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

Amgen

Status and phase: Completed; Phase 3

Conditions: Mixed Dyslipidemia; Hypercholesterolemia; Type 2 Diabetes

Treatments: Drug: Placebo to Evolocumab; Biological: Evolocumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02739984

2015-004711-21 (EudraCT Number)

20130287

Details and patient eligibility

About

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.

Full 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.

Enrollment: 424 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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424 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to Evolocumab

Evolocumab

Experimental group

Description:

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

Treatment:

Biological: Evolocumab