drugset / Trial / NCT01177384

Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)

NCT01177384

Phase 3 Completed 380 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2011-01-25
Primary completion
2013-03-25
Completion
2013-03-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Sitagliptin Small molecule 100 mg Oral
Background Acarbose Unknown 50 mg Oral
Background Acarbose Unknown 100 mg Oral
Background Glimepiride Small molecule