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

• Status: Completed
• Trial end date: 2020-09-07
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited; Sanofi
• Collaborator: Sanofi
• Treatments: Efpeglenatide

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.