A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)

PHASE3CompletedINTERVENTIONAL
Enrollment

329

Participants

Timeline

Start Date

December 5, 2012

Primary Completion Date

June 19, 2015

Study Completion Date

June 19, 2015

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Omarigliptin

Omarigliptin 25 mg capsule administered orally once a week.

DRUG

Placebo to Omarigliptin

Placebo to omarigliptin capsule administered orally once a week

DRUG

Metformin

If necessary, participants may have glycemic rescue therapy initiated with open-label metformin during Phase A of the study. Participants in the placebo treatment group who were not rescued with open-label metformin during Phase A will receive blinded metformin (starting at 500 mg orally twice daily with up-titration to 1000 mg orally twice daily) in Phase B. Participants in the omarigliptin treatment group who were rescued with open-label metformin in Phase A will continue open-label metformin during Phase B of the study.

DRUG

Placebo to metformin

During Phase B of the study, participants in the omarigliptin treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study).

DRUG

Glimepiride

If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic rescue therapy

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01717313 - A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011) | Biotech Hunter | Biotech Hunter