DRUG
Efpeglenatide SAR439977
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Status
Terminated
Phase
Phase 3
Enrollment
370
Locations
47
Results
Posted
Publications
0
Study 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 type 2 diabetes mellitus (T2DM) inadequately controlled with basal insulin alone or in combination with oral antidiabetic drugs (OADs). 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 64 weeks including an up to 2-week Screening Period, a 30-week Core Treatment Period, a 26-week Safety Extension Period, and a 6-week safety Follow-up Period.
Interventions
DRUG
Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG
Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG
Lantus (Insulin Glargine), SC, once daily; OADs, administered as per investigator prescription and in accordance with local labeling.
Timeline
First posted
Oct 22, 2018
Study start
Nov 9, 2018
Primary completion
Nov 20, 2020
Study completion
Jan 4, 2021
Results posted
Dec 2, 2021
Registry updated
Dec 2, 2021
Outcomes
Change From Baseline to Week 30 in HbA1c
Time frame · Baseline to Week 30
Number of Participants With HbA1c <7.0% at Week 30
Time frame · Week 30
Participants who had no available assessment for HbA1c at Week 30 were considered as non-responders.
Change From Baseline to Week 56 in HbA1c
Time frame · Baseline to Week 56
This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.
Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)
Time frame · Baseline to Week 30
Change From Baseline to Week 30 and Week 56 in Body Weight
Time frame · Baseline to Week 30 and Week 56
This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and 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 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 basal insulin regimen alone or in combination with OADs for at least 6 months prior to screening. * HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory at screening. Exclusion criteria: * History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening. * 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 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. * History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has 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 predispose to MTC (e.g., multiple endocrine neoplasia syndromes). * Body weight change of \>=5 kilograms within the last 3 months prior to screening. * Systolic blood pressure greater than (\>)180 millimetres of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg at randomization. * End-stage renal disease as defined by estimated glomerular filtration rate (by Modification of Diet in Renal Disease) of less than 15 mL/min/1.73 m\^2. * Laboratory findings at the screening Visit: * Alanine aminotransferase or aspartate aminotransferase \>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 \[pg/mL\]). * 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 not willing to use highly effective method(s) of birth control or who were 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
China · South Korea · 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 8400057
Huntington Park, California, United States
Investigational Site Number 8400058
La Jolla, 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
Investigational Site Number 8400026
Van Nuys, California, 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 8400052
West Des Moines, Iowa, United States
Investigational Site Number 8400044
Lexington, Kentucky, United States
Investigational Site Number 8400001
Bridgeton, New Jersey, United States
Investigational Site Number 8400039
New Windsor, New York, United States
Investigational Site Number 8400036
Morehead City, North Carolina, United States
Investigational Site Number 8400013
Maumee, Ohio, United States
Investigational Site Number 8400030
Dallas, Texas, United States
Investigational Site Number 8400063
Dallas, Texas, United States
Investigational Site Number 8400043
San Antonio, Texas, United States
Investigational Site Number 8400037
Layton, Utah, United States
Investigational Site Number 1560005
Baotou, China
Investigational Site Number 1560017
Beijing, China
Publications
No PMID-linked publications were present in this registry snapshot.
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