A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk

sanofi-aventis recherche & développement0 个研究点目标入组 4,076 人开始时间: 2018年3月21日最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•-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

•-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.

发起方