A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Evolocumab (AMG 145) on LDL-C in Subjects With Type 2 Diabetes Mellitus and Hypercholesterolemia/Mixed Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
研究概览
简要总结
The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.
详细描述
This study will enroll adults with type 2 diabetes mellitus and elevated LDL-C or non-high-density lipoprotein cholesterol (non-HDL-C) levels on a stable, maximally tolerated statin dose of at least moderate-intensity at signing of the informed consent; statin therapy must remain unchanged during screening and the remainder of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years
- •Type 2 Diabetes Mellitus
- •Hemoglobin A1c < 10%
- •Stable diabetes therapy
- •Must be on maximally tolerated dose of statin of at least moderate Intensity
- •Fasting triglycerides ≤ 600 mg/dL
- •Not at LDL-C or Non-HDL-C goal.
排除标准
- •Moderate to severe renal dysfunction
- •Uncontrolled hypertension
- •Persistent active liver disease or hepatic dysfunction
- •Has taken a cholesterylester transfer protein inhibitor in the last 12 months,
- •Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months prior to randomization
研究组 & 干预措施
Placebo
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
干预措施: Placebo to Evolocumab (Drug)
Evolocumab
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
干预措施: Evolocumab (Biological)
结局指标
主要结局
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
时间窗: Baseline and Weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12
时间窗: Baseline and week 12
次要结局
- Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Percent Change From Baseline in Apolipoprotein B at Week 12(Baseline and week 12)
- Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Percent Change From Baseline in Total Cholesterol at Week 12(Baseline and week 12)
- Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)(Weeks 10 and 12)
- Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)(Week 12)
- Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12(Baseline and weeks 10 and 12)
- Change From Baseline in LDL-C at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Change From Baseline in LDL-C at Week 12(Baseline and week 12)
- Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Percent Change From Baseline in Non-HDL-C at Week 12(Baseline and week 12)
- Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Percent Change From Baseline in Lipoprotein(a) at Week 12(Baseline and week 12)
- Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Percent Change From Baseline in Triglycerides at Week 12(Baseline and week 12)
- Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Percent Change From Baseline in HDL-C at Week 12(Baseline and week 12)
- Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Percent Change From Baseline in VLDL-C at Week 12(Baseline and week 12)