At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Sitagliptin phosphate, Comparator: Placebo, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 380 participants.
Detailed 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.
Study Details
Timeline
Interventions
Sitagliptin, 100 mg tablet once daily, orally for 24 weeks
Placebo, to match sitagliptin tablet, once daily, orally for 24 weeks
Acarbose 50 mg or 100 mg tablet, 3 times daily, orally (continuing on the stable dose established prior to screening) for 24 weeks
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.