Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 751
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 with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study 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 will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks. arm 2: Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.

Interventions: intervention 1: Omarigliptin intervention 2: Placebo to Omarigliptin intervention 3: Glimepiride intervention 4: Glimepiride Placebo intervention 5: Metformin intervention 6: Insulin Glargine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia. intervention 4: None intervention 5: Participants will continue on their stable dose (\>=1500 mg/day) of open-label metformin throughout the trial. intervention 6: Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.

Protocol document: