NCT03353350

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

A 56-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 Diet and Exercise

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise. 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 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	efpeglenatide (SAR439977)	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	placebo	Pharmaceutical form: solution for injection Route of administration: subcutaneous

Timeline

• Start date: 2017-12-05
• Primary completion: 2020-01-29
• Completion: 2020-09-07
• First posted: 2017-11-27
• Last updated: 2022-01-18
• Results posted: 2022-01-18

Locations

54 sites across 5 countries: United States, Germany, Poland, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study