Last updated on May 2019

Effect of Efpeglenatide on Cardiovascular Outcomes

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:

  • Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) > 7%.
  • Age 18 years or older with established cardiovascular disease or age 50 years (male), 55 years (female) or older with eGFR 25 and <60 mL/min and at least one cardiovascular risk factor.
  • Female patients must agree to follow contraceptive guidance.
  • Signed written informed consent.

Exclusion criteria:

  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting.
  • History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to screening.
  • Personal or family history of medullary thyroid cancer (MTC).
  • Hypertension (with a systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg).
  • Hospitalization for hypertensive emergency within 3 months prior to randomization.
  • Planned coronary procedure or surgery after randomization.
  • No documented ophthalmologic exam with fundoscopy within 6 months prior to randomization.
  • Retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study.
  • Treated with any glucagon-like peptide-1 (GLP-1) receptor agonist product alone (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening.
  • Use of any DPP4 inhibitor within 3 months prior to screening.
  • Antihyperglycemic treatment has not been stable within 3 months prior to screening.

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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