A Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab Versus Usual Care in Patients with Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk with Non-HDL-C Not Adequately Controlled with Maximally Tolerated Statin Therapy - ODYSSEY DM - DYSLIPIDEMIA

Sanofi-Aventis Groupe0 个研究点目标入组 413 人开始时间: 2016年2月2日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•-Patients with type 2 diabetes and mixed dyslipidemia whose non-high-density lipoprotein cholesterol (non-HDL-C) is not adequately controlled with a stable, maximum dose/regimen of statin that is tolerated by the patient.
•-18 years of age or more.
•-Documented history of atherosclerotic cardiovascular disease (ASCVD) or at least one additional cardiovascular risk factor.
•-Non-HDL-C of 100 mg/dL or greater.
•-Triglycerides greater than or equal to 150 mg/dL and less than 500 mg/dL.
•-Stable anti-hyperglycemic agents for at least 3 months.
•-No change in weight of more than 5 kg within the prior 3 months.
•-On stable dose of medications that are known to influence weight and/or lipids within the last 3 months.
•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 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 170

•-Use of any lipid modifying therapies other than statins within the last 4 weeks (eg, ezetimibe, fenofibrate, nicotinic acid, omega-3 fatty acids, etc.) or use of over the counter products/nutraceuticals known to impact lipids (eg, red yeast rice) within the last 4 weeks.
•-Currently drinking more than 2 standard alcoholic drinks per day.
•-Body Mass Index (BMI) >45 kg/m² or currently enrolled in a weight loss program and still in active phase of weight loss.
•-Glycosylated hemoglobin (HbA1c) 9% or greater.

发起方