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Efficacy and Safety of Efpegl...

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

Last Updated: 2022-01-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2020-09-07

Brief Summary

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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

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Detailed Description

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Study duration per participant is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Efpeglenatide 2mg

Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks

Group Type EXPERIMENTAL