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)

• Status: Terminated
• Trial end date: 2021-01-04

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 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.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Efpeglenatide; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Globin Zinc