MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)

NCT00372060 ↗

Phase 3 Completed 134 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.

Timeline

Start: 2006-08-21
Primary completion: 2008-02-05
Completion: 2008-02-05

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sitagliptin / Sitagliptin vs Placebo / Sitagliptin; p <0.001; Least-squares Mean Difference -0.8 (95% CI -1.0 to -0.6); ANCOVA NCT00372060 ↗

Publications

Background Kashiwagi A, Kadowaki T, Tajima N, Nonaka K, Taniguchi T, Nishii M, Ferreira JC, Amatruda JM. Sitagliptin added to treatment with ongoing pioglitazone for up to 52 weeks improves glycemic control in Japanese patients with type 2 diabetes. J Diabetes Investig. 2011 Oct 7;2(5):381-90. doi: 10.1111/j.2040-1124.2011.00120.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	50 mg	—
Subject	Sitagliptin	Small molecule	100 mg	—
Background	Pioglitazone	Small molecule	—	—