Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
NCT01422876 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1405
Last updated 2015-04-02
Summary
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
high dose FDC
once daily
- DRUG
-
BI 10773 high dose
once daily
- DRUG
-
high dose FDC placebo
once daily
- DRUG
-
low dose FDC placebo
once daily
- DRUG
-
high dose FDC placebo
once daily
- DRUG
-
high dose FDC placebo
once daily
- DRUG
-
low dose FDC placebo
once daily
- DRUG
-
low dose FDC placebo
once daily
- DRUG
-
high dose BI 10773 placebo
once daily
- DRUG
-
low dose FDC
once daily
- DRUG
-
high dose FDC placebo
once daily
- DRUG
-
BI 10773 low dose
low dose once daily
- DRUG
-
high dose BI 10773 placebo
once daily
- DRUG
-
high dose BI 10773 placebo
once daily
- DRUG
-
linagliptin
once daily
- DRUG
-
low dose FDC placebo
once daily
- DRUG
-
linagliptin placebo
once daily
- DRUG
-
BI 10773 low dose placebo
once daily
- DRUG
-
linagliptin placebo
once daily
- DRUG
-
low dose BI 10773 placebo
once daily
- DRUG
-
linagliptin placebo
once daily
- DRUG
-
high dose BI 10773 placebo
once daily
- DRUG
-
BI 10773 low dose placebo
once daily
- DRUG
-
low dose BI 10773 placebo
once daily
- DRUG
-
linagliptin placebo
once daily
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
- 2011-08-31
- Primary Completion
- 2013-09-30
- Completion
- 2013-09-30
Countries
- United States
- Argentina
- Australia
- Brazil
- Bulgaria
- Canada
- Colombia
- Denmark
- Estonia
- Hungary
- Italy
- Lebanon
- Malaysia
- Mexico
- Peru
- Philippines
- Poland
- Romania
- Russia
- Spain
- Sweden
- Taiwan
Study Locations
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