MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

Phase 3 Completed 517 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Timeline

Start: 2008-01-26
Primary completion: 2009-10-23
Completion: 2009-10-23

Outcome

Met primary endpoint

paper LS mean changes in HbA1c at week 32 were -1.9 and -1.4% for sitagliptin/metformin and pioglitazone, respectively (between-group difference = -0.5%; p < 0.001). PMID 22059736 ↗

Publications

Results Wainstein J, Katz L, Engel SS, Xu L, Golm GT, Hussain S, O'Neill EA, Kaufman KD, Goldstein BJ. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2012 May;14(5):409-18. doi: 10.1111/j.1463-1326.2011.01530.x. Epub 2011 Dec 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	1000 mg	—
Comparator	Pioglitazone	Small molecule	45 mg	—
Subject	Sitagliptin	Small molecule	50 mg	—