EUCTR2016-001176-30-FI进行中（未招募）1 期
Effects of PCSK9 inhibition by Evolocumab on postprandial lipid metabolism in type 2 diabetes - EVOLKI
Clinical Research Institute, HUCH Ltd.0 个研究点目标入组 20 人开始时间: 2016年4月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •- Male or female (non-fertile or using a medically approved birth control method)
- •overweight/obese subjects with T2D treated with lifestyle counselling and a stable
- •metformin dose for at least three months
- •- age 18–77 yrs.
- •- BMI 25–40 kg/m2
- •- triglycerides between 1.5–4.5 mmol/L and LDL cholesterol >1.8 but =4.0 mmol/L (on
- •Atorvastatin 20 mg/day)
- •- HbA1c: =9%.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Type 1 diabetes
- •- apoE2/2 phenotype
- •- ALT/AST > 3×ULN
- •- CK>3×UNL
- •- GFR <60 ml/min
- •- clinically significant TSH outside the normal range
- •- BMI >40 kg/m2
- •- HbA1C > 9.0 %
- •- fasting TG > 4.5 mmol/l
- •- total chol > 7.0 mmol/l
- •- positive urine or serum pregnancy test
- •- untreated or inadequately treated hypertension defined as blood pressure >160 mmHg
- •systolic and/or >105 mmHg diastolic, use of thiazide diuretics at a dose of =25 mg/day
- •- subject not on a stable dose of atorvastatin (20 mg/ day before randomization)
- •- lipid-lowering drugs other than statins within 3 months
- •- any other diabetes medication except diet + metformin
- •- history/diagnosis of diabetes nephropathy / retinopathy
- •- weekly alcohol use over 24 doses for men and 16 for women
- •- history of MI, ACS or coronary revascularization (PCI or CABG) within the last 6 mos.
- •- NYHA class III/IV congestive heart failure persisting despite treatment
- •- history of hemorrhagic stroke
- •- hypersensitivity to any of the excipients found in the drug product
- •- use of estrogen therapy
- •- current use of antithrombotic or anticoagulant therapy
- •- known bleeding tendency that would be an contraindication to heparin test
- •- history of cancer within the past 5 years (except for adequately treated basal cell skin
- •cancer, squamous cell skin cancer or in situ cervical cancer)
- •- women of childbearing potential not protected by effective birth control method and/or
- •not willing to be tested for pregnancy
- •- patient considered by the investigator or any sub-investigator as inappropriate for this
- •study for any reason
研究者
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