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
Overview
- Phase
- Phase 3
- Intervention
- Placebo to Evolocumab
- Conditions
- Hypercholesterolemia
- Sponsor
- Amgen
- Enrollment
- 424
- Locations
- 1
- Primary Endpoint
- Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Placebo
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
Intervention: Placebo to Evolocumab
Evolocumab
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
Intervention: Evolocumab
Outcomes
Primary Outcomes
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12
Time Frame: Baseline and week 12
Secondary Outcomes
- 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)