At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
In Brief
A Phase 3 clinical trial evaluating Sitagliptin, Comparator: Rosiglitazone, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 273 participants.
Detailed Summary
The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.
Study Details
Timeline
Interventions
Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.
Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.
placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.
Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of \>= 1500 mg.