DRUG
Efpeglenatide
Pharmaceutical form: solution for injection; Route of administration: SC
Status
Terminated
Phase
Phase 3
Enrollment
908
Locations
45
Results
Posted
Publications
0
Study 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.
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.
Interventions
DRUG
Pharmaceutical form: solution for injection; Route of administration: SC
DRUG
Pharmaceutical form: solution for injection; Route of administration: SC
DRUG
Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.
Timeline
First posted
Sep 26, 2018
Study start
Sep 26, 2018
Primary completion
Oct 13, 2020
Study completion
Nov 17, 2020
Results posted
Nov 1, 2021
Registry updated
Nov 1, 2021
Outcomes
Change From Baseline to Week 56 in HbA1c
Time frame · 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.
Change From Baseline to Week 56 in Body Weight
Time frame · 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 %
Time frame · 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)
Time frame · 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)
Time frame · 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
Time frame · 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.
Eligibility
Inclusion criteria: * Participant must be greater than or equal to (\>=) 18 years of age at the time of signing the informed consent. * Participants with T2DM. * Diabetes diagnosed at least 1 year before screening. * Participants on stable dose of at least 1500 milligram per day (mg/day) of metformin, or tolerated maximum dose, or as per country regulation if less, for at least 3 months prior to screening. * HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory at screening. Exclusion criteria: * Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery. * Clinically relevant history of gastrointestinal (GI) disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease requiring medical treatment within 6 months prior to screening or history of surgery affecting gastric emptying. * History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy had been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy. * Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes). * Body weight change of greater than or equal to (\>=) 5 kilogram within the last 3 months prior to screening. * Systolic blood pressure greater than (\>)180 millimeter of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg at randomization. * Severe renal disease as defined by estimated glomerular filtration rate (eGFR), by Modification of Diet in Renal Disease (MDRD)\] of less than (\<)30 mL/min/1.73 m\^2. * Laboratory findings at the screening visit: * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 \* upper limit of normal (ULN) or total bilirubin \>1.5 \* ULN (except in case of documented Gilbert's syndrome); * Amylase and/or lipase: \>3 \* ULN; * Calcitonin \>=5.9 picomoles per liter (pmol/L) (20 picograms per milliliter). * Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to screening, or planned during study period. * Pregnant (confirmed by serum pregnancy test at screening) or breast-feeding women. * Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control or who are unwilling to be tested for pregnancy during the study period and for at least 5 weeks after the last dose of study intervention. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study locations
Hungary · Poland · Ukraine · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Investigational Site Number 8400050
Waterbury, Connecticut, United States
Investigational Site Number 8400055
Orlando, Florida, United States
Investigational Site Number 8400041
Pembroke Pines, Florida, United States
Investigational Site Number 8400025
Lawrenceville, Georgia, United States
Investigational Site Number 8400060
Meridian, Idaho, United States
Investigational Site Number 8400059
Skokie, Illinois, United States
Investigational Site Number 8400044
Lexington, Kentucky, United States
Investigational Site Number 8400061
Boston, Massachusetts, United States
Investigational Site Number 8400001
Bridgeton, New Jersey, United States
Investigational Site Number 8400039
New Windsor, New York, United States
Investigational Site Number 8400028
Burlington, North Carolina, United States
Investigational Site Number 8400036
Morehead City, North Carolina, United States
Investigational Site Number 8400013
Maumee, Ohio, United States
Investigational Site Number 8400014
Goose Creek, South Carolina, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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