ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment

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: NCT01164501
Recruitment Status : Completed
First Posted : July 16, 2010
Results First Posted : June 16, 2014
Last Update Posted : June 16, 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
Conditions Diabetes Mellitus, Type 2
Renal Insufficiency
Interventions Drug: BI 10773
Drug: Placebo
Enrollment 741
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Empa 10mg Empa 25mg
Hide Arm/Group Description Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks. Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks. Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
Period Title: Overall Study
Started 321 98 322
Completed 278 88 280
Not Completed 43 10 42
Reason Not Completed
Not treated             2             0             1
Adverse Event             18             4             21
Lack of Efficacy             0             0             1
Non compliant with protocol             1             1             4
Lost to Follow-up             3             0             3
Patient refusal to continue,not due toAE             10             4             8
Other reason not defined above             9             1             4
Arm/Group Title Placebo Empa 10mg Empa 25mg Total
Hide Arm/Group Description Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks. Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks. Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 319 98 321 738
Hide Baseline Analysis Population Description
Baseline characteristics are presented for treated patients only.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 319 participants 98 participants 321 participants 738 participants
64.1  (8.7) 63.2  (8.5) 63.9  (9.0) 63.9  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 319 participants 98 participants 321 participants 738 participants
Female
138
  43.3%
38
  38.8%
132
  41.1%
308
  41.7%
Male
181
  56.7%
60
  61.2%
189
  58.9%
430
  58.3%
1.Primary Outcome
Title HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment
Hide Description

Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment.

Note adjusted means are provided.

Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.
Arm/Group Title Placebo Empa 25mg
Hide Arm/Group Description:
Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
Overall Number of Participants Analyzed 282 284
Mean (Standard Error)
Unit of Measure: percentage of HbA1c
0.05  (0.04) -0.46  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empa 25mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild or moderate renal impaired patients was the first step in the hierarchical sequence.
Method ANCOVA
Comments Based on ANCOVA with terms for treatment, background antidiabetic medication, renal impairment and baseline HbA1c.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.51
Confidence Interval (2-Sided) 95%
-0.62 to -0.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments Difference calculated as empa 25mg minus placebo
2.Primary Outcome
Title HbA1c Change From Baseline in Patients With Mild Renal Impairment
Hide Description

Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment.

Note adjusted means are provided.

Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.
Arm/Group Title Placebo Empa 10mg Empa 25mg
Hide Arm/Group Description:
Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
Overall Number of Participants Analyzed 95 98 97
Mean (Standard Error)
Unit of Measure: percentage of HbA1c
0.06  (0.07) -0.46  (0.07) -0.63  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empa 10mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild renal impaired patients was the second step in the hierarchical sequence.
Method ANCOVA
Comments Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.72 to -0.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Difference calculated as empa 10mg minus placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Empa 25mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in mild renal impaired patients was the third step in the hierarchical sequence.
Method ANCOVA
Comments Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-0.88 to -0.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Difference calculated as empa 25mg minus placebo
3.Primary Outcome
Title HbA1c Change From Baseline in Patients With Moderate Renal Impairment
Hide Description

Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment.

Note adjusted means are provided.

Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.
Arm/Group Title Placebo Empa 25mg
Hide Arm/Group Description:
Placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
Overall Number of Participants Analyzed 187 187
Mean (Standard Error)
Unit of Measure: percentage of HbA1c
0.05  (0.05) -0.37  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empa 25mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in moderate renal impaired patients was the fourth step in the hierarchical sequence.
Method ANCOVA
Comments Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.56 to -0.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments Difference calculated as empa 25mg minus placebo
4.Other Pre-specified Outcome
Title Hypoglycaemic Events
Hide Description Percentage of patients who experienced a hypoglycaemic event. A hypoglycaemic event was regarded as confirmed if it was documented as an adverse event with plasma glucose values <= 70 mg/dL (<=3.9mmol/L) measured or with a documentation that the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative action had been required.
Time Frame From first drug administration until 7 days after last trial medication intake, up to 458 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set which included all patients treated with at least one dose of randomised trial medication.
Arm/Group Title Placebo Empa 10mg Empa 25mg
Hide Arm/Group Description:
Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
Overall Number of Participants Analyzed 319 98 321
Measure Type: Number
Unit of Measure: percentage of participants
27.6 26.5 27.4
Time Frame From first drug administration until 7 days after last trial medication intake, up to 458 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Empa 10mg Empa 25mg
Hide Arm/Group Description Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks. Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks. Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
All-Cause Mortality
Placebo Empa 10mg Empa 25mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Empa 10mg Empa 25mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/319 (13.79%)   6/98 (6.12%)   40/321 (12.46%) 
Blood and lymphatic system disorders       
Anaemia  1  1/319 (0.31%)  0/98 (0.00%)  1/321 (0.31%) 
Thrombocytopenia  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Cardiac disorders       
Acute coronary syndrome  1  0/319 (0.00%)  1/98 (1.02%)  0/321 (0.00%) 
Acute myocardial infarction  1  2/319 (0.63%)  0/98 (0.00%)  0/321 (0.00%) 
Angina unstable  1  2/319 (0.63%)  0/98 (0.00%)  0/321 (0.00%) 
Arrhythmia  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Atrial fibrillation  1  2/319 (0.63%)  0/98 (0.00%)  1/321 (0.31%) 
Atrioventricular block  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Cardiac arrest  1  1/319 (0.31%)  0/98 (0.00%)  1/321 (0.31%) 
Cardiac failure  1  3/319 (0.94%)  0/98 (0.00%)  0/321 (0.00%) 
Cardiac failure congestive  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Cardiogenic shock  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Coronary artery occlusion  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Myocardial ischaemia  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Sick sinus syndrome  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Eye disorders       
Cataract  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Glaucoma  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Retinal artery occlusion  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Gastrointestinal disorders       
Abdominal pain  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Abdominal pain upper  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Colonic polyp  1  1/319 (0.31%)  0/98 (0.00%)  1/321 (0.31%) 
Constipation  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Diarrhoea  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Gastritis erosive  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Intestinal obstruction  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Oesophageal varices haemorrhage  1  0/319 (0.00%)  1/98 (1.02%)  0/321 (0.00%) 
Pancreatitis  1  2/319 (0.63%)  0/98 (0.00%)  0/321 (0.00%) 
Pancreatitis acute  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
General disorders       
Chest pain  1  3/319 (0.94%)  1/98 (1.02%)  0/321 (0.00%) 
Oedema peripheral  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Sudden cardiac death  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  2/319 (0.63%)  0/98 (0.00%)  0/321 (0.00%) 
Cholecystitis acute  1  0/319 (0.00%)  1/98 (1.02%)  0/321 (0.00%) 
Cholelithiasis  1  1/319 (0.31%)  0/98 (0.00%)  1/321 (0.31%) 
Hepatitis  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Infections and infestations       
Bronchopneumonia  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Campylobacter gastroenteritis  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Cellulitis  1  0/319 (0.00%)  0/98 (0.00%)  2/321 (0.62%) 
Dengue fever  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Gangrene  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Pharyngitis  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Pneumonia  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Pneumonia primary atypical  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Post procedural infection  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Respiratory tract infection  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Sepsis  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Urinary tract infection  1  2/319 (0.63%)  0/98 (0.00%)  3/321 (0.93%) 
Injury, poisoning and procedural complications       
Clavicle fracture  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Fall  1  2/319 (0.63%)  0/98 (0.00%)  0/321 (0.00%) 
Humerus fracture  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Joint injury  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Limb injury  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Neck injury  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Pelvic fracture  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Pneumothorax traumatic  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Rib fracture  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Spinal fracture  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Subdural haematoma  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Traumatic lung injury  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Wound  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Metabolism and nutrition disorders       
Diabetes mellitus inadequate control  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Diabetic ketoacidosis  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Fluid overload  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Hyperglycaemia  1  0/319 (0.00%)  0/98 (0.00%)  2/321 (0.62%) 
Hypoglycaemia  1  0/319 (0.00%)  0/98 (0.00%)  3/321 (0.93%) 
Hypovolaemia  1  2/319 (0.63%)  0/98 (0.00%)  0/321 (0.00%) 
Metabolic disorder  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Back pain  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Osteoarthritis  1  0/319 (0.00%)  1/98 (1.02%)  1/321 (0.31%) 
Pain in extremity  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant melanoma  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Oesophageal carcinoma  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Oropharyngeal cancer stage unspecified  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Pancreatic carcinoma  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Prostate cancer metastatic  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Skin cancer  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Squamous cell carcinoma  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Squamous cell carcinoma of skin  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Nervous system disorders       
Aphasia  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Cerebral infarction  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Cerebrovascular accident  1  1/319 (0.31%)  0/98 (0.00%)  2/321 (0.62%) 
Dizziness  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Dysarthria  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Embolic cerebral infarction  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Hypoaesthesia  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Hypoxic-ischaemic encephalopathy  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Lacunar infarction  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Syncope  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Transient ischaemic attack  1  1/319 (0.31%)  0/98 (0.00%)  1/321 (0.31%) 
Psychiatric disorders       
Abnormal behaviour  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Depressive symptom  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Renal and urinary disorders       
Diabetic nephropathy  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Renal colic  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Renal failure  1  1/319 (0.31%)  0/98 (0.00%)  1/321 (0.31%) 
Renal failure acute  1  3/319 (0.94%)  0/98 (0.00%)  3/321 (0.93%) 
Renal failure chronic  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Renal impairment  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/319 (0.00%)  1/98 (1.02%)  0/321 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  2/319 (0.63%)  0/98 (0.00%)  0/321 (0.00%) 
Epistaxis  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Hypoxia  1  1/319 (0.31%)  0/98 (0.00%)  1/321 (0.31%) 
Pharyngeal oedema  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Pulmonary embolism  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Pulmonary oedema  1  2/319 (0.63%)  0/98 (0.00%)  0/321 (0.00%) 
Skin and subcutaneous tissue disorders       
Diabetic foot  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Vascular disorders       
Aortic stenosis  1  0/319 (0.00%)  1/98 (1.02%)  0/321 (0.00%) 
Circulatory collapse  1  2/319 (0.63%)  0/98 (0.00%)  0/321 (0.00%) 
Deep vein thrombosis  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Extremity necrosis  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Hypertension  1  2/319 (0.63%)  0/98 (0.00%)  0/321 (0.00%) 
Hypotension  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Intra-abdominal haematoma  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Lymphocele  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Peripheral ischaemia  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
Subclavian artery stenosis  1  1/319 (0.31%)  0/98 (0.00%)  0/321 (0.00%) 
Thrombophlebitis  1  0/319 (0.00%)  0/98 (0.00%)  1/321 (0.31%) 
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 Empa 10mg Empa 25mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   207/319 (64.89%)   64/98 (65.31%)   187/321 (58.26%) 
Infections and infestations       
Balanitis candida  1  0/319 (0.00%)  5/98 (5.10%)  0/321 (0.00%) 
Influenza  1  8/319 (2.51%)  6/98 (6.12%)  8/321 (2.49%) 
Nasopharyngitis  1  29/319 (9.09%)  6/98 (6.12%)  27/321 (8.41%) 
Upper respiratory tract infection  1  25/319 (7.84%)  14/98 (14.29%)  35/321 (10.90%) 
Urinary tract infection  1  39/319 (12.23%)  14/98 (14.29%)  38/321 (11.84%) 
Metabolism and nutrition disorders       
Hyperglycaemia  1  41/319 (12.85%)  4/98 (4.08%)  23/321 (7.17%) 
Hypoglycaemia  1  92/319 (28.84%)  27/98 (27.55%)  89/321 (27.73%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  21/319 (6.58%)  7/98 (7.14%)  13/321 (4.05%) 
Back pain  1  19/319 (5.96%)  8/98 (8.16%)  19/321 (5.92%) 
Pain in extremity  1  10/319 (3.13%)  8/98 (8.16%)  6/321 (1.87%) 
Nervous system disorders       
Headache  1  13/319 (4.08%)  5/98 (5.10%)  16/321 (4.98%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  25/319 (7.84%)  2/98 (2.04%)  11/321 (3.43%) 
Vascular disorders       
Hypertension  1  20/319 (6.27%)  1/98 (1.02%)  14/321 (4.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.0
In this trial, only patients with mild or moderate renal impairment were analysed. Patients with severe or no renal impairment were not analysed.
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: NCT01164501     History of Changes
Other Study ID Numbers: 1245.36
2009-016179-31 ( EudraCT Number: EudraCT )
First Submitted: July 15, 2010
First Posted: July 16, 2010
Results First Submitted: May 16, 2014
Results First Posted: June 16, 2014
Last Update Posted: June 16, 2014