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

NCT03684642 · Terminated

Last updated 2026-05-28

This clinical trial compared the effects of efpeglenatide and dulaglutide on blood sugar control in adults with type 2 diabetes who were not well-managed with metformin alone.

Status Terminated Stopped early and will not restart.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 908 people

Who can join Ages 18+ · all sexes

Timeline Started 2018-09 · est. completion 2020-11

Where 45 sites · Hungary, Poland, Ukraine, United States

What this study is testing ClinicalTrials.gov NCT03684642 ↗

Description as written by the study sponsor.

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.

Treatments tested

Efpeglenatide also known as SAR439977 Drug

Pharmaceutical form: solution for injection; Route of administration: SC
Dulaglutide also known as Trulicity™ Drug

Pharmaceutical form: solution for injection; Route of administration: SC
Background therapy Metformin Drug

Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.

Main thing measured	Change From Baseline to Week 56 in HbA1c
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	dulaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03684642 ↗