EUCTR2015-000799-92-DE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of Alirocumab in insulin treated patients with type 1 or type 2 diabetes and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. - ODYSSEY DM-Insulin
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with type 1 or type 2 diabetes treated with insulin whose LDL-C levels are not adequately controlled with maximally tolerated lipid-modifying therapy.
- •LDL-C of 70 mg/dL or greater.
- •18 years of age or more.
- •Glycosylated hemoglobin (HbA1c) less than 10%.
- •History of cardiovascular disease (including CHD and/or CHD risk equivalents) and/or at least one additional cardiovascular risk factor.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Not on a stable dose of statin or other lipid modifying therapy for at least 4 weeks prior to screening.
- •Triglycerides >400 mg/dL.
- •Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m^2 according to modification in diet of renal disease (MDRD) equation.
- •Currently receiving or plans to receive renal replacement therapy (for example, hemodialysis).
- •Change in weight of more than 5 kilograms within the prior 2 months.
- •Not on a stable dose/regimen of insulin or other antidiabetic drugs for the past 3 months or plans to intensify insulin regimen during the study.
- •Not treated with insulin for at least 6 months.
- •Plans to start new lipid modifying therapy or change dose of current lipid modifying therapy during the study.
- •Body mass index (BMI) >45 kg/m^2 or plans to undergo bariatric surgery, weight loss program, or initiate weight loss drugs during the study.
- •History of recent decompensation of diabetes within the prior 2 months (for example, diabetic ketoacidosis).
研究者
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