Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 406
Not provided
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
Related Research Topics
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Trial Locations
- Locations (54)
Investigational Site Number 8400004
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 8400005
🇺🇸Glendale, Arizona, United States
Investigational Site Number 8400003
🇺🇸Canoga Park, California, United States
Investigational Site Number 8400007
🇺🇸Chula Vista, California, United States
Investigational Site Number 8400011
🇺🇸La Mesa, California, United States
Investigational Site Number 8400009
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400029
🇺🇸Pomona, California, United States
Investigational Site Number 8400024
🇺🇸Tarzana, California, United States
Investigational Site Number 8400026
🇺🇸Van Nuys, California, United States
Investigational Site Number 8400010
🇺🇸DeLand, Florida, United States
Scroll for more (44 remaining)Investigational Site Number 8400004🇺🇸Birmingham, Alabama, United States