Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Acarbose Monotherapy
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.
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.
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