Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.

Phase 3 Completed 1554 enrolled Takeda

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2006-05
Primary completion: 2008-03
Completion: 2008-03

Outcome

Met primary endpoint

registry Pioglitazone Alone vs Alogliptin 12.5 + Pioglitazone; p <0.001; LS Mean Difference -0.54 (95% CI -0.67 to -0.41) NCT00328627 ↗

registry Pioglitazone Alone vs Alogliptin 25 + Pioglitazone; p <0.001; LS Mean Difference -0.53 (95% CI -0.66 to -0.41) NCT00328627 ↗

paper and -1.4 ± 0.05% in both the A12.5+P and A25+P groups (P < 0.001 for both comparisons). PMID 22419732 ↗

Publications

Results DeFronzo RA, Burant CF, Fleck P, Wilson C, Mekki Q, Pratley RE. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 May;97(5):1615-22. doi: 10.1210/jc.2011-2243. Epub 2012 Mar 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alogliptin	Unknown	12.5 mg	Oral
Subject	Alogliptin	Unknown	25 mg	Oral
Subject	Pioglitazone	Small molecule	15 mg	Oral
Subject	Pioglitazone	Small molecule	30 mg	Oral
Subject	Pioglitazone	Small molecule	45 mg	Oral