Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

Summary

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.

Timeline

Start

2006-04

Primary completion

2007-08

Completion

—

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Linagliptin 10 mg; p <0.0001; Mean Difference (Final Values) -0.67 (95% CI -0.95 to -0.39) NCT00309608 ↗

Drugs

Indications