Empagliflozin in tablets once daily.
Patients receive 50 mg Empagliflozin in tablets once daily.
Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
Overall Number of Participants Analyzed 71 71 71 71 70 70 71
Measure Type: Number
Unit of Measure: percentage of participants
21.1 31.0 40.8 60.6 60.0 48.6 53.5
6.Secondary Outcome
Title Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)
Hide Description Results for change of FPI from baseline at week 12 based on ANCOVA
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (CLOCF)
Arm/Group Title Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Hide Arm/Group Description:
Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
Patients receive 1 mg Empagliflozin in tablets once daily.
Patients receive 5 mg Empagliflozin in tablets once daily.
Patients receive 10 mg Empagliflozin in tablets once daily.
Patients receive 25 mg Empagliflozin in tablets once daily.
Patients receive 50 mg Empagliflozin in tablets once daily.
Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
Overall Number of Participants Analyzed 63 59 60 59 57 61 59
Mean (Standard Error)
Unit of Measure: mU/L
0.43  (0.57) 0.09  (0.59) -0.84  (0.58) -1.77  (0.58) -0.11  (0.59) -1.52  (0.57) 1.84  (0.58)
7.Secondary Outcome
Title Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)
Hide Description HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (CLOCF)
Arm/Group Title Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Hide Arm/Group Description:
Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
Patients receive 1 mg Empagliflozin in tablets once daily.
Patients receive 5 mg Empagliflozin in tablets once daily.
Patients receive 10 mg Empagliflozin in tablets once daily.
Patients receive 25 mg Empagliflozin in tablets once daily.
Patients receive 50 mg Empagliflozin in tablets once daily.
Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
Overall Number of Participants Analyzed 62 58 59 59 57 59 59
Mean (Standard Error)
Unit of Measure: mU/L x mmol/L
0.23  (0.26) -0.11  (0.27) -0.60  (0.26) -1.04  (0.26) -0.52  (0.27) -1.10  (0.27) 0.48  (0.26)
8.Secondary Outcome
Title Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)
Hide Description HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA.
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (CLOCF)
Arm/Group Title Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Hide Arm/Group Description:
Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
Patients receive 1 mg Empagliflozin in tablets once daily.
Patients receive 5 mg Empagliflozin in tablets once daily.
Patients receive 10 mg Empagliflozin in tablets once daily.
Patients receive 25 mg Empagliflozin in tablets once daily.
Patients receive 50 mg Empagliflozin in tablets once daily.
Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
Overall Number of Participants Analyzed 62 58 58 59 57 59 59
Mean (Standard Error)
Unit of Measure: mU / mmol
0.30  (2.70) 0.08  (2.77) 0.36  (2.76) 1.55  (2.72) 6.68  (2.78) 4.01  (2.76) 12.38  (2.75)
9.Secondary Outcome
Title Change of Body Weight After 12 Weeks of Treatment
Hide Description Results for change of body weight after 12 weeks of treatment based on ANCOVA.
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (CLOCF)
Arm/Group Title Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Hide Arm/Group Description:
Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
Patients receive 1 mg Empagliflozin in tablets once daily.
Patients receive 5 mg Empagliflozin in tablets once daily.
Patients receive 10 mg Empagliflozin in tablets once daily.
Patients receive 25 mg Empagliflozin in tablets once daily.
Patients receive 50 mg Empagliflozin in tablets once daily.
Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
Overall Number of Participants Analyzed 71 71 71 71 70 70 71
Mean (Standard Error)
Unit of Measure: kg
-1.16  (0.31) -1.55  (0.31) -2.28  (0.31) -2.74  (0.31) -2.56  (0.31) -2.85  (0.32) -0.84  (0.31)
10.Secondary Outcome
Title Trough Concentrations of Empagliflozin in Plasma
Hide Description (Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.
Time Frame Days 28, 56 and 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.
Arm/Group Title Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg
Hide Arm/Group Description:
Patients receive 1 mg Empagliflozin in tablets once daily.
Patients receive 5 mg Empagliflozin in tablets once daily.
Patients receive 10 mg Empagliflozin in tablets once daily.
Patients receive 25 mg Empagliflozin in tablets once daily.
Patients receive 50 mg Empagliflozin in tablets once daily.
Overall Number of Participants Analyzed 58 65 64 61 63
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 28 (N=58, 65, 62, 58, 63)
3.19
(88.8%)
13.1
(79.4%)
27.3
(127%)
92.5
(111%)
119
(78.7%)
Day 56 (N=56, 64, 64, 61, 61)
2.93
(69.6%)
11.5
(63.2%)
23.0
(93.8%)
75.4
(140%)
119
(85.5%)
Day 84 (N=53, 61, 59, 57, 57)
2.87
(80.1%)
11.2
(69.6%)
23.4
(85.1%)
71.0
(111%)
112
(79.6%)
Time Frame From first dose of study medication until 7 days following the last intake of study medication, up to 100 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Hide Arm/Group Description Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily. Patients receive 1 mg Empagliflozin in tablets once daily. Patients receive 5 mg Empagliflozin in tablets once daily. Patients receive 10 mg Empagliflozin in tablets once daily. Patients receive 25 mg Empagliflozin in tablets once daily. Patients receive 50 mg Empagliflozin in tablets once daily. Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
All-Cause Mortality
Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
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
Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/71 (2.82%)   0/71 (0.00%)   3/71 (4.23%)   1/71 (1.41%)   2/70 (2.86%)   3/70 (4.29%)   0/71 (0.00%) 
Cardiac disorders               
Atrial fibrillation  1  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/70 (0.00%)  0/71 (0.00%) 
Coronary artery disease  1  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/70 (0.00%)  0/71 (0.00%) 
Myocardial infarction  1  1/71 (1.41%)  0/71 (0.00%)  1/71 (1.41%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%)  0/71 (0.00%) 
Myocardial ischaemia  1  1/71 (1.41%)  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%)  0/71 (0.00%) 
Endocrine disorders               
Thyroid cyst  1  0/71 (0.00%)  0/71 (0.00%)  1/71 (1.41%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%)  0/71 (0.00%) 
General disorders               
Chest discomfort  1  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/70 (0.00%)  0/71 (0.00%) 
Chest pain  1  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/70 (1.43%)  0/71 (0.00%) 
Hepatobiliary disorders               
Cholecystitis acute  1  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/70 (0.00%)  0/71 (0.00%) 
Infections and infestations               
Pneumonia  1  1/71 (1.41%)  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/70 (1.43%)  0/71 (0.00%) 
Pyelonephritis  1  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/70 (1.43%)  0/71 (0.00%) 
Injury, poisoning and procedural complications               
Arthropod bite  1  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/70 (1.43%)  0/71 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Chronic lymphocytic leukaemia  1  0/71 (0.00%)  0/71 (0.00%)  1/71 (1.41%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%)  0/71 (0.00%) 
Skin and subcutaneous tissue disorders               
Urticaria  1  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/70 (1.43%)  0/71 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Empagliflozin 1 mg Empagliflozin 5 mg Empagliflozin 10 mg Empagliflozin 25 mg Empagliflozin 50 mg Sitagliptin OL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/71 (5.63%)   2/71 (2.82%)   2/71 (2.82%)   7/71 (9.86%)   4/70 (5.71%)   3/70 (4.29%)   4/71 (5.63%) 
Infections and infestations               
Urinary tract infection  1  2/71 (2.82%)  2/71 (2.82%)  1/71 (1.41%)  3/71 (4.23%)  4/70 (5.71%)  1/70 (1.43%)  2/71 (2.82%) 
Vascular disorders               
Hypertension  1  2/71 (2.82%)  0/71 (0.00%)  1/71 (1.41%)  4/71 (5.63%)  0/70 (0.00%)  2/70 (2.86%)  2/71 (2.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 12.0
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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00749190     History of Changes
Other Study ID Numbers: 1245.10
EudraCT 2008-000641-54
First Submitted: September 8, 2008
First Posted: September 9, 2008
Results First Submitted: May 16, 2014
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014