Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control

Summary

To investigate efficacy, safety and tolerability of BI 1356 versus placebo

Timeline

Start

2008-02

Primary completion

2009-05

Completion

—

Outcome

Met primary endpoint

registry MEAN Placebo: 0.25 (Standard Error 0.07) Percent MEAN Linagliptin: -0.44 (Standard Error 0.05) Percent NCT00621140 ↗

registry analysis (superiority or other test); Placebo vs Linagliptin; p <0.0001; Mean Difference (Final Values) -0.69 (95% CI -0.85 to -0.53); ANCOVA NCT00621140 ↗

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.
• 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

Indications