Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 642
Healthy volunteers: no

Brief summary:
This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.

Detailed description:

Arms:
arm 1: Participants receive omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy. arm 2: Participants receive sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy.

Interventions: intervention 1: Omarigliptin intervention 2: Sitagliptin intervention 3: Placebo to omarigliptin intervention 4: Placebo to Sitagliptin intervention 5: Open-label Metformin intervention 6: Open-label Glimepiride
Intervention descriptions: intervention 1: Omarigliptin (MK-3102) 25 mg oral capsule once a week for 24 weeks intervention 2: Sitagliptin 100 mg oral tablet once a day for 24 weeks intervention 3: Placebo to omarigliptin 25 mg oral capsule once a week for 24 weeks intervention 4: Placebo to sitagliptin 100 mg oral tablet once a day for 24 weeks intervention 5: Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day intervention 6: Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy

Protocol document: