Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 307
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Omarigliptin (MK-3102) 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \>=1500 mg per day). arm 2: Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \>=1500 mg per day).

Interventions: intervention 1: Omarigliptin intervention 2: Matching placebo to Omarigliptin intervention 3: Glimepiride intervention 4: Metformin
Intervention descriptions: intervention 1: Omarigliptin 25 mg capsule administered orally once a week intervention 2: Matching placebo to omarigliptin capsule administered orally once a week intervention 3: 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. intervention 4: Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose \>=1500 mg

Protocol document: