Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus

Phase 3 Completed 655 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with diet and exercise alone.

Timeline

Start: 2006-11
Primary completion: 2008-02
Completion: 2008-02

Outcome

Met primary endpoint

paper Combination therapy with A25+P30 resulted in greater reductions in A1C (-1.7±0.1% from an 8.8% mean baseline) vs. A25 (-1.0±0.1%, P<0.001) PMID 20724648 ↗

registry analysis (superiority or other test); Pioglitazone 30 mg vs Alogliptin 25 mg + Pioglitazone 30 mg; p <0.001; LS Mean Difference -0.56 (95% CI -0.78 to -0.33); NCT00395512 ↗

registry analysis (superiority or other test); Alogliptin 25 mg vs Alogliptin 25 mg + Pioglitazone 30 mg; p <0.001; LS Mean Difference -0.75 (95% CI -0.98 to -0.53); NCT00395512 ↗

registry analysis (superiority or other test); Pioglitazone 30 mg vs Alogliptin 12.5 mg + Pioglitazone 30 mg; p <0.001; LS Mean Difference -0.40 (95% CI -0.63 to -0.18); NCT00395512 ↗

Publications

Results Rosenstock J, Inzucchi SE, Seufert J, Fleck PR, Wilson CA, Mekki Q. Initial combination therapy with alogliptin and pioglitazone in drug-naive patients with type 2 diabetes. Diabetes Care. 2010 Nov;33(11):2406-8. doi: 10.2337/dc10-0159. Epub 2010 Aug 19.

Drugs

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