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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: efpeglenatide (SAR439977); Drug: placebo

• Registration Number: NCT03353350
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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 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.

Study Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-27
• Study Start: 2017-12-05
• Primary Completion: 2020-01-29
• Study Completion: 2020-09-07
• Disposition First Submitted: 2021-01-26
• Results First Submitted: 2021-09-29
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-11
• Disposition First Submitted QC: 2022-01-11
• Last Update Submitted: 2022-01-11
• Results First Posted: 2022-01-18
• Disposition First Posted: 2022-01-18
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Efpeglenatide 2mg	efpeglenatide (SAR439977)	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks
Efpeglenatide 4 mg	efpeglenatide (SAR439977)	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
Efpeglenatide 6 mg	efpeglenatide (SAR439977)	Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
Placebo	placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks

Primary Outcome Measures

Name	Time	Method
Change in Glycated Hemoglobin (HbA1c) (%)	Baseline to Week 30	Change from Baseline to Week 30 in HbA1c

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c (%)	Baseline to Week 56	Change from Baseline to Week 56 in HbA1c
HbA1c <7%	Week 30	Number of participants with HbA1c \<7.0% at Week 30
Change in Body Weight at Week 30	Baseline to Week 30	Change from Baseline to Week 30 in body weight
Change in Body Weight at Week 56	Baseline to Week 56	Change from Baseline to Week 56 in body weight
Hypoglycemic Participants	Baseline to Week 56	Number of participants with at least 1 hypoglycemic event during treatment period
Hypoglycemic Events	Baseline to Week 56	Number of hypoglycemic events
Change in Fasting Plasma Glucose (FPG)	Baseline to Week 30	Change from Baseline to Week 30 in FPG
Treatment Emergent Adverse Events (TEAEs)	Baseline to Week 56	Number of participants with TEAEs

Trial Locations

Locations (54)

Investigational Site Number 6160001; 🇵🇱 Wroclaw, Poland

Investigational Site Number 8400004; 🇺🇸 Birmingham, Alabama, United States

Investigational Site Number 8400021; 🇺🇸 Las Vegas, Nevada, United States

Investigational Site Number 8400062; 🇺🇸 Las Vegas, Nevada, United States

Investigational Site Number 8400013; 🇺🇸 Maumee, Ohio, United States

Investigational Site Number 8400005; 🇺🇸 Glendale, Arizona, United States

Investigational Site Number 8400003; 🇺🇸 Canoga Park, California, United States

Investigational Site Number 8400029; 🇺🇸 Pomona, California, United States

Investigational Site Number 8400010; 🇺🇸 DeLand, Florida, United States

Investigational Site Number 8400011; 🇺🇸 La Mesa, California, United States

Investigational Site Number 8400025; 🇺🇸 Lawrenceville, Georgia, United States

Investigational Site Number 8400032; 🇺🇸 West Palm Beach, Florida, United States

Investigational Site Number 8400033; 🇺🇸 Kansas City, Missouri, United States

Investigational Site Number 8400006; 🇺🇸 Hialeah, Florida, United States

Investigational Site Number 8400015; 🇺🇸 Houston, Texas, United States

Investigational Site Number 8400027; 🇺🇸 San Antonio, Texas, United States

Investigational Site Number 2760005; 🇩🇪 Berlin, Germany

Investigational Site Number 8400002; 🇺🇸 Holladay, Utah, United States

Investigational Site Number 2760003; 🇩🇪 Frankfurt Am Main, Germany

Investigational Site Number 8040001; 🇺🇦 Kyiv, Ukraine

Investigational Site Number 6160007; 🇵🇱 Katowice, Poland

Investigational Site Number 6160004; 🇵🇱 Gdynia, Poland

Investigational Site Number 6160003; 🇵🇱 Warszawa, Poland

Investigational Site Number 6160006; 🇵🇱 Poznan, Poland

Investigational Site Number 8040003; 🇺🇦 Kyiv, Ukraine

Investigational Site Number 8040002; 🇺🇦 Kyiv, Ukraine

Investigational Site Number 8260005; 🇬🇧 Birmingham, United Kingdom

Investigational Site Number 8260004; 🇬🇧 Cardiff, United Kingdom

Investigational Site Number 8040004; 🇺🇦 Vinnitsa, Ukraine

Investigational Site Number 8260007; 🇬🇧 Chorley, United Kingdom

Investigational Site Number 8260006; 🇬🇧 Manchester, United Kingdom

Investigational Site Number 8260002; 🇬🇧 Reading, United Kingdom

Investigational Site Number 8400009; 🇺🇸 Los Angeles, California, United States

Investigational Site Number 8400007; 🇺🇸 Chula Vista, California, United States

Investigational Site Number 8400026; 🇺🇸 Van Nuys, California, United States

Investigational Site Number 8400024; 🇺🇸 Tarzana, California, United States

Investigational Site Number 8400034; 🇺🇸 Chicago, Illinois, United States

Investigational Site Number 8400018; 🇺🇸 Lincoln, Nebraska, United States

Investigational Site Number 8400028; 🇺🇸 Burlington, North Carolina, United States

Investigational Site Number 8400001; 🇺🇸 Bridgeton, New Jersey, United States

Investigational Site Number 8400031; 🇺🇸 Wilmington, North Carolina, United States

Investigational Site Number 8400017; 🇺🇸 Carrollton, Texas, United States

Investigational Site Number 8400008; 🇺🇸 Hatboro, Pennsylvania, United States

Investigational Site Number 8400030; 🇺🇸 Dallas, Texas, United States

Investigational Site Number 8400020; 🇺🇸 San Antonio, Texas, United States

Investigational Site Number 8400016; 🇺🇸 San Antonio, Texas, United States

Investigational Site Number 8400023; 🇺🇸 Schertz, Texas, United States

Investigational Site Number 6160005; 🇵🇱 Gdansk, Poland

Investigational Site Number 2760001; 🇩🇪 Leipzig, Germany

Investigational Site Number 6160002; 🇵🇱 Krakow, Poland

Investigational Site Number 8260008; 🇬🇧 Glasgow, United Kingdom

Investigational Site Number 8260001; 🇬🇧 Hexham, United Kingdom

Investigational Site Number 8260003; 🇬🇧 Liverpool, United Kingdom

Investigational Site Number 8400019; 🇺🇸 Plano, Texas, United States