Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

Summary

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

Timeline

Start

2009-11

Primary completion

2010-09

Completion

—

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Lina 2.5 Twice Daily (Bid); p <0.0001; Mean Difference (Final Values) -0.74 (95% CI -0.97 to -0.52); ANCOVA NCT01012037 ↗

paper The upper bound of which was less than the predefined noninferiority margin (0.35%). PMID 22816729 ↗

Publications

• Ross SA, Rafeiro E, Meinicke T, Toorawa R, Weber-Born S, Woerle HJ. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial. Curr Med Res Opin. 2012 Sep;28(9):1465-74. doi: 10.1185/03007995.2012.714360. Epub 2012 Aug 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Linagliptin	Unknown	2.5 mg	Oral
Subject	Linagliptin	Unknown	5 mg	Oral

Indications