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Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

NCT03353350 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2022-01-18

Study results available
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Summary

Primary Objective:

To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise.

Secondary Objectives:

* To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on glycemic control
* To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on body weight
* To evaluate the safety of once-weekly injection of efpeglenatide

Conditions

Interventions

DRUG

efpeglenatide (SAR439977)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-05
Primary Completion
2020-01-29
Completion
2020-09-07
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Poland
  • Ukraine
  • United Kingdom

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 NCT03353350 on ClinicalTrials.gov