Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 65
Healthy volunteers: no

Brief summary:
This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis is that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.

Detailed description:

Arms:
arm 1: Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks. arm 2: Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.

Interventions: intervention 1: Omarigliptin intervention 2: Glimepiride intervention 3: Omarigliptin Placebo intervention 4: Glimepiride Placebo
Intervention descriptions: intervention 1: Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly intervention 2: Glimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal intervention 3: Matching placebo to omarigliptin capsule administered orally once weekly intervention 4: Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal

Protocol document: