Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 414
Healthy volunteers: no

Brief 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.

Detailed description:
The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). Participants will receive in Phase A: omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo and in Phase B: omarigliptin 25 mg once weekly.

Arms:
arm 1: Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B) arm 2: Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B) arm 3: Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

Interventions: intervention 1: Omarigliptin intervention 2: Sitagliptin intervention 3: Placebo to omarigliptin intervention 4: Placebo to sitagliptin
Intervention descriptions: intervention 1: Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly intervention 2: Sitagliptin 50 mg tablet administered orally once daily intervention 3: Placebo to omarigliptin 25 mg capsule administered orally once weekly intervention 4: Placebo to sitagliptin 50 mg tablet administered orally once daily

Protocol document: