Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
NCT01778049 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 708
Last updated 2016-04-04
Summary
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
BI 10773
Empagliflozin active
- DRUG
-
BI 10773 Placebo
Empagliflozin placebo
- DRUG
-
BI 10773 / BI 1356
Empagliflozin / Linagliptin 25/5 mg Dose FDC active
- DRUG
-
BI 10773
Empagliflozin active
- DRUG
-
BI 10773 / BI 1356
Empagliflozin / Linagliptin 10/5 mg Dose FDC active
- DRUG
-
BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC
- DRUG
-
BI 10773
Empagliflozin active
- DRUG
-
BI 10773
Empagliflozin active
- DRUG
-
BI 10773
Empagliflozin active
- DRUG
-
BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
- DRUG
-
BI 10773 Placebo
Empagliflozin placebo
- DRUG
-
BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
- DRUG
-
BI 10773
Empagliflozin active
- DRUG
-
BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
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
- 2013-01-31
- Primary Completion
- 2015-03-31
- Completion
- 2015-03-31
Countries
- United States
- Argentina
- Australia
- Canada
- El Salvador
- Germany
- Italy
- Portugal
- Russia
- Spain
- Ukraine
Study Locations
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