Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan

Phase 2/3 Completed 230 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an α-glucosidase inhibitor taken three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.

Timeline

Start: 2007-01
Primary completion: 2008-04
Completion: 2008-04

Outcome

Met primary endpoint

paper (primary endpoint) was significantly greater in the alogliptin 12.5 mg (-0.96%; P < 0.0001) PMID 22106975 ↗

paper and 25 mg (-0.93%; P < 0.0001) groups compared with placebo (+0.06%). PMID 22106975 ↗

Publications

Seino Y, Fujita T, Hiroi S, Hirayama M, Kaku K. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension. Curr Med Res Opin. 2011 Nov;27 Suppl 3:21-9. doi: 10.1185/03007995.2011.614936.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alogliptin	Unknown	12.5 mg	Oral
Subject	Alogliptin	Unknown	25 mg	Oral
Background	Voglibose	Small molecule	0.2 mg	Oral