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Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01368081
Recruitment Status : Completed
First Posted : June 7, 2011
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: Metformin
Drug: BI 10773
Drug: Placebo (low dose)
Drug: Placebo (high dose)
Enrollment 1162

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sulfonylurea: Empa 10mg Sulfonylurea: Empa 25mg Sulfonylurea: Metformin Biguanide: Empa 10mg Biguanide: Empa 25mg Thiazolidinedione: Empa 10mg Thiazolidinedione: Empa 25mg Alpha Glucosidase Inhibitor: Empa 10mg Alpha Glucosidase Inhibitor: Empa 25mg DPP−IV Inhibitor: Empa 10mg DPP−IV Inhibitor: Empa 25mg Glinide: Empa 10mg Glinide: Empa 25mg
Hide Arm/Group Description One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea 250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Period Title: Overall Study
Started 136 137 63 68 65 137 136 69 70 68 71 70 70
Completed 126 128 59 63 63 127 124 62 62 58 62 67 63
Not Completed 10 9 4 5 2 10 12 7 8 10 9 3 7
Reason Not Completed
Adverse Event             4             4             3             2             2             5             6             2             3             5             6             1             3
Lack of Efficacy             0             1             0             1             0             0             0             2             0             0             0             0             0
Protocol Violation             0             0             0             0             0             1             0             1             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             1
Withdrawal by Subject             4             4             1             1             0             3             4             2             5             4             3             2             0
Other reason not defined above             2             0             0             1             0             1             2             0             0             1             0             0             3
Arm/Group Title Sulfonylurea: Empa 10mg Sulfonylurea: Empa 25mg Sulfonylurea: Metformin Biguanide: Empa 10mg Biguanide: Empa 25mg Thiazolidinedione: Empa 10mg Thiazolidinedione: Empa 25mg Alpha Glucosidase Inhibitor: Empa 10mg Alpha Glucosidase Inhibitor: Empa 25mg DPP−IV Inhibitor: Empa 10mg DPP−IV Inhibitor: Empa 25mg Glinide: Empa 10mg Glinide: Empa 25mg Total
Hide Arm/Group Description One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea 250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide Total of all reporting groups
Overall Number of Baseline Participants 136 137 63 68 65 137 136 69 70 68 71 70 70 1160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 136 participants 137 participants 63 participants 68 participants 65 participants 137 participants 136 participants 69 participants 70 participants 68 participants 71 participants 70 participants 70 participants 1160 participants
61.3  (9.9) 61.8  (9.6) 60.0  (10.2) 56.9  (9.5) 57.3  (11.4) 60.4  (10.1) 59.7  (9.9) 63.5  (8.8) 61.9  (11.7) 63.3  (9.9) 59.1  (10.3) 59.2  (12.1) 57.7  (11.8) 60.3  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 137 participants 63 participants 68 participants 65 participants 137 participants 136 participants 69 participants 70 participants 68 participants 71 participants 70 participants 70 participants 1160 participants
Female
37
  27.2%
41
  29.9%
16
  25.4%
30
  44.1%
22
  33.8%
23
  16.8%
34
  25.0%
18
  26.1%
18
  25.7%
27
  39.7%
23
  32.4%
23
  32.9%
13
  18.6%
325
  28.0%
Male
99
  72.8%
96
  70.1%
47
  74.6%
38
  55.9%
43
  66.2%
114
  83.2%
102
  75.0%
51
  73.9%
52
  74.3%
41
  60.3%
48
  67.6%
47
  67.1%
57
  81.4%
835
  72.0%
1.Primary Outcome
Title Number of Patients With Drug Related Adverse Events
Hide Description Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
Time Frame After the first drug intake until 7 days after the last treatment administration, up to 383 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title Sulfonylurea: Empa 10mg Sulfonylurea: Empa 25mg Sulfonylurea: Metformin Biguanide: Empa 10mg Biguanide: Empa 25mg Thiazolidinedione: Empa 10mg Thiazolidinedione: Empa 25mg Alpha Glucosidase Inhibitor: Empa 10mg Alpha Glucosidase Inhibitor: Empa 25mg DPP−IV Inhibitor: Empa 10mg DPP−IV Inhibitor: Empa 25mg Glinide: Empa 10mg Glinide: Empa 25mg
Hide Arm/Group Description:
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Overall Number of Participants Analyzed 136 137 63 68 65 137 136 69 70 68 71 70 70
Measure Type: Number
Unit of Measure: participants
19 25 13 13 9 20 19 7 5 9 18 9 9
2.Secondary Outcome
Title Change From Baseline in HbA1c
Hide Description Change from baseline in HbA1c after 52 weeks of treatment
Time Frame Baseline and 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Sulfonylurea: Empa 10mg Sulfonylurea: Empa 25mg Sulfonylurea: Metformin Biguanide: Empa 10mg Biguanide: Empa 25mg Thiazolidinedione: Empa 10mg Thiazolidinedione: Empa 25mg Alpha Glucosidase Inhibitor: Empa 10mg Alpha Glucosidase Inhibitor: Empa 25mg DPP−IV Inhibitor: Empa 10mg DPP−IV Inhibitor: Empa 25mg Glinide: Empa 10mg Glinide: Empa 25mg
Hide Arm/Group Description:
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Overall Number of Participants Analyzed 136 137 63 68 65 137 136 69 70 68 71 70 70
Least Squares Mean (Standard Error)
Unit of Measure: percentage of HbA1c
-0.93  (0.05) -0.96  (0.05) -0.97  (0.08) -0.81  (0.06) -0.98  (0.06) -0.90  (0.05) -0.96  (0.05) -0.87  (0.06) -0.77  (0.06) -1.00  (0.06) -0.83  (0.06) -0.98  (0.08) -0.98  (0.08)
3.Other Pre-specified Outcome
Title Confirmed Hypoglycaemic Adverse Events
Hide Description Number of patients with confirmed hypoglycaemic adverse events
Time Frame After the first drug intake until 7 days after the last treatment administration, up to 383 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title Sulfonylurea: Empa 10mg Sulfonylurea: Empa 25mg Sulfonylurea: Metformin Biguanide: Empa 10mg Biguanide: Empa 25mg Thiazolidinedione: Empa 10mg Thiazolidinedione: Empa 25mg Alpha Glucosidase Inhibitor: Empa 10mg Alpha Glucosidase Inhibitor: Empa 25mg DPP−IV Inhibitor: Empa 10mg DPP−IV Inhibitor: Empa 25mg Glinide: Empa 10mg Glinide: Empa 25mg
Hide Arm/Group Description:
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Overall Number of Participants Analyzed 136 137 63 68 65 137 136 69 70 68 71 70 70
Measure Type: Number
Unit of Measure: participants
6 9 5 0 1 2 1 0 0 0 1 0 2
Time Frame After the first drug intake until 7 days after the last treatment administration, up to 383 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sulfonylurea: Empa 10mg Sulfonylurea: Empa 25mg Sulfonylurea: Metformin Biguanide: Empa 10mg Biguanide: Empa 25mg Thiazolidinedione: Empa 10mg Thiazolidinedione: Empa 25mg Alpha-GI: Empa 10mg Alpha-GI: Empa 25mg DPP-4 Inhibitor: Empa 10mg DPP-4 Inhibitor: Empa 25mg Glinide: Empa 10mg Glinide: Empa 25mg
Hide Arm/Group Description One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea 250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
All-Cause Mortality
Sulfonylurea: Empa 10mg Sulfonylurea: Empa 25mg Sulfonylurea: Metformin Biguanide: Empa 10mg Biguanide: Empa 25mg Thiazolidinedione: Empa 10mg Thiazolidinedione: Empa 25mg Alpha-GI: Empa 10mg Alpha-GI: Empa 25mg DPP-4 Inhibitor: Empa 10mg DPP-4 Inhibitor: Empa 25mg Glinide: Empa 10mg Glinide: Empa 25mg
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sulfonylurea: Empa 10mg Sulfonylurea: Empa 25mg Sulfonylurea: Metformin Biguanide: Empa 10mg Biguanide: Empa 25mg Thiazolidinedione: Empa 10mg Thiazolidinedione: Empa 25mg Alpha-GI: Empa 10mg Alpha-GI: Empa 25mg DPP-4 Inhibitor: Empa 10mg DPP-4 Inhibitor: Empa 25mg Glinide: Empa 10mg Glinide: Empa 25mg
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/136 (7.35%)   7/137 (5.11%)   3/63 (4.76%)   7/68 (10.29%)   2/65 (3.08%)   12/137 (8.76%)   12/136 (8.82%)   2/69 (2.90%)   5/70 (7.14%)   7/68 (10.29%)   5/71 (7.04%)   1/70 (1.43%)   4/70 (5.71%) 
Blood and lymphatic system disorders                           
Anaemia  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  1/70 (1.43%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Cardiac disorders                           
Acute myocardial infarction  1  1/136 (0.74%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  1/68 (1.47%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Congestive cardiomyopathy  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Coronary artery stenosis  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  1/68 (1.47%)  1/65 (1.54%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Myocardial infarction  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  1/68 (1.47%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Prinzmetal angina  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Angina pectoris  1  1/136 (0.74%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Arteriosclerosis coronary artery  1  1/136 (0.74%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Atrial fibrillation  1  0/136 (0.00%)  1/137 (0.73%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Cardiac failure congestive  1  0/136 (0.00%)  1/137 (0.73%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Eye disorders                           
Cataract  1  0/136 (0.00%)  2/137 (1.46%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/70 (0.00%) 
Glaucoma  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/70 (1.43%) 
Retinal detachment  1  0/136 (0.00%)  1/137 (0.73%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Gastrointestinal disorders                           
Anal fissure  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  1/70 (1.43%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Gastrointestinal haemorrhage  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  1/70 (1.43%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Haemorrhoids  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/70 (0.00%) 
Inguinal hernia  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/70 (0.00%) 
Colitis ischaemic  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Colonic polyp  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Duodenitis  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Leukoplakia oral  1  1/136 (0.74%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Megacolon  1  1/136 (0.74%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Melaena  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
General disorders                           
Chest pain  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Hepatobiliary disorders                           
Drug-induced liver injury  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Immune system disorders                           
Anaphylactic reaction  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  1/69 (1.45%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Infections and infestations                           
Urinary tract infection  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Cellulitis  1  0/136 (0.00%)  1/137 (0.73%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/70 (1.43%) 
Febrile infection  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/70 (0.00%) 
Gangrene  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/70 (1.43%) 
Osteomyelitis  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/70 (1.43%) 
Pneumonia  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Pulmonary tuberculosis  1  0/136 (0.00%)  1/137 (0.73%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Pyelonephritis  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Injury, poisoning and procedural complications                           
Femur fracture  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  1/68 (1.47%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Ankle fracture  1  0/136 (0.00%)  1/137 (0.73%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Heat illness  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Pelvic fracture  1  1/136 (0.74%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Subdural haematoma  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Musculoskeletal and connective tissue disorders                           
Intervertebral disc protrusion  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  1/68 (1.47%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Lumbar spinal stenosis  1  1/136 (0.74%)  0/137 (0.00%)  0/63 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Polyarthritis  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  1/69 (1.45%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Rotator cuff syndrome  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Spinal column stenosis  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                           
Colon cancer  1  0/136 (0.00%)  0/137 (0.00%)  1/63 (1.59%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/70 (1.43%) 
Gastric cancer  1  0/136 (0.00%)  1/137 (0.73%)  1/63 (1.59%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/70 (0.00%) 
Lung neoplasm malignant  1  0/136 (0.00%)  0/137 (0.00%)  1/63 (1.59%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Benign ovarian tumour  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  1/68 (1.47%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Prostate cancer  1  1/136 (0.74%)  1/137 (0.73%)  0/63 (0.00%)  0/68 (0.00%)  1/65 (1.54%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  1/70 (1.43%)  0/68 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/70 (0.00%) 
Meningioma  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/70 (0.00%) 
Oropharyngeal cancer stage unspecified  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/70 (1.43%) 
Uterine cancer  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  1/70 (1.43%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Rectal cancer  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Small cell lung cancer stage unspecified  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Nervous system disorders                           
Lacunar infarction  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  1/68 (1.47%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Carotid artery stenosis  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Cerebral arteriosclerosis  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Cerebral infarction  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Transient ischaemic attack  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
VIIth nerve paralysis  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Psychiatric disorders                           
Schizophrenia  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  1/70 (1.43%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Renal and urinary disorders                           
Bladder prolapse  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  1/68 (1.47%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Calculus ureteric  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Diabetic nephropathy  1  1/136 (0.74%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Nephrolithiasis  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  1/136 (0.74%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Reproductive system and breast disorders                           
Benign prostatic hyperplasia  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  1/68 (1.47%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders                           
Hyperventilation  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  1/137 (0.73%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Sleep apnoea syndrome  1  1/136 (0.74%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Vascular disorders                           
Embolism arterial  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  1/70 (1.43%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Artery dissection  1  1/136 (0.74%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Peripheral arterial occlusive disease  1  1/136 (0.74%)  0/137 (0.00%)  0/63 (0.00%)  0/68 (0.00%)  0/65 (0.00%)  0/137 (0.00%)  0/136 (0.00%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/70 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sulfonylurea: Empa 10mg Sulfonylurea: Empa 25mg Sulfonylurea: Metformin Biguanide: Empa 10mg Biguanide: Empa 25mg Thiazolidinedione: Empa 10mg Thiazolidinedione: Empa 25mg Alpha-GI: Empa 10mg Alpha-GI: Empa 25mg DPP-4 Inhibitor: Empa 10mg DPP-4 Inhibitor: Empa 25mg Glinide: Empa 10mg Glinide: Empa 25mg
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   73/136 (53.68%)   74/137 (54.01%)   44/63 (69.84%)   32/68 (47.06%)   35/65 (53.85%)   77/137 (56.20%)   74/136 (54.41%)   40/69 (57.97%)   34/70 (48.57%)   37/68 (54.41%)   36/71 (50.70%)   30/70 (42.86%)   38/70 (54.29%) 
Gastrointestinal disorders                           
Constipation  1  5/136 (3.68%)  5/137 (3.65%)  2/63 (3.17%)  4/68 (5.88%)  3/65 (4.62%)  9/137 (6.57%)  1/136 (0.74%)  1/69 (1.45%)  8/70 (11.43%)  5/68 (7.35%)  7/71 (9.86%)  3/70 (4.29%)  0/70 (0.00%) 
Diarrhoea  1  2/136 (1.47%)  2/137 (1.46%)  5/63 (7.94%)  6/68 (8.82%)  4/65 (6.15%)  5/137 (3.65%)  2/136 (1.47%)  2/69 (2.90%)  4/70 (5.71%)  0/68 (0.00%)  1/71 (1.41%)  1/70 (1.43%)  1/70 (1.43%) 
Gastritis  1  3/136 (2.21%)  2/137 (1.46%)  2/63 (3.17%)  1/68 (1.47%)  1/65 (1.54%)  4/137 (2.92%)  2/136 (1.47%)  2/69 (2.90%)  4/70 (5.71%)  0/68 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  2/70 (2.86%) 
General disorders                           
Thirst  1  2/136 (1.47%)  0/137 (0.00%)  0/63 (0.00%)  4/68 (5.88%)  0/65 (0.00%)  0/137 (0.00%)  2/136 (1.47%)  0/69 (0.00%)  0/70 (0.00%)  1/68 (1.47%)  0/71 (0.00%)  2/70 (2.86%)  0/70 (0.00%) 
Infections and infestations                           
Nasopharyngitis  1  41/136 (30.15%)  38/137 (27.74%)  26/63 (41.27%)  12/68 (17.65%)  23/65 (35.38%)  44/137 (32.12%)  37/136 (27.21%)  26/69 (37.68%)  21/70 (30.00%)  23/68 (33.82%)  15/71 (21.13%)  16/70 (22.86%)  17/70 (24.29%) 
Influenza  1  1/136 (0.74%)  2/137 (1.46%)  5/63 (7.94%)  3/68 (4.41%)  2/65 (3.08%)  1/137 (0.73%)  3/136 (2.21%)  2/69 (2.90%)  2/70 (2.86%)  2/68 (2.94%)  0/71 (0.00%)  0/70 (0.00%)  3/70 (4.29%) 
Pharyngitis  1  3/136 (2.21%)  7/137 (5.11%)  2/63 (3.17%)  1/68 (1.47%)  1/65 (1.54%)  6/137 (4.38%)  6/136 (4.41%)  0/69 (0.00%)  2/70 (2.86%)  2/68 (2.94%)  5/71 (7.04%)  2/70 (2.86%)  5/70 (7.14%) 
Vulvovaginal candidiasis  1  0/136 (0.00%)  0/137 (0.00%)  0/63 (0.00%)  4/68 (5.88%)  1/65 (1.54%)  2/137 (1.46%)  1/136 (0.74%)  2/69 (2.90%)  3/70 (4.29%)  0/68 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/70 (0.00%) 
Gastroenteritis  1  1/136 (0.74%)  4/137 (2.92%)  2/63 (3.17%)  0/68 (0.00%)  2/65 (3.08%)  4/137 (2.92%)  1/136 (0.74%)  1/69 (1.45%)  4/70 (5.71%)  1/68 (1.47%)  1/71 (1.41%)  1/70 (1.43%)  2/70 (2.86%) 
Bronchitis  1  7/136 (5.15%)  0/137 (0.00%)  0/63 (0.00%)  3/68 (4.41%)  3/65 (4.62%)  2/137 (1.46%)  5/136 (3.68%)  1/69 (1.45%)  0/70 (0.00%)  2/68 (2.94%)  3/71 (4.23%)  1/70 (1.43%)  3/70 (4.29%) 
Injury, poisoning and procedural complications                           
Fall  1  4/136 (2.94%)  6/137 (4.38%)  5/63 (7.94%)  2/68 (2.94%)  1/65 (1.54%)  9/137 (6.57%)  8/136 (5.88%)  3/69 (4.35%)  2/70 (2.86%)  4/68 (5.88%)  4/71 (5.63%)  3/70 (4.29%)  2/70 (2.86%) 
Contusion  1  2/136 (1.47%)  3/137 (2.19%)  4/63 (6.35%)  0/68 (0.00%)  1/65 (1.54%)  2/137 (1.46%)  5/136 (3.68%)  2/69 (2.90%)  4/70 (5.71%)  2/68 (2.94%)  4/71 (5.63%)  1/70 (1.43%)  1/70 (1.43%) 
Metabolism and nutrition disorders                           
Hypoglycaemia  1  11/136 (8.09%)  12/137 (8.76%)  6/63 (9.52%)  2/68 (2.94%)  3/65 (4.62%)  4/137 (2.92%)  2/136 (1.47%)  0/69 (0.00%)  0/70 (0.00%)  0/68 (0.00%)  3/71 (4.23%)  0/70 (0.00%)  3/70 (4.29%) 
Musculoskeletal and connective tissue disorders                           
Back pain  1  3/136 (2.21%)  7/137 (5.11%)  1/63 (1.59%)  0/68 (0.00%)  5/65 (7.69%)  8/137 (5.84%)  8/136 (5.88%)  2/69 (2.90%)  1/70 (1.43%)  1/68 (1.47%)  5/71 (7.04%)  4/70 (5.71%)  3/70 (4.29%) 
Nervous system disorders                           
Dizziness  1  2/136 (1.47%)  2/137 (1.46%)  2/63 (3.17%)  4/68 (5.88%)  0/65 (0.00%)  4/137 (2.92%)  4/136 (2.94%)  3/69 (4.35%)  1/70 (1.43%)  3/68 (4.41%)  2/71 (2.82%)  6/70 (8.57%)  2/70 (2.86%) 
Renal and urinary disorders                           
Pollakiuria  1  3/136 (2.21%)  6/137 (4.38%)  0/63 (0.00%)  2/68 (2.94%)  0/65 (0.00%)  11/137 (8.03%)  3/136 (2.21%)  2/69 (2.90%)  3/70 (4.29%)  4/68 (5.88%)  7/71 (9.86%)  3/70 (4.29%)  5/70 (7.14%) 
Respiratory, thoracic and mediastinal disorders                           
Upper respiratory tract inflammation  1  7/136 (5.15%)  6/137 (4.38%)  4/63 (6.35%)  0/68 (0.00%)  3/65 (4.62%)  3/137 (2.19%)  1/136 (0.74%)  1/69 (1.45%)  2/70 (2.86%)  0/68 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  1/70 (1.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.1
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: NCT01368081     History of Changes
Other Study ID Numbers: 1245.52
First Submitted: May 19, 2011
First Posted: June 7, 2011
Results First Submitted: May 16, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014