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Evaluation of Evolocumab (AMG...

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

Last Updated: 2018-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

424 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-17

Study Completion Date

2017-08-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypercholesterolemia Mixed Dyslipidemia Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo to Evolocumab

Intervention Type DRUG

Administered by subcutaneous injection with an automated mini doser

Evolocumab

Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection with an automated mini doser

Interventions

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Evolocumab

Administered by subcutaneous injection with an automated mini doser

Intervention Type BIOLOGICAL

Placebo to Evolocumab

Administered by subcutaneous injection with an automated mini doser

Intervention Type DRUG

Other Intervention Names

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Repatha AMG 145

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers