Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03684642
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.
Secondary Objectives:
* To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on glycemic control.
* To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on body weight.
* To evaluate the safety of once weekly injection of efpeglenatide and once weekly injection of dulaglutide.
- Detailed Description
Study duration per participant was approximately 65 weeks including an up to 3-week Screening Period, a 56-week Treatment Period and a 6-week safety Follow-up Period.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 908
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Efpeglenatide 6 mg Efpeglenatide Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration. Efpeglenatide 4 mg Efpeglenatide Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration. Efpeglenatide 4 mg Background therapy Metformin Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration. Efpeglenatide 6 mg Background therapy Metformin Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration. Dulaglutide 1.5 mg Dulaglutide Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration. Dulaglutide 1.5 mg Background therapy Metformin Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 56 in HbA1c Baseline to Week 56 Adjusted Least square (LS) means and Standard errors (SE) were obtained from analysis of covariance (ANCOVA) model to account for missing data. Missing values were imputed by baseline observation carried forward (BOCF)-like multiple imputation method.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 56 in Body Weight Baseline to Week 56 Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.
Number of Participants With HbA1c < 7.0 % Week 56 Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders.
Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG) Baseline to Week 56 Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia) Baseline up to Week 56 Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<54 milligrams per deciliter (mg/dL) (\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year Baseline up to Week 56 Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<54 mg/dL (\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Trial Locations
- Locations (45)
Investigational Site Number 8400038
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 8400035
🇺🇸Chandler, Arizona, United States
Investigational Site Number 8400005
🇺🇸Glendale, Arizona, United States
Investigational Site Number 8400054
🇺🇸Peoria, Arizona, United States
Investigational Site Number 8400057
🇺🇸Huntington Park, California, United States
Investigational Site Number 8400009
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400007
🇺🇸San Diego, California, United States
Investigational Site Number 8400045
🇺🇸Spring Valley, California, United States
Investigational Site Number 8400040
🇺🇸Tustin, California, United States
Investigational Site Number 8400026
🇺🇸Van Nuys, California, United States
Scroll for more (35 remaining)Investigational Site Number 8400038🇺🇸Birmingham, Alabama, United States