Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 427
Healthy volunteers: no

Brief summary:
This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.

Detailed description:

Arms:
arm 1: Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg arm 2: Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone

Interventions: intervention 1: Sitagliptin phosphate intervention 2: Comparator: placebo to pioglitazone intervention 3: Comparator: placebo to Sitagliptin intervention 4: Comparator: pioglitazone intervention 5: Glimepiride or gliclazide intervention 6: Metformin intervention 7: Pioglitazone rescue therapy
Intervention descriptions: intervention 1: Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks intervention 2: Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks intervention 3: Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks intervention 4: Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks intervention 5: Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide intervention 6: Phase A (Weeks 0-24): stable dose, as prescribed

by investigator, of metformin; Phase B (Weeks 24-

54): stable dose, as prescribed by investigator, of

metformin intervention 7: Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.

Protocol document: