Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes

Phase 3 Completed 784 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.

Timeline

Start: 2009-11
Primary completion: 2011-06
Completion: 2011-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); Alogliptin 12.5 BID vs Alogliptin 12.5 BID + Metformin 500 BID; p <0.001; LS mean difference -0.67 NCT01023581 ↗

registry analysis (superiority or other test); Metformin 500 BID vs Alogliptin 12.5 BID + Metformin 500 BID; p <0.001; LS mean difference -0.57 NCT01023581 ↗

registry analysis (superiority or other test); Alogliptin 12.5 BID vs Alogliptin 12.5 BID + Metformin 1000 BID; p <0.001; LS mean difference -1.00 NCT01023581 ↗

registry analysis (superiority or other test); Metformin 1000 BID vs Alogliptin 12.5 BID + Metformin 1000 BID; p <0.001; LS mean difference -0.44 NCT01023581 ↗

Publications

Pratley RE, Fleck P, Wilson C. Efficacy and safety of initial combination therapy with alogliptin plus metformin versus either as monotherapy in drug-naive patients with type 2 diabetes: a randomized, double-blind, 6-month study. Diabetes Obes Metab. 2014 Jul;16(7):613-21. doi: 10.1111/dom.12258. Epub 2014 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alogliptin	Unknown	12.5 mg	Oral
Subject	Alogliptin	Unknown	25 mg	Oral
Subject	Metformin	Small molecule	500 mg	Oral
Subject	Metformin	Small molecule	1000 mg	Oral