Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus T2DM
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 380
Healthy volunteers: no

Brief summary:
This study will evaluate whether the addition of sitagliptin reduces hemoglobin A1C (A1C) more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg once daily (q.d.) reduces A1C more than the addition of placebo in participants with T2DM with inadequate glycemic control on acarbose monotherapy.

Detailed description:
The study includes an 8-week antihyperglycemic agent (AHA) wash-off period\* (which includes a 2-week single-blind placebo run-in period) followed by a 24-week double-blind treatment period. All participants will receive open-label acarbose at a minimum dose of 50 mg three times daily (t.i.d.) during the run-in and treatment periods.

\*: Wash-off only applicable to patients who were on acarbose and another AHA.

Arms:
arm 1: Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\]) arm 2: Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)

Interventions: intervention 1: Sitagliptin phosphate intervention 2: Comparator: Placebo intervention 3: Acarbose intervention 4: Glimepiride
Intervention descriptions: intervention 1: Sitagliptin, 100 mg tablet once daily, orally for 24 weeks intervention 2: Placebo, to match sitagliptin tablet, once daily, orally for 24 weeks intervention 3: Acarbose 50 mg or 100 mg tablet, 3 times daily, orally (continuing on the stable dose established prior to screening) for 24 weeks intervention 4: Participants not meeting specific glycemic goals during the study will use glimepiride as rescue therapy. For countries where glimepiride is not available, participants will receive a sulfonylurea marketed in that country as rescue therapy.

Protocol document: