Effect of Efpeglenatide on Cardiovascular Outcomes in High Cardiovascular Risk Type 2 Diabetes Patients

Phase 1

Conditions: Type 2 diabetes mellitus
MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2017-002954-35-NO

Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 4076

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.
-Male and female patients must agree to follow contraceptive guidance.
-Signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

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.
-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 screening
-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 products (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) within 3 months prior to screening.
-Use of any DPP4 inhibitor within 12 weeks prior to screening
-Antihyperglycemic treatment has not been stable within 12 weeks prior to screening.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main 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 Objective: -To demonstrate that efpeglenatide doses 1 and 2 is superior to placebo in T2DM patients with high CV risk on the following parameters:<br> -3-point MACE<br> -Expanded CV outcome.<br> -Composite outcome of new or worsening nephropathy.<br>-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.;Primary end point(s): Time to first Major Adverse Cardiovascular Event (MACE): Time to the first occurrence of any of the following clinical events: cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke;Timepoint(s) of evaluation of this end point: Baseline to approximately 36 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Time to first expanded cardiovascular outcome event: Time to the first occurrence of any of the following clinical events, positively adjudicated by the clinical endpoint committee (CEC): cardiovascular death, non-fatal MI, non-fatal stroke, coronary revascularization, hospitalization for unstable angina.<br>2) Time to first composite renal event: Time to the first occurrence of any of the following clinical events: new onset or progression to macro albuminuria (>300 mg/g) accompanied by a UACR value increase of =30% from baseline, sustained =40% decrease in eGFR from baseline (for =30 days), chronic dialysis (for =90 days), renal transplant, sustained eGFR <15 mL/min/1.73 m2 (for =30 days).<br>3) Adverse Events (AEs): Number of patients with AEs;Timepoint(s) of evaluation of this end point: 1) to 3) Baseline to approximately 36 months

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