Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

PHASE3CompletedINTERVENTIONAL
Enrollment

741

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

July 31, 2005

Study Completion Date

February 28, 2007

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Sitagliptin (MK0431)

Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.

DRUG

Sitagliptin

Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.

DRUG

Placebo

Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.

DRUG

Placebo

Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.

DRUG

Metformin - Rescue

Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00087516 - Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021) | Biotech Hunter | Biotech Hunter