Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea (AMPLITUDE-S)

Brief 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 type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone or in combination with sulfonylurea (SU).

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.

Detailed Description:
Study duration per participant is approximately 39 weeks including an up to 3-week Screening Period, a 30-week Treatment Period, and a 6-week safety Follow-up Period.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 30-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
Estimated Study Start Date: July 18, 2019
Estimated Primary Completion Date: February 2021
Estimated Study Completion Date: June 2021

Arms:
- Experimental: Efpeglenatide low dose
- Experimental: Efpeglenatide middle dose
- Experimental: Efpeglenatide high dose
- Placebo Comparator: Placebo