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Trial record 90 of 187 for:    BI10773

Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01193218
Recruitment Status : Completed
First Posted : September 1, 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 (low dose)
Drug: Placebo (mid dose)
Drug: Placebo (high dose)
Drug: BI 10773
Enrollment 547
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo/Empa 10mg Placebo/Empa 25 mg Empa 5mg/10mg Empa 5 mg/25 mg Empa 10mg Empa 25mg Empa 50mg\10mg Empa 50 mg/25 mg
Hide Arm/Group Description It is actually placebo once daily group in the 12-week first treatment period, and placebo/empagliflozin 10 mg once daily group in the 40-week second treatment period It is actually N/A in the 12-week first treatment period, and placebo/empagliflozin 25 mg once daily group in the 40-week second treatment period It is actually empagliflozin 5 mg once daily group in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period It is actually N/A in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period Empagliflozin 10 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period Empagliflozin 25 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period It is actually empagliflozin 50 mg once daily group in the 12-week first treatment period, and empagliflozin 50 mg/10 mg once daily group in the 40-week second treatment period It is actually N/A in the 12-week first treatment period, and empagliflozin 50 mg/25 mg once daily group in the 40-week second treatment period
Period Title: 0-12 Weeks
Started 109 [1] 0 [2] 110 [3] 0 [2] 109 109 110 [4] 0 [2]
Completed 100 0 107 0 108 106 107 0
Not Completed 9 0 3 0 1 3 3 0
Reason Not Completed
Adverse Event             6             0             1             0             0             2             2             0
Protocol Violation             0             0             0             0             1             1             0             0
Withdrawal by Subject             3             0             2             0             0             0             1             0
[1]
It is actually placebo group
[2]
It is actually N/A
[3]
It is actually empa 5mg group
[4]
It is actually empa 50mg group
Period Title: 12-52 Weeks
Started 50 50 54 53 108 106 54 53
Completed 45 50 50 50 104 101 51 49
Not Completed 5 0 4 3 4 5 3 4
Reason Not Completed
Adverse Event             1             0             1             2             3             3             1             2
Lack of Efficacy             0             0             0             0             0             0             1             0
Withdrawal by Subject             3             0             3             0             0             2             1             2
Other reason than above             1             0             0             1             1             0             0             0
Arm/Group Title Placebo (12 Week) Empa 5mg (12 Week) Empa 10mg (12 Week) Empa 25mg (12 Week) Empa 50mg (12 Week) Total
Hide Arm/Group Description Placebo once daily group in the 12-week first treatment period Empagliflozin 5 mg once daily group in the 12-week first treatment period Empagliflozin 10 mg once daily group in the 12-week first treatment period Empagliflozin 25 mg once daily group in the 12-week first treatment period Empagliflozin 50 mg once daily group in the 12-week first treatment period Total of all reporting groups
Overall Number of Baseline Participants 109 110 109 109 110 547
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 110 participants 109 participants 109 participants 110 participants 547 participants
58.7  (8.7) 57.3  (11.2) 57.9  (9.4) 57.2  (9.7) 56.6  (10.3) 57.5  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 110 participants 109 participants 109 participants 110 participants 547 participants
Female
29
  26.6%
26
  23.6%
32
  29.4%
25
  22.9%
25
  22.7%
137
  25.0%
Male
80
  73.4%
84
  76.4%
77
  70.6%
84
  77.1%
85
  77.3%
410
  75.0%
1.Primary Outcome
Title Change From Baseline in HbA1c After 12 Weeks of Treatment.
Hide Description The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS)
Arm/Group Title Placebo (12 Week) Empa 5mg (12 Week) Empa 10mg (12 Week) Empa 25mg (12 Week) Empa 50mg (12 Week)
Hide Arm/Group Description:
Placebo once daily group in the 12-week first treatment period
Empagliflozin 5 mg once daily group in the 12-week first treatment period
Empagliflozin 10 mg once daily group in the 12-week first treatment period
Empagliflozin 25 mg once daily group in the 12-week first treatment period
Empagliflozin 50 mg once daily group in the 12-week first treatment period
Overall Number of Participants Analyzed 109 110 109 109 110
Least Squares Mean (Standard Error)
Unit of Measure: percentage of HbA1c
0.30  (0.09) -0.42  (0.09) -0.40  (0.09) -0.65  (0.09) -0.61  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 5mg (12 Week)
Comments Difference calculated as empa 5mg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.
Method ANCOVA
Comments ‘treatment’, ‘renal function’, and ‘number of previous antidiabetic medication’ as a fixed effect and baseline HbA1c as a covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-0.87 to -0.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 10mg (12 Week)
Comments Difference calculated as empa 10mg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.
Method ANCOVA
Comments ‘treatment’, ‘renal function’, and ‘number of previous antidiabetic medication’ as a fixed effect and baseline HbA1c as a covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-0.85 to -0.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 25mg (12 Week)
Comments Difference calculated as empa 25mg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.
Method ANCOVA
Comments ‘treatment’, ‘renal function’, and ‘number of previous antidiabetic medication’ as a fixed effect and baseline HbA1c as a covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-1.10 to -0.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 50mg (12 Week)
Comments Difference calculated as empa 50mg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.
Method ANCOVA
Comments ‘treatment’, ‘renal function’, and ‘number of previous antidiabetic medication’ as a fixed effect and baseline HbA1c as a covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-1.06 to -0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Occurrence of Treat to Target Efficacy Response
Hide Description Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS)
Arm/Group Title Placebo (12 Week) Empa 5mg (12 Week) Empa 10mg (12 Week) Empa 25mg (12 Week) Empa 50mg (12 Week)
Hide Arm/Group Description:
Placebo once daily group in the 12-week first treatment period
Empagliflozin 5 mg once daily group in the 12-week first treatment period
Empagliflozin 10 mg once daily group in the 12-week first treatment period
Empagliflozin 25 mg once daily group in the 12-week first treatment period
Empagliflozin 50 mg once daily group in the 12-week first treatment period
Overall Number of Participants Analyzed 106 107 105 106 107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.8
(0.6 to 8.0)
26.2
(18.1 to 35.6)
19.0
(12.0 to 27.9)
32.1
(23.3 to 41.8)
32.7
(24.0 to 42.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 5mg (12 Week)
Comments Odds ratio calculated as the odds of Empa 5mg divided by the odds of placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The model includes ‘treatment’, ‘renal function’, ‘number of previous antidiabetic medications’ and ‘continuous baseline HbA1c’.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 19.367
Confidence Interval (2-Sided) 95%
5.340 to 70.236
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 10mg (12 Week)
Comments Odds ratio calculated as the odds of Empa 10mg divided by the odds of placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Regression, Logistic
Comments The model includes ‘treatment’, ‘renal function’, ‘number of previous antidiabetic medications’ and ‘continuous baseline HbA1c’.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 10.889
Confidence Interval (2-Sided) 95%
2.942 to 40.301
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 25mg (12 Week)
Comments Odds ratio calculated as the odds of Empa 25mg divided by the odds of placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The model includes ‘treatment’, ‘renal function’, ‘number of previous antidiabetic medications’ and ‘continuous baseline HbA1c’.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 27.624
Confidence Interval (2-Sided) 95%
7.601 to 99.99
Estimation Comments The upper limit of confidence interval is actually >99.99
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 50mg (12 Week)
Comments Odds ratio calculated as the odds of Empa 50mg divided by the odds of placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The model includes ‘treatment’, ‘renal function’, ‘number of previous antidiabetic medications’ and ‘continuous baseline HbA1c’.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 44.906
Confidence Interval (2-Sided) 95%
12.120 to 99.99
Estimation Comments The upper limit of confidence interval is actually >99.99
3.Secondary Outcome
Title Change From Baseline in FPG
Hide Description Change from baseline in FPG after 12 weeks of treatment
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS)
Arm/Group Title Placebo (12 Week) Empa 5mg (12 Week) Empa 10mg (12 Week) Empa 25mg (12 Week) Empa 50mg (12 Week)
Hide Arm/Group Description:
Placebo once daily group in the 12-week first treatment period
Empagliflozin 5 mg once daily group in the 12-week first treatment period
Empagliflozin 10 mg once daily group in the 12-week first treatment period
Empagliflozin 25 mg once daily group in the 12-week first treatment period
Empagliflozin 50 mg once daily group in the 12-week first treatment period
Overall Number of Participants Analyzed 109 110 109 109 110
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
4.06  (2.88) -22.65  (2.97) -25.28  (2.77) -33.70  (2.92) -32.54  (2.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 5mg (12 Week)
Comments Difference calculated as empa 5mg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -26.70
Confidence Interval (2-Sided) 95%
-31.61 to -21.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 10mg (12 Week)
Comments Difference calculated as empa 10mg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.34
Confidence Interval (2-Sided) 95%
-34.25 to -24.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.50
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 25mg (12 Week)
Comments Difference calculated as empa 25mg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -37.75
Confidence Interval (2-Sided) 95%
-42.66 to -32.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.50
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (12 Week), Empa 50mg (12 Week)
Comments Difference calculated as empa 50mg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -36.60
Confidence Interval (2-Sided) 95%
-41.51 to -31.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.50
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Confirmed Hypoglycaemic Adverse Events
Hide Description Number of patients with confirmed hypoglycaemic adverse events
Time Frame between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title Placebo (12 Week) Empa 5mg (12 Week) Empa 10mg (12 Week) Empa 25mg (12 Week) Empa 50mg (12 Week)
Hide Arm/Group Description:
Placebo once daily group in the 12-week first treatment period
Empagliflozin 5 mg once daily group in the 12-week first treatment period
Empagliflozin 10 mg once daily group in the 12-week first treatment period
Empagliflozin 25 mg once daily group in the 12-week first treatment period
Empagliflozin 50 mg once daily group in the 12-week first treatment period
Overall Number of Participants Analyzed 109 110 109 109 110
Measure Type: Number
Unit of Measure: participants
0 0 0 1 1
Time Frame between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (12 Week) Empa 5mg (12 Week) Empa 10mg (12 Week) Empa 25mg (12 Week) Empa 50mg (12 Week) Empa 10mg (Randomized, 52 Week) Empa 25mg (Randomized, 52 Week) Empa 10mg (With at Least One Dose, 52 Week) Empa 25mg (With at Least One Dose, 52 Week)
Hide Arm/Group Description Placebo once daily group in the 12-week first treatment period Empagliflozin 5 mg once daily group in the 12-week first treatment period Empagliflozin 10 mg once daily group in the 12-week first treatment period Empagliflozin 25 mg once daily group in the 12-week first treatment period Empagliflozin 50 mg once daily group in the 12-week first treatment period Patients randomized to empagliflozin 10mg once daily for 52 weeks Patients randomized to empagliflozin 25 mg once daily for 52 weeks Patients with at least one dose of empagliflozin 10 mg once daily for 52−week treatment Patients with at least one dose of empagliflozin 25 mg once daily for 52−week treatment
All-Cause Mortality
Placebo (12 Week) Empa 5mg (12 Week) Empa 10mg (12 Week) Empa 25mg (12 Week) Empa 50mg (12 Week) Empa 10mg (Randomized, 52 Week) Empa 25mg (Randomized, 52 Week) Empa 10mg (With at Least One Dose, 52 Week) Empa 25mg (With at Least One Dose, 52 Week)
Affected / at Risk (%) 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
Placebo (12 Week) Empa 5mg (12 Week) Empa 10mg (12 Week) Empa 25mg (12 Week) Empa 50mg (12 Week) Empa 10mg (Randomized, 52 Week) Empa 25mg (Randomized, 52 Week) Empa 10mg (With at Least One Dose, 52 Week) Empa 25mg (With at Least One Dose, 52 Week)
Affected / at Risk (%) 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   3/109 (2.75%)   0/110 (0.00%)   0/109 (0.00%)   3/109 (2.75%)   1/110 (0.91%)   3/109 (2.75%)   8/109 (7.34%)   8/267 (3.00%)   15/265 (5.66%) 
Cardiac disorders                   
Acute myocardial infarction  1  1/109 (0.92%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  1/267 (0.37%)  0/265 (0.00%) 
Left ventricular hypertrophy  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  1/110 (0.91%)  0/109 (0.00%)  0/109 (0.00%)  0/267 (0.00%)  0/265 (0.00%) 
Myocardial infarction  1  1/109 (0.92%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/267 (0.00%)  0/265 (0.00%) 
Ear and labyrinth disorders                   
Sudden hearing loss  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/267 (0.00%)  1/265 (0.38%) 
Eye disorders                   
Glaucoma  1  1/109 (0.92%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/267 (0.00%)  0/265 (0.00%) 
Macular hole  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  1/267 (0.37%)  0/265 (0.00%) 
Gastrointestinal disorders                   
Colonic polyp  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  1/109 (0.92%)  0/109 (0.00%)  1/267 (0.37%)  0/265 (0.00%) 
Duodenal ulcer  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/267 (0.00%)  1/265 (0.38%) 
Gastric ulcer  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/267 (0.00%)  1/265 (0.38%) 
General disorders                   
Device dislocation  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/267 (0.00%)  1/265 (0.38%) 
Pyrexia  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  0/267 (0.00%)  1/265 (0.38%) 
Hepatobiliary disorders                   
Hepatic function abnormal  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/267 (0.00%)  1/265 (0.38%) 
Hyperbilirubinaemia  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  0/267 (0.00%)  1/265 (0.38%) 
Infections and infestations                   
Pharyngitis  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  0/267 (0.00%)  1/265 (0.38%) 
Tonsillitis  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/267 (0.00%)  1/265 (0.38%) 
Viral infection  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  1/109 (0.92%)  0/109 (0.00%)  1/267 (0.37%)  0/265 (0.00%) 
Injury, poisoning and procedural complications                   
Ankle fracture  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/267 (0.00%)  1/265 (0.38%) 
Joint dislocation  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/267 (0.00%)  1/265 (0.38%) 
Investigations                   
Carbohydrate antigen 19-9 increased  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  0/267 (0.00%)  1/265 (0.38%) 
Prostatic specific antigen increased  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  1/109 (0.92%)  0/109 (0.00%)  1/267 (0.37%)  1/265 (0.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Bladder cancer  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  1/267 (0.37%)  0/265 (0.00%) 
Colon cancer  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  1/267 (0.37%)  1/265 (0.38%) 
Diffuse large B-cell lymphoma  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  0/267 (0.00%)  1/265 (0.38%) 
Gastric cancer  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  0/267 (0.00%)  1/265 (0.38%) 
Lipoma  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  1/267 (0.37%)  0/265 (0.00%) 
Lung cancer metastatic  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  1/267 (0.37%)  0/265 (0.00%) 
Metastases to bone marrow  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  1/267 (0.37%)  0/265 (0.00%) 
Oesophageal carcinoma  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  0/267 (0.00%)  1/265 (0.38%) 
Nervous system disorders                   
Cerebral infarction  1  0/109 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  0/110 (0.00%)  0/109 (0.00%)  1/109 (0.92%)  0/267 (0.00%)  1/265 (0.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (12 Week) Empa 5mg (12 Week) Empa 10mg (12 Week) Empa 25mg (12 Week) Empa 50mg (12 Week) Empa 10mg (Randomized, 52 Week) Empa 25mg (Randomized, 52 Week) Empa 10mg (With at Least One Dose, 52 Week) Empa 25mg (With at Least One Dose, 52 Week)
Affected / at Risk (%) 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   15/109 (13.76%)   19/110 (17.27%)   16/109 (14.68%)   26/109 (23.85%)   20/110 (18.18%)   39/109 (35.78%)   49/109 (44.95%)   83/267 (31.09%)   93/265 (35.09%) 
Gastrointestinal disorders                   
Constipation  1  3/109 (2.75%)  2/110 (1.82%)  0/109 (0.00%)  4/109 (3.67%)  2/110 (1.82%)  1/109 (0.92%)  6/109 (5.50%)  3/267 (1.12%)  10/265 (3.77%) 
Dental caries  1  0/109 (0.00%)  1/110 (0.91%)  1/109 (0.92%)  1/109 (0.92%)  0/110 (0.00%)  1/109 (0.92%)  7/109 (6.42%)  2/267 (0.75%)  9/265 (3.40%) 
Infections and infestations                   
Nasopharyngitis  1  10/109 (9.17%)  8/110 (7.27%)  9/109 (8.26%)  11/109 (10.09%)  11/110 (10.00%)  30/109 (27.52%)  33/109 (30.28%)  62/267 (23.22%)  63/265 (23.77%) 
Pharyngitis  1  1/109 (0.92%)  0/110 (0.00%)  4/109 (3.67%)  3/109 (2.75%)  2/110 (1.82%)  6/109 (5.50%)  6/109 (5.50%)  11/267 (4.12%)  9/265 (3.40%) 
Musculoskeletal and connective tissue disorders                   
Back pain  1  0/109 (0.00%)  4/110 (3.64%)  1/109 (0.92%)  0/109 (0.00%)  0/110 (0.00%)  4/109 (3.67%)  4/109 (3.67%)  14/267 (5.24%)  10/265 (3.77%) 
Renal and urinary disorders                   
Pollakiuria  1  1/109 (0.92%)  4/110 (3.64%)  1/109 (0.92%)  7/109 (6.42%)  6/110 (5.45%)  1/109 (0.92%)  8/109 (7.34%)  4/267 (1.50%)  10/265 (3.77%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.0
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
ClinicalTrials.gov Identifier: NCT01193218     History of Changes
Other Study ID Numbers: 1245.38
First Submitted: August 31, 2010
First Posted: September 1, 2010
Results First Submitted: May 16, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014