Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
NCT01289990 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2705
Last updated 2014-07-15
Summary
This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
BI 10773
BI 10773 tablets once daily
- DRUG
-
Placebo matching BI 10773 low dose
- DRUG
-
Placebo matching BI 10773 high dose
- DRUG
-
Placebo matching Sitagliptin
- DRUG
-
Placebo matching BI 10773 high dose
- DRUG
-
Placebo matching BI 10773 high dose
- DRUG
-
BI 10773
BI 10773 tablets once daily
- DRUG
-
Placebo matching BI 10773 low dose
- DRUG
-
Placebo matching BI 10773 low dose
- DRUG
-
BI 10773
BI 10773 tablets once daily
- DRUG
-
Placebo matching BI 10773 low dose
- DRUG
-
Placebo matching BI 10773 high dose
- DRUG
-
Placebo matching Sitagliptin
- DRUG
-
BI 10773
BI 10773 tablets once daily
- DRUG
-
BI 10773
BI 10773 tablets once daily
- DRUG
-
BI 10773
BI 10773 tablets once daily
- DRUG
-
Placebo matching BI 10773 high dose
- DRUG
-
BI 10773
BI 10773 tablets once daily
- DRUG
-
Placebo matching BI 10773 low dose
- DRUG
-
Placebo matching BI 10773 high dose
- DRUG
-
Placebo matching Sitagliptin
- DRUG
-
Sitagliptin 100mg
Sitagliptin once daily
- DRUG
-
BI 10773
BI 10773 tablets once daily
- DRUG
-
Placebo matching BI 10773 low dose
- DRUG
-
Placebo matching BI 10773 low dose
- DRUG
-
Placebo matching BI 10773 low dose
- DRUG
-
Placebo matching BI 10773 high dose
- DRUG
-
Placebo matching BI 10773 low dose
- DRUG
-
Placebo matching BI 10773 high dose
- DRUG
-
Placebo matching BI 10773 high dose
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-02-28
- Primary Completion
- 2013-05-31
- Completion
- 2013-05-31
Countries
- United States
- Belgium
- Canada
- China
- France
- Germany
- Greece
- India
- Ireland
- Japan
- Mexico
- Philippines
- Slovakia
- Slovenia
- South Korea
- Switzerland
- Taiwan
- Turkey (Türkiye)
- Ukraine
Study Locations
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