Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01167881
First received: July 15, 2010
Last updated: July 17, 2014
Last verified: July 2014
Results First Received: July 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: BI 10773
Drug: Glimepiride
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Empaglifozin 25 mg

Patients receive one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule once daily

Empagliflozin: 25 mg once daily

Placebo: Placebo matching Glimepiride

Glimepiride

Patients receive one Glimepiride capsule and one placebo Empagliflozin tablet once daily.

Glimepiride: 1-4 mg once daily

Placebo: Placebo matching Empagliflozin


Participant Flow:   Overall Study
    Empaglifozin 25 mg     Glimepiride  
STARTED     769     780  
COMPLETED     676     686  
NOT COMPLETED     93     94  
Not treated                 4                 0  
Lost to Follow-up                 19                 19  
Withdrawal by Subject                 57                 62  
Death                 4                 4  
Reason not defined above                 9                 9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), All patients randomised, treated with at least one dose of study drug, and with a baseline HbA1c value.

Reporting Groups
  Description
Empaglifozin 25 mg

Patients receive one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule once daily

Empagliflozin: 25 mg once daily

Placebo: Placebo matching Glimepiride

Glimepiride

Patients receive one Glimepiride capsule and one placebo Empagliflozin tablet once daily.

Glimepiride: 1-4 mg once daily

Placebo: Placebo matching Empagliflozin

Total Total of all reporting groups

Baseline Measures
    Empaglifozin 25 mg     Glimepiride     Total  
Number of Participants  
[units: participants]
  765     780     1545  
Age  
[units: years]
Mean ± Standard Deviation
  56.2  ± 10.3     55.7  ± 10.4     55.9  ± 10.4  
Gender  
[units: participants]
     
Female     333     359     692  
Male     432     421     853  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.   [ Time Frame: Baseline and 104 weeks ]

2.  Secondary:   The Change in Body Weight From Baseline After 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

3.  Secondary:   The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

4.  Secondary:   The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

5.  Secondary:   The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

6.  Secondary:   The Change From Baseline in HbA1c After 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]

7.  Secondary:   The Change in Body Weight From Baseline After 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]

8.  Secondary:   The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]

9.  Secondary:   The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]

10.  Secondary:   The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]


  Serious Adverse Events
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Time Frame Up to 104 weeks
Additional Description All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.

Reporting Groups
  Description
Empaglifozin 25 mg

Patients receive one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule once daily

Empagliflozin: 25 mg once daily

Placebo: Placebo matching Glimepiride

Glimepiride

Patients receive one Glimepiride capsule and one placebo Empagliflozin tablet once daily.

Glimepiride: 1-4 mg once daily

Placebo: Placebo matching Empagliflozin


Serious Adverse Events
    Empaglifozin 25 mg     Glimepiride  
Total, serious adverse events      
# participants affected / at risk     119/765 (15.56%)     89/780 (11.41%)  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     0/765 (0.00%)     2/780 (0.26%)  
Iron deficiency anaemia † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Thrombocytopenia † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Cardiac disorders      
Acute myocardial infarction † 1    
# participants affected / at risk     1/765 (0.13%)     6/780 (0.77%)  
Coronary artery disease † 1    
# participants affected / at risk     2/765 (0.26%)     6/780 (0.77%)  
Myocardial ischaemia † 1    
# participants affected / at risk     0/765 (0.00%)     3/780 (0.38%)  
Angina unstable † 1    
# participants affected / at risk     2/765 (0.26%)     2/780 (0.26%)  
Atrial fibrillation † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Cardiac failure † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Angina pectoris † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Cardiac disorder † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Cardiac failure congestive † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Cardiac tamponade † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Myocardial infarction † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Palpitations † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Tachycardia † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Ventricle rupture † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Congenital, familial and genetic disorders      
Phimosis † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Ear and labyrinth disorders      
Otosclerosis † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Tinnitus † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Endocrine disorders      
Goitre † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Eye disorders      
Retinal detachment † 1    
# participants affected / at risk     1/765 (0.13%)     2/780 (0.26%)  
Cataract † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Diabetic retinopathy † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Open angle glaucoma † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Retinal neovascularisation † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Vitreous haemorrhage † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Gastrointestinal disorders      
Gastrointestinal haemorrhage † 1    
# participants affected / at risk     3/765 (0.39%)     0/780 (0.00%)  
Inguinal hernia † 1    
# participants affected / at risk     3/765 (0.39%)     0/780 (0.00%)  
Abdominal pain † 1    
# participants affected / at risk     2/765 (0.26%)     2/780 (0.26%)  
Abdominal pain upper † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Vomiting † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Abdominal hernia † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Anorectal varices † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Anorectal varices haemorrhage † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Colitis † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Diverticulum intestinal † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Dyspepsia † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Enterocolitis haemorrhagic † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Gastric ulcer † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Gastritis † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Haemorrhoids † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Hiatus hernia † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Impaired gastric emptying † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Inguinal hernia, obstructive † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Large intestine polyp † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Oesophageal varices haemorrhage † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Pancreatitis † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Pancreatitis acute † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Proctitis haemorrhagic † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Rectal polyp † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Umbilical hernia † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Volvulus † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
General disorders      
Chest pain † 1    
# participants affected / at risk     1/765 (0.13%)     3/780 (0.38%)  
Non-cardiac chest pain † 1    
# participants affected / at risk     1/765 (0.13%)     2/780 (0.26%)  
Cyst † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Multi-organ failure † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Pain † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Pyrexia † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Sudden death † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Hepatobiliary disorders      
Cholelithiasis † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Cholangitis acute † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Cholecystitis acute † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Cholecystitis chronic † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Drug-induced liver injury † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Hepatic cirrhosis † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Hepatic failure † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Liver disorder † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Portal hypertension † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Immune system disorders      
Drug hypersensitivity † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Infections and infestations      
Viral infection † 1    
# participants affected / at risk     3/765 (0.39%)     0/780 (0.00%)  
Cellulitis † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Diverticulitis † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Pneumonia † 1    
# participants affected / at risk     1/765 (0.13%)     2/780 (0.26%)  
Post procedural infection † 1    
# participants affected / at risk     0/765 (0.00%)     2/780 (0.26%)  
Abscess limb † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Appendicitis † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Bronchitis † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Cystitis escherichia † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Diarrhoea infectious † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Erysipelas † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Escherichia bacteraemia † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Febrile infection † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Gastroenteritis † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Gastroenteritis salmonella † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Hepatitis E † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Infectious mononucleosis † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Kidney infection † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Lung infection † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Nasopharyngitis † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Peritonitis bacterial † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Pyelonephritis acute † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Sepsis † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Septic shock † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Sialoadenitis † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Upper respiratory tract infection † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Injury, poisoning and procedural complications      
Fall † 1    
# participants affected / at risk     6/765 (0.78%)     1/780 (0.13%)  
Fibula fracture † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Incisional hernia † 1    
# participants affected / at risk     0/765 (0.00%)     2/780 (0.26%)  
Road traffic accident † 1    
# participants affected / at risk     0/765 (0.00%)     2/780 (0.26%)  
Tibia fracture † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Traumatic fracture † 1    
# participants affected / at risk     2/765 (0.26%)     1/780 (0.13%)  
Ankle fracture † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Femur fracture † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Foreign body † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Head injury † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Humerus fracture † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Joint dislocation † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Ligament sprain † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Meniscus injury † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Muscle rupture † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Overdose † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Post procedural constipation † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Post procedural haemorrhage † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Procedural headache † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Radius fracture † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Soft tissue injury † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Subdural haematoma † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Diabetes mellitus inadequate control † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Electrolyte imbalance † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Fluid overload † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Hypokalaemia † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Obesity † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Musculoskeletal and connective tissue disorders      
Back pain † 1    
# participants affected / at risk     2/765 (0.26%)     1/780 (0.13%)  
Foot deformity † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Intervertebral disc protrusion † 1    
# participants affected / at risk     0/765 (0.00%)     2/780 (0.26%)  
Osteoarthritis † 1    
# participants affected / at risk     2/765 (0.26%)     2/780 (0.26%)  
Spinal osteoarthritis † 1    
# participants affected / at risk     2/765 (0.26%)     2/780 (0.26%)  
Arthralgia † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Cervical spinal stenosis † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Chondrocalcinosis pyrophosphate † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Intervertebral disc disorder † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Lumbar spinal stenosis † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Musculoskeletal pain † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Neck pain † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Synovitis † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Tendonitis † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Basal cell carcinoma † 1    
# participants affected / at risk     2/765 (0.26%)     1/780 (0.13%)  
Breast cancer † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Prostate cancer † 1    
# participants affected / at risk     2/765 (0.26%)     2/780 (0.26%)  
Rectal cancer † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Acute myeloid leukaemia † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Adenocarcinoma pancreas † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Colon cancer † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Hepatic cancer † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Laryngeal squamous cell carcinoma † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Lung adenocarcinoma stage IV † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Malignant melanoma in situ † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Malignant pleural effusion † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Meningioma † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Metastases to bone † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Metastases to liver † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Nasal neoplasm † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Pancreatic carcinoma † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Pericardial effusion malignant † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Renal cell carcinoma † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Squamous cell carcinoma † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Transitional cell carcinoma † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Uterine leiomyoma † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Nervous system disorders      
Cerebrovascular accident † 1    
# participants affected / at risk     5/765 (0.65%)     1/780 (0.13%)  
Carpal tunnel syndrome † 1    
# participants affected / at risk     1/765 (0.13%)     2/780 (0.26%)  
Cerebral haemorrhage † 1    
# participants affected / at risk     0/765 (0.00%)     2/780 (0.26%)  
Dizziness † 1    
# participants affected / at risk     2/765 (0.26%)     0/780 (0.00%)  
Ischaemic stroke † 1    
# participants affected / at risk     2/765 (0.26%)     1/780 (0.13%)  
Brain stem infarction † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Carotid artery stenosis † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Cerebrovascular disorder † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Convulsion † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Headache † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Lacunar infarction † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Myelopathy † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Optic neuritis † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Radicular pain † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Subarachnoid haemorrhage † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Syncope † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Transient ischaemic attack † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Trigeminal neuralgia † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Psychiatric disorders      
Delusional disorder, unspecified type † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Mental disorder † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Suicide attempt † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Renal and urinary disorders      
Bladder prolapse † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Haematuria † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Nephrolithiasis † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Renal cyst † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Renal failure † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Renal failure acute † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Urinary tract obstruction † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Reproductive system and breast disorders      
Benign prostatic hyperplasia † 1    
# participants affected / at risk     3/765 (0.39%)     1/780 (0.13%)  
Balanoposthitis † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Dysfunctional uterine bleeding † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Endometrial hyperplasia † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Menorrhagia † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Metrorrhagia † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Prostatism † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Dyspnoea † 1    
# participants affected / at risk     2/765 (0.26%)     1/780 (0.13%)  
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Dysphonia † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Lung consolidation † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Paranasal cyst † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Pleural effusion † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Pneumothorax † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Skin and subcutaneous tissue disorders      
Diabetic foot † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Surgical and medical procedures      
Hip arthroplasty † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Hysterectomy † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Knee arthroplasty † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Omentectomy † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Oophorectomy bilateral † 1    
# participants affected / at risk     1/765 (0.13%)     0/780 (0.00%)  
Vascular disorders      
Deep vein thrombosis † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Hypertension † 1    
# participants affected / at risk     1/765 (0.13%)     1/780 (0.13%)  
Peripheral arterial occlusive disease † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Thrombophlebitis † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Varicose vein † 1    
# participants affected / at risk     0/765 (0.00%)     1/780 (0.13%)  
Events were collected by systematic assessment
1 Term from vocabulary, MEDDRA 16.0




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01167881     History of Changes
Other Study ID Numbers: 1245.28, 2009-016244-39
Study First Received: July 15, 2010
Results First Received: July 17, 2014
Last Updated: July 17, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Medicines and Medical Devices Agency
Canada: Health Canada
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Hong Kong: Department of Health
India: Drugs Controller General of India
Italy: Ethics Committee
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Philippines: Bureau of Food and Drugs
Portugal: National Pharmacy and Medicines Institute
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan : Food and Drug Administration
Thailand: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration