A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)

PHASE2CompletedINTERVENTIONAL
Enrollment

555

Participants

Timeline

Start Date

August 19, 2003

Primary Completion Date

July 21, 2004

Study Completion Date

May 14, 2006

Conditions
Type II Diabetes Mellitus
Interventions
DRUG

Sitagliptin

DRUG

Placebo to sitagliptin

DRUG

Metformin

DRUG

Rescue

Patients whose FPG \>240 mg/dL from Week 16 or HbA1C \>8.5% from Week 25 up to (not including) Week 52 could receive rescue antihyperglycemic therapy with pioglitazone, and remain in the extension study (Extension 1). Participants were eligible for rescue with pioglitazone 30 mg (or rosiglitazone in countries where pioglitazone was not licensed) if they met the following criteria: from Week 16 and during the second extension: FPG consistently \>240 mg/dL (repeated and confirmed within 3 to 7 days); from Week 52 up to (not including) Week 70: HbA1C \>8%; from Week 70 up to (not including) Visit 21/Week 106: HbA1C \>7.5% (Extension 2). Participants placed on rescue therapy with pioglitazone (rosiglitazone where pioglitazone is not available) in the first or second extensions were not eligible for enrollment in the third extension. Rescue therapy was not available in the third extension.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00481663 - A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014) | Biotech Hunter | Biotech Hunter