Effect of Efpeglenatide on Cardiovascular Outcomes

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 21.1Level: 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-IT
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-25
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5000

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.
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) 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified