A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Diabetic Subjects With Hyperlipidemia or Mixed Dyslipidemia (BERSON)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 986
- 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 primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females with type 2 diabetes (receiving pharmacologic treatment for at least 6 months or longer) with stable diabetes therapy
- •Lipid-lowering therapy must be unchanged for at least 4 weeks or more
- •Subjects receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 100 mg/dL
- •Subjects not receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 130 mg/dL
- •Exclusion criteria:
- •New York Heart Association (NYHA) class III or IV heart failure
- •Uncontrolled cardiac arrhythmia
- •Uncontrolled hypertension
- •Type 1 diabetes or poorly controlled type 2 diabetes
- •Uncontrolled hypothyroidism or hyperthyroidism.
排除标准
- 未提供
研究组 & 干预措施
Atorvastatin (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
干预措施: Atorvastatin (Drug)
Atorvastatin (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
干预措施: Placebo (Other)
Atorvastatin (QM)
Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
干预措施: Atorvastatin (Drug)
Atorvastatin (QM)
Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
干预措施: Placebo (Other)
Evolocumab Q2W + Atorvastatin
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
干预措施: Evolocumab (Biological)
Evolocumab Q2W + Atorvastatin
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
干预措施: Atorvastatin (Drug)
Evolocumab QM + Atorvastatin
Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
干预措施: Evolocumab (Biological)
Evolocumab QM + Atorvastatin
Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
干预措施: Atorvastatin (Drug)
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 Total Cholesterol at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)(Weeks 10 and 12)
- Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12(Baseline and week 12)
- Change From Baseline in LDL-C at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 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)
- Percent Change From Baseline in VLDL-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 Apolipoprotein B100 at the Mean of Weeks 10 and 12(Baseline and weeks 10 and 12)
- Percent Change From Baseline in Apolipoprotein B100 at Week 12(Baseline and week 12)
- Percent Change From Baseline in Total Cholesterol at Week 12(Baseline and week 12)
- Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12(Baseline and week 12)
- Percent Change From Baseline in HDL-C at Week 12(Baseline and week 12)
- Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12(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)