Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 292
Healthy volunteers: no

Brief summary:
This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®), MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior reduction in HbA1c (mean change from baseline) compared to glimepiride.

Detailed description:

Arms:
arm 1: Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks. arm 2: Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.

Interventions: intervention 1: Sitagliptin/Metformin FDC intervention 2: Comparator: Glimepiride intervention 3: Matching placebo to Sitagliptin/Metformin FDC intervention 4: Matching placebo to glimepiride
Intervention descriptions: intervention 1: Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks intervention 2: Glimepiride tablet orally up to 6 mg daily for 30 Weeks intervention 3: Matching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks intervention 4: Matching placebo to glimepiride tablet orally daily for 30 weeks

Protocol document: