drugset / Trial / NCT01462266

Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260)

NCT01462266

Phase 3 Completed 660 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or in combination with metformin. The primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of insulin relative to placebo.

Timeline

Start
2012-01-13
Primary completion
2013-06-06
Completion
2013-06-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Sitagliptin Small molecule 100 mg
Background Metformin Small molecule 1500 mg Oral
Background insulin glargine Protein / enzyme biologic