Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

Phase 3

Completed

• Conditions: Type 2 Diabetes; Hypercholesterolemia; Mixed Dyslipidemia
• Interventions: Drug: Placebo to Evolocumab; Biological: Evolocumab

• Registration Number: NCT02739984
• Lead Sponsor: Amgen

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.

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Study Start: 2016-05-17
• Primary Completion: 2017-08-03
• Study Completion: 2017-08-03
• Status Verified: 2018-08
• Results First Submitted: 2018-08-02
• Results First Submitted QC: 2018-08-02
• Last Update Submitted: 2018-08-02
• Results First Posted: 2018-08-31
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo to Evolocumab	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
Evolocumab	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percent 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 LDL-C at Week 12	Baseline and week 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇪🇸 Barcelona, Cataluña, Spain