Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.

Phase 3 Completed 71 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.

Timeline

Start: 2007-07
Primary completion: 2009-12
Completion: 2009-12

Outcome

Met primary endpoint

registry Placebo QD vs Alogliptin 25 mg QD; p <0.001; Mean Difference (Final Values) -307.229 (95% CI -443.168 to -171.290) NCT00655863 ↗

paper produced similar significant reductions in total postprandial TG response (incremental AUC [iAUC]; p < 0.001) PMID 22237690 ↗

Publications

Results Eliasson B, Moller-Goede D, Eeg-Olofsson K, Wilson C, Cederholm J, Fleck P, Diamant M, Taskinen MR, Smith U. Lowering of postprandial lipids in individuals with type 2 diabetes treated with alogliptin and/or pioglitazone: a randomised double-blind placebo-controlled study. Diabetologia. 2012 Apr;55(4):915-25. doi: 10.1007/s00125-011-2447-3. Epub 2012 Jan 12.

Drugs

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