Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

Summary

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

Timeline

Start

2008-01

Primary completion

2009-05

Completion

—

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Linagliptin; p <0.0001; Least Squares Mean Difference -0.64 (95% CI -0.78 to -0.5); ANCOVA NCT00601250 ↗

Publications

• Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.

Drugs

Indications