Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03713684

Run by

Sanofi

People needed

370

Starts

2018-11-09

Expected to finish

2021-01-04

Last updated by the study team

2021-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Investigational Site Number 1560006 — Changsha, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.