At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy
In Brief
A Phase 3 clinical trial evaluating Omarigliptin, Sitagliptin, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 414 participants.
Detailed Summary
The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1) Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.
Study Details
Timeline
Interventions
Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly
Sitagliptin 50 mg tablet administered orally once daily
Placebo to omarigliptin 25 mg capsule administered orally once weekly
Placebo to sitagliptin 50 mg tablet administered orally once daily