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Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

NCT03353350

CompletedPhase 3

Sponsor: Hanmi Pharmaceutical Company Limited

Conditions: Type 2 Diabetes Mellitus

Interventions: efpeglenatide (SAR439977), placebo

Countries: United States, Germany, Poland, Ukraine, United Kingdom

Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise. 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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

* Participants must be at least 18 years of age at the time of signing the informed consent.
* Participants with T2DM, and treated with diet and exercise.
* Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.

Exclusion criteria:

* 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 within 6 months prior to Screening or history of surgery affecting gastric emptying.
* History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy has been performed) and pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, and pancreatectomy.
* Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes).
* Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.
* Body weight change of ≥5 kg within the last 3 months prior to Screening.
* Systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg at Randomization.
* End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by Modification of Diet in Renal Disease \[MDRD\]) of \<15 mL/min/1.73 m2.
* Laboratory findings at the Screening Visit:
* Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) \>3 times the upper limit of the normal (ULN ) or total bilirubin \>1.5 times the ULN (except in case of documented Gilbert's syndrome).
* Amylase and/or lipase: \>3 times the ULN laboratory range.
* Calcitonin ≥5.9 pmol/L (20 pg/mL).
* Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period.
* History of drug or alcohol abuse within 6 months prior to the time of Screening.
* Pregnant (demonstrated 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 during the study period and for at least 5 weeks after the last dose of study intervention.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (54)

Birmingham, Alabama, United States
Glendale, Arizona, United States
Canoga Park, California, United States
Chula Vista, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Pomona, California, United States
Tarzana, California, United States
Van Nuys, California, United States
DeLand, Florida, United States
Hialeah, Florida, United States
West Palm Beach, Florida, United States
Lawrenceville, Georgia, United States
Chicago, Illinois, United States
Kansas City, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Bridgeton, New Jersey, United States
Burlington, North Carolina, United States
Wilmington, North Carolina, United States
Maumee, Ohio, United States
Hatboro, Pennsylvania, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
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