drugset / Trial / NCT03684642

Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

NCT03684642

Phase 3 Terminated 908 enrolled Sanofi Hanmi Pharmaceutical Company Limited · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: To demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Secondary Objectives: * To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on glycemic control. * To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on body weight. * To evaluate the safety of once weekly injection of efpeglenatide and once weekly injection of dulaglutide.

Timeline

Start
2018-09-26
Primary completion
2020-10-13
Completion
2020-11-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dulaglutide Peptide 1.5 mg Subcutaneous
Subject Efpeglenatide Peptide 4 mg Subcutaneous
Subject Efpeglenatide Peptide 6 mg Subcutaneous
Background Metformin Small molecule Oral