Last updated on September 2020

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)


Brief description of study

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 basal insulin alone or in combination with oral antidiabetic drugs (OADs).

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 Study Description

Study duration per participant is approximately 64 weeks including an up to 2-week Screening Period, a 30-week Core Treatment Period, a 26-week Safety Extension Period, and a 6-week safety Follow-up Period.

Clinical Study Identifier: NCT03713684

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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