Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone

Phase 3 Completed 389 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Timeline

Start: 2008-03
Primary completion: 2009-06
Completion: —

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo + Pioglitazone vs Linagliptin + Pioglitazone; p <0.0001; Mean Difference (Final Values) -0.51 (95% CI -0.71 to -0.30); ANCOVA NCT00641043 ↗

Publications

Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Linagliptin	Unknown	5 mg	Oral
Background	Pioglitazone	Small molecule	30 mg	Oral