Efficacy of Alogliptin and Pioglitazone in Subjects With Type 2 Diabetes Mellitus

Phase 3 Completed 803 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to compare the effect of adding alogliptin, once daily (QD), to the ongoing treatment regimen of pioglitazone HCl and metformin in patients with inadequate glycemic control.

Timeline

Start: 2007-01
Primary completion: 2009-05
Completion: 2009-06

Outcome

Met primary endpoint

paper Met+Pio30+Alo25 showed superior glycaemic control versus Met+Pio45 at week 52 [least squares (LS) mean CFB in A1c, -0.70 vs. -0.29%; p < 0.001]. PMID 21733058 ↗

Publications

Results Bosi E, Ellis GC, Wilson CA, Fleck PR. Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week, randomized, double-blind, active-controlled, parallel-group study. Diabetes Obes Metab. 2011 Dec;13(12):1088-96. doi: 10.1111/j.1463-1326.2011.01463.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alogliptin	Unknown	25 mg	Oral
Subject	Pioglitazone	Small molecule	30 mg	Oral
Subject	Pioglitazone	Small molecule	45 mg	Oral
Background	Metformin	Small molecule	1500 mg	Oral