A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)

PHASE3CompletedINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

October 2, 2012

Primary Completion Date

January 19, 2016

Study Completion Date

January 19, 2016

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Omarigliptin

Participants with moderate renal insufficiency will receive one omarigliptin 25 mg capsule orally once a week; participants with severe renal insufficiency or end stage renal disease will receive one omarigliptin 12.5 mg capsule orally once a week

DRUG

Placebo to omarigliptin

Matching placebo to omarigliptin capsule administered orally once a week

DRUG

Glipizide

Phase A: Participants may receive open-label glipizide as rescue therapy up to Week 24 of the study. Phase B: Participants who received placebo to omarigliptin during Phase A and are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study Week 1 through Week 24) will receive glipizide capsule(s) 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).

DRUG

Placebo to glipizide

Matching placebo to glipizide daily

BIOLOGICAL

Insulin

Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01698775 - A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019) | Biotech Hunter | Biotech Hunter