Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.

Phase 3 Completed 305 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare pioglitazone and metformin combination therapy, twice daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects with dyslipidemia.

Timeline

Start: 2007-04
Primary completion: 2009-05
Completion: 2009-05

Outcome

Met primary endpoint

registry analysis (superiority or other test); Pioglitazone 15 mg and Metformin 850 mg BID vs Glimepiride 2 mg and Metformin 850 mg BID; p = 0.0018 NCT00770653 ↗

Publications

Pfutzner A, Schondorf T, Tschope D, Lobmann R, Merke J, Muller J, Lehmann U, Fuchs W, Forst T. PIOfix-study: effects of pioglitazone/metformin fixed combination in comparison with a combination of metformin with glimepiride on diabetic dyslipidemia. Diabetes Technol Ther. 2011 Jun;13(6):637-43. doi: 10.1089/dia.2010.0233. Epub 2011 Apr 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Glimepiride	Small molecule	2 mg	Oral
Subject	Pioglitazone	Small molecule	15 mg	Oral
Background	Metformin	Small molecule	850 mg	Oral