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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT02739984

Run by

Amgen

People needed

424

Starts

2016-05-17

Expected to finish

2017-08-03

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Lomita, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Roseville, California, United States
• Research Site — San Ramon, California, United States
• Research Site — Spring Valley, California, United States
• Research Site — Tarzana, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Lakewood, Colorado, United States
• Research Site — Wilmington, Delaware, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — Daytona Beach, Florida, United States
• Research Site — Fleming Island, Florida, United States
• Research Site — Hollywood, Florida, United States
• Research Site — Inverness, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Dunwoody, Georgia, United States
• Research Site — Meridian, Idaho, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Tuscumbia, Alabama, United States

Full record on ClinicalTrials.gov

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