Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

Phase 3 Completed 190 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.

Timeline

Start: 2006-06
Primary completion: 2007-05
Completion: 2007-08

Outcome

Met primary endpoint

registry Sitagliptin 100 mg vs Placebo; p <0.001; Mean Difference (Net) -1.02 (95% CI -1.36 to -0.67); ANCOVA NCT00337610 ↗

Publications

Background Raz I, Chen Y, Wu M, Hussain S, Kaufman KD, Amatruda JM, Langdon RB, Stein PP, Alba M. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008 Feb;24(2):537-50. doi: 10.1185/030079908x260925.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	100 mg	Oral
Background	Metformin	Small molecule	1500 mg	Oral