At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin
In Brief
A Phase 3 clinical trial evaluating Omarigliptin, Matching placebo to Omarigliptin, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 307 participants.
Detailed Summary
This study will examine the safety and efficacy of the addition of omarigliptin in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo.
Study Details
Timeline
Interventions
Omarigliptin 25 mg capsule administered orally once a week
Matching placebo to omarigliptin capsule administered orally once a week
Open-label glimepiride tablet(s) administered orally once daily for a total daily dose \>=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.
Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose \>=1500 mg