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

Conditions

• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Efpeglenatide — DRUG
  Pharmaceutical form: solution for injection; Route of administration: SC
• Dulaglutide — 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.

Study Details

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.

Key Dates

Start date

Sep 26, 2018

Status verified

Oct 2021

Primary completion

Oct 13, 2020

Completion

Nov 17, 2020

Study Design

Enrollment

908 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Efpeglenatide 4 mg
  Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.
• Experimental: Efpeglenatide 6 mg
  Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.
• Active Comparator: Dulaglutide 1.5 mg
  Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.

Primary Outcome Measure

Change From Baseline to Week 56 in HbA1c [ Time Frame: Baseline to Week 56 ]

Locations (30)

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