Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus

Summary

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with metformin in adults with type 2 diabetes mellitus.

Timeline

Start

2006-03

Primary completion

2007-06

Completion

2007-06

Outcome

Met primary endpoint

registry Alogliptin 12.5 mg QD vs Placebo; p <0.001; Mean Difference (Final Values) -0.50 (95% CI -0.68 to -0.32) NCT00286442 ↗

registry Alogliptin 25 mg QD vs Placebo; p <0.001; Mean Difference (Final Values) -0.48 (95% CI -0.67 to -0.30) NCT00286442 ↗

Publications

• Results Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 008 Group. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract. 2009 Jan;63(1):46-55. doi: 10.1111/j.1742-1241.2008.01933.x.
• Results Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alogliptin	Unknown	12.5 mg	Oral
Subject	Alogliptin	Unknown	25 mg	Oral
Background	Metformin	Small molecule	—	—

Indications