Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)

PHASE3CompletedINTERVENTIONAL
Enrollment

273

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

March 31, 2007

Study Completion Date

March 31, 2007

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Sitagliptin

Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.

DRUG

Comparator: Rosiglitazone

Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.

DRUG

Comparator: Placebo

placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.

DRUG

Comparator: Metformin

Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of \>= 1500 mg.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00541775 - Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801) | Biotech Hunter | Biotech Hunter