MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

Phase 3 Completed 1615 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.

Timeline

Start: 2008-09-05
Primary completion: 2010-10-26
Completion: 2011-03-25

Publications

Results Henry RR, Staels B, Fonseca VA, Chou MZ, Teng R, Golm GT, Langdon RB, Kaufman KD, Steinberg H, Goldstein BJ. Efficacy and safety of initial combination treatment with sitagliptin and pioglitazone--a factorial study. Diabetes Obes Metab. 2014 Mar;16(3):223-30. doi: 10.1111/dom.12194. Epub 2013 Aug 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pioglitazone	Small molecule	15 mg	Oral
Subject	Pioglitazone	Small molecule	30 mg	Oral
Subject	Pioglitazone	Small molecule	45 mg	Oral
Subject	Sitagliptin	Small molecule	100 mg	Oral
Background	Metformin	Small molecule	500 mg	Oral

MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

Summary

Timeline

Publications

Drugs

Indications