Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)

Phase 3 Completed 313 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin.

Timeline

Start: 2009-04-15
Primary completion: 2010-11-10
Completion: 2010-11-10

Publications

Fonseca V, Staels B, Morgan JD 2nd, Shentu Y, Golm GT, Johnson-Levonas AO, Kaufman KD, Goldstein BJ, Steinberg H. Efficacy and safety of sitagliptin added to ongoing metformin and pioglitazone combination therapy in a randomized, placebo-controlled, 26-week trial in patients with type 2 diabetes. J Diabetes Complications. 2013 Mar-Apr;27(2):177-83. doi: 10.1016/j.jdiacomp.2012.09.007. Epub 2012 Oct 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	100 mg	Oral
Background	Glipizide	Small molecule	—	Oral
Background	Metformin	Small molecule	1500 mg	Oral
Background	Pioglitazone	Small molecule	30 mg	Oral

Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)

Summary

Timeline

Publications

Drugs

Indications