BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
NCT01131676 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7064
Last updated 2016-05-16
Summary
The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
BI 10773 low dose
BI 10773 tablets once daily
- DRUG
-
Placebo BI 10773 high dose
Placebo tablets identical to BI 10773
- DRUG
-
BI 10773 high dose
BI 10773 tablets once daily
- DRUG
-
Placebo BI 10773 low dose
Placebo tablets identical to BI 10773
- DRUG
-
Placebo BI 10773 low dose
Placebo tablets identical to BI 10773
- DRUG
-
Placebo BI 10773 high dose
Placebo tablets identical to BI 10773
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2015-04-30
- Completion
- 2015-04-30
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- Colombia
- Croatia
- Czechia
- Denmark
- Estonia
- France
- Georgia
- Greece
- Hong Kong
- Hungary
- India
- Indonesia
- Israel
- Italy
- Japan
- Malaysia
- Mexico
- Netherlands
- New Zealand
- Norway
- Peru
- Philippines
- Poland
- Portugal
- Romania
- Russia
- Singapore
- South Africa
- South Korea
- Spain
- Sri Lanka
- Taiwan
- Thailand
- Ukraine
- United Kingdom
Study Locations
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