At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
In Brief
A Phase 3 clinical trial evaluating Omarigliptin, Sitagliptin, and 4 other interventions for Type 2 Diabetes. Completed, enrolled 642 participants.
Detailed Summary
This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.
Study Details
Timeline
Interventions
Omarigliptin (MK-3102) 25 mg oral capsule once a week for 24 weeks
Sitagliptin 100 mg oral tablet once a day for 24 weeks
Placebo to omarigliptin 25 mg oral capsule once a week for 24 weeks
Placebo to sitagliptin 100 mg oral tablet once a day for 24 weeks
Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day
Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy