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

NCT03684642 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 908

Last updated 2021-11-01

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2020-10-13
Completion
2020-11-17
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03684642 on ClinicalTrials.gov