Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 498
Healthy volunteers: no

Brief summary:
A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.

Detailed description:

Arms:
arm 1: Sitagliptin 100 mg once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during run-in period. arm 2: Matching placebo once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Interventions: intervention 1: Sitagliptin intervention 2: Placebo intervention 3: Gliclazide intervention 4: Glimepiride intervention 5: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg oral tablet once daily for 24 weeks intervention 2: Matching placebo to sitagliptin oral tablet once daily for 24 weeks intervention 3: Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study. intervention 4: Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study. intervention 5: Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.

Protocol document: