NCT03684642

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

A 56-week, Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly Compared to Dulaglutide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 908 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study duration per participant was approximately 65 weeks including an up to 3-week Screening Period, a 56-week Treatment Period and a 6-week safety Follow-up Period.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Efpeglenatide	Pharmaceutical form: solution for injection; Route of administration: SC
DRUG	Dulaglutide	Pharmaceutical form: solution for injection; Route of administration: SC
DRUG	Background therapy Metformin	Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.

Timeline

• Start date: 2018-09-26
• Primary completion: 2020-10-13
• Completion: 2020-11-17
• First posted: 2018-09-26
• Last updated: 2021-11-01
• Results posted: 2021-11-01

Locations

45 sites across 4 countries: United States, Hungary, Poland, Ukraine

Regulatory

• FDA-regulated drug study