A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

PHASE3CompletedINTERVENTIONAL
Enrollment

751

Participants

Timeline

Start Date

September 10, 2012

Primary Completion Date

January 26, 2015

Study Completion Date

January 26, 2015

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Omarigliptin

DRUG

Placebo to Omarigliptin

DRUG

Glimepiride

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.

DRUG

Glimepiride Placebo

DRUG

Metformin

Participants will continue on their stable dose (\>=1500 mg/day) of open-label metformin throughout the trial.

DRUG

Insulin Glargine

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.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01682759 - A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016) | Biotech Hunter | Biotech Hunter