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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
908
Pharmaceutical form: solution for injection; Route of administration: SC
Pharmaceutical form: solution for injection; Route of administration: SC
Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.
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
Change From Baseline to Week 56 in HbA1c
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.
Time frame: Baseline to Week 56
Change From Baseline to Week 56 in Body Weight
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.
Time frame: Baseline to Week 56
Number of Participants With HbA1c < 7.0 %
Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders.
Time frame: Week 56
Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)
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.
Time frame: Baseline to Week 56
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)
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.
Time frame: Baseline up to Week 56
Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year
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.
Time frame: Baseline up to Week 56
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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
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