Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Hypoglycemic Agents Pharmacologic Actions Therapeutic Uses
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 203
Healthy volunteers: no

Brief summary:
This study will examine the safety and efficacy of once-weekly omarigliptin in participants 18 to \<45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The study hypothesis is that treatment with omarigliptin compared with placebo provides greater reduction in hemoglobin A1c (A1C) in participants after 24 weeks.

Detailed description:

Arms:
arm 1: Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited. arm 2: Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.

Interventions: intervention 1: Omarigliptin intervention 2: Placebo to omarigliptin intervention 3: Metformin
Intervention descriptions: intervention 1: Omarigliptin 25 mg capsule administered orally once weekly intervention 2: Matching placebo to omarigliptin 25 mg capsule administered orally once weekly intervention 3: Open-label metformin (dosed daily according to the country-specific product label) was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.

Protocol document: