Last updated on August 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: NIDDM
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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