A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024)

PHASE3CompletedINTERVENTIONAL
Enrollment

402

Participants

Timeline

Start Date

January 11, 2013

Primary Completion Date

March 16, 2016

Study Completion Date

March 16, 2016

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Omarigliptin

Omarigliptin 25 mg capsule administered orally once weekly (preferably on the same day of each week)

DRUG

Matching placebo to omarigliptin

Matching placebo to omarigliptin capsule administered orally once weekly (preferably on the same day of each week)

DRUG

Glimepiride

Glimepiride 1 or 2 mg tablet/capsule administered orally once daily and up-titrated to a maximum dose of 6 mg daily. Participants rescued with open-label glimepiride during Phase A will not receive glimepiride or matching placebo to glimepiride during Phase B.

DRUG

Matching placebo to glimepiride

Matching placebo to glimepiride tablet/capsule administered orally once daily and up-titrated to a mock maximum dose of 6 mg daily. Participants rescued with open-label glimepiride during Phase A will not receive glimepiride or matching placebo to glimepiride during Phase B.

DRUG

Insulin glargine

During Phase B of the study, participants who received a maximum up-titration of open-label glimepiride or blinded glimepiride/matching placebo to glimepiride, may be rescued with open-label insulin glargine.

DRUG

Metformin

Participants continue stable pre-study dose of metformin tablet(s) administered orally (\>= 1500 mg daily) throughout the study.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01755156 - A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024) | Biotech Hunter | Biotech Hunter