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Clinical trial

Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin (AMPLITUDE-D)

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Last updated:26th Sep 2018
Identifier: NCT03684642

Brief Summary:
Primary Objective:
To demonstrate the noninferiority 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

Detailed Description:
Study duration per participant is approximately 65 weeks including an up to 3-week Screening Period, a 56-week Treatment Period and a 6-week safety Follow-up Period.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: The study is open-label for the tested versus comparator drug and double blind for the doses.
Primary Purpose: Treatment
Official Title: A 56-week, Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly Compared to Dulaglutide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Actual Study Start Date: September 26, 2018
Estimated Primary Completion Date: December 2020
Estimated Study Completion Date: December 2020

Arms:
- Experimental:
Efpeglenatide middle dose
- Experimental: Efpeglenatide high dose
- Active Comparator: Dulaglutide

Category Value
Date last updated at source 2019-06-25
Study type(s) Interventional
Expected enrolment 900
Study start date 2018-09-26
Estimated primary completion date 2020-12-01

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