A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)

Phase 3 Completed 427 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.

Timeline

Start: 2010-06-03
Primary completion: 2011-07-11
Completion: 2012-01-19

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sitagliptin vs Placebo/Pioglitazone; p <0.001; Difference in Least Squares Means -0.68 (95% CI -0.87 to -0.50); ANCOVA NCT01076075 ↗

paper At Week 24, significantly greater (P < 0.001) mean reductions from baseline were seen in the sitagliptin versus placebo group for HbA1c (-0.84% vs -0.16%, respectively) PMID 26625270 ↗

Publications

Results Moses RG, Round E, Shentu Y, Golm GT, O'neill EA, Gantz I, Engel SS, Kaufman KD, Goldstein BJ. A randomized clinical trial evaluating the safety and efficacy of sitagliptin added to the combination of sulfonylurea and metformin in patients with type 2 diabetes mellitus and inadequate glycemic control. J Diabetes. 2016 Sep;8(5):701-11. doi: 10.1111/1753-0407.12351. Epub 2016 Feb 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Pioglitazone	Small molecule	30 mg	—
Subject	Sitagliptin	Small molecule	100 mg	—
Background	Gliclazide	Small molecule	—	—
Background	Glimepiride	Small molecule	—	—
Background	Metformin	Small molecule	—	—
Background	Pioglitazone	Small molecule	30 mg	—