Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
Completed
Boehringer Ingelheim
Phase 2
2006-04-01
The objective of the study is to test the efficacy, safety and tolerability of several doses
of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks
together with metformin in patients with type 2 diabetes mellitus who are not at goal with
their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as
add-on therapy to metformin for comparison. The influence of several factors (gender, age,
weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in
this study.
Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
Completed
Boehringer Ingelheim
Phase 3
2008-01-01
The objective of the current study is to investigate the efficacy, safety and tolerability of
BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to
metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes
Completed
Boehringer Ingelheim
Phase 3
2008-02-01
The objective of the current study is to investigate the efficacy, safety and tolerability of
BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to
metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with
insufficient glycaemic control.
Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
Completed
Boehringer Ingelheim
Phase 3
2008-12-01
The objective of the randomised part of the study is to investigate the efficacy and safety
of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug
naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic
patients with insufficient glycaemic control. For the open-label part of the study the
objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic
patients with very poor glycaemic control for 24 weeks
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