Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone or in combination with sulfonylurea (SU). 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.
Study duration per participant was approximately 39 weeks including an up to 3-week Screening Period, a 30-week Treatment Period, and a 6-week safety Follow-up Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
312
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling.
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 8400042
Mesa, Arizona, United States
Investigational Site Number 8400051
Phoenix, Arizona, United States
Change From Baseline to Week 30 in HbA1c
This analysis included all Week 30 assessment values available.
Time frame: Baseline to Week 30
Number of Participants With HbA1c <7.0%
Participants who had no available assessment for HbA1c \<7% at Week 30 were considered as non-responders.
Time frame: Week 30
Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)
This analysis included all Week 30 assessment values available.
Time frame: Baseline to Week 30
Change From Baseline to Week 30 in Body Weight
This analysis included all Week 30 assessment values available.
Time frame: Baseline to Week 30
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 30
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 30
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Investigational Site Number 8400056
Tucson, Arizona, United States
Investigational Site Number 8400057
Huntington Park, California, United States
Investigational Site Number 8400009
Los Angeles, California, United States
Investigational Site Number 8400045
Spring Valley, California, United States
Investigational Site Number 8400040
Tustin, California, United States
...and 38 more locations