A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)

PHASE3CompletedINTERVENTIONAL
Enrollment

492

Participants

Timeline

Start Date

January 15, 2008

Primary Completion Date

January 8, 2010

Study Completion Date

January 16, 2010

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Comparator: sitagliptin phosphate (sitagliptin)

sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period

DRUG

sitagliptin phosphate (+) metformin hydrochloride

sitagliptin/metformin HCl (Sita/Met) 50/500 mg b.i.d. orally and then 50/1000 mg b.i.d. orally for a 28-wk treatment period

DRUG

Comparator: pioglitazone

pioglitazone 15 mg tablet q.d. orally for 6 weeks, followed by 30 mg q.d orally for 6 weeks, followed by 45 mg q.d. orally, up to 40 weeks.

DRUG

Matching placebo to pioglitazone

"matching placebo to pioglitazone tablet q.d. orally, for a 40-wk treatment period.~Participants were administered matching placebo the 15 mg pioglitazone q.d. orally for 6 weeks, followed by matching placebo to 30 mg pioglitazone q.d orally for 6 weeks, followed by matching placebo to 45 mg pioglitazone q.d. orally, up to 40 weeks."

DRUG

Matching placebo to sitagliptin

matching placebo to sitagliptin q.d., orally for a 12-wk treatment period.

DRUG

Matching Placebo to Sita/Met FDC

matching placebo to Sita/Met FDC - 50/500 mg b.i.d. for 4 weeks and then 50/1000 mg b.i.d. orally for a 28-wk treatment period (Week 12 to Week 40).

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00541450 - A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED) | Biotech Hunter | Biotech Hunter