drugset / Trial / NCT01296412

Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

NCT01296412

Phase 3 Completed 653 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based treatment.

Timeline

Start
2011-03-11
Primary completion
2012-02-29
Completion
2012-02-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Glimepiride Small molecule 1 mg Oral
Comparator Liraglutide Peptide 1.2 mg Subcutaneous
Comparator Liraglutide Peptide 1.8 mg Subcutaneous
Subject Sitagliptin Small molecule 100 mg Oral
Background Metformin Small molecule 1500 mg Oral