Purpose

Primary Objective: -To demonstrate that, efpeglenatide doses 1 and 2 is noninferior to placebo on 3-point major adverse cardiac event (MACE) in Type 2 diabetes mellitus (T2DM) patients at high cardiovascular (CV) risk. Secondary Objectives: - To demonstrate that efpeglenatide doses 1 and 2 is superior to placebo in T2DM patients with high CV risk on the following parameters: - 3-point MACE. - Expanded CV outcome. - Composite outcome of new or worsening nephropathy. - To assess the safety and tolerability of efpeglenatide doses 1 and 2, both added to standard of care in T2DM patients at high CV risk.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Efpeglenatide Dose 1
Efpeglenatide dose 1 once weekly
  • Drug: Efpeglenatide (SAR439977)
    Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental
Efpeglenatide Dose 2
Efpeglenatide dose 2 once weekly
  • Drug: Efpeglenatide (SAR439977)
    Pharmaceutical form: solution for injection Route of administration: subcutaneous
Placebo Comparator
Placebo
Placebo once weekly
  • Drug: Placebo
    Pharmaceutical form: solution for injection Route of administration: subcutaneous

More Details

Status
Active, not recruiting
Sponsor
Sanofi

Study Contact

Detailed Description

The estimated study duration per participant is up to approximately 36 months.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.