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

Last updated: August 2, 2018
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Hypercholesterolemia

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT02739984
20130287
2015-004711-21
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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, coronaryartery bypass graft or stroke within 3 months prior to randomization

Study Design

Total Participants: 424
Study Start date:
May 17, 2016
Estimated Completion Date:
August 03, 2017

Study 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.

Connect with a study center

  • Research Site

    Edegem, 2650
    Belgium

    Site Not Available

  • Research Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Research Site

    Liege, 4000
    Belgium

    Site Not Available

  • Research Site

    Vancouver, British Columbia V5Y 3W2
    Canada

    Site Not Available

  • Research Site

    Gatineau, Quebec J8Y 6S8
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H1Y 3L1
    Canada

    Site Not Available

  • Research Site

    St-Jérôme, Quebec J7Z 5T3
    Canada

    Site Not Available

  • Research Site

    Roma, 00133
    Italy

    Site Not Available

  • Research Site

    Verona, 37126
    Italy

    Site Not Available

  • Research Site

    Guadalajara, Jalisco 44600
    Mexico

    Site Not Available

  • Research Site

    Chihuahua, 31217
    Mexico

    Site Not Available

  • Research Site

    Katowice, 40-040
    Poland

    Site Not Available

  • Research Site

    Krakow, 31-315
    Poland

    Site Not Available

  • Research Site

    Warszawa, 02-018
    Poland

    Site Not Available

  • Research Site

    Wroclaw, 50-306
    Poland

    Site Not Available

  • Research Site

    Almeria, Andalucía 04001
    Spain

    Site Not Available

  • Research Site

    Granada, Andalucía 18016
    Spain

    Site Not Available

  • Research Site

    Badalona, Cataluña 08916
    Spain

    Site Not Available

  • Research Site

    Barcelona, Cataluña 08036
    Spain

    Site Not Available

  • Research Site

    Muscle Shoals, Alabama 35662
    United States

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  • Research Site

    Tuscumbia, Alabama 35674
    United States

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  • Research Site

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Research Site

    Lomita, California 90717
    United States

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  • Research Site

    Los Angeles, California 90057
    United States

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  • Research Site

    Roseville, California 95661
    United States

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    Sacramento, California 95815
    United States

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  • Research Site

    San Ramon, California 94583
    United States

    Site Not Available

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    Spring Valley, California 91978
    United States

    Site Not Available

  • Research Site

    Tarzana, California 91356
    United States

    Site Not Available

  • Research Site

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Research Site

    Denver, Colorado 80246
    United States

    Site Not Available

  • Research Site

    Lakewood, Colorado 80227
    United States

    Site Not Available

  • Research Site

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Research Site

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • Research Site

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Research Site

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • Research Site

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Research Site

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Research Site

    Inverness, Florida 34452
    United States

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    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Research Site

    Miami, Florida 33135
    United States

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    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Research Site

    Dunwoody, Georgia 30338
    United States

    Site Not Available

  • Research Site

    Meridian, Idaho 83642
    United States

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  • Research Site

    Chicago, Illinois 60616
    United States

    Site Not Available

  • Research Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

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    Auburn, Maine 04210
    United States

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    Scarborough, Maine 04074
    United States

    Site Not Available

  • Research Site

    Salisbury, Maryland 21804
    United States

    Site Not Available

  • Research Site

    Methuen, Massachusetts 01844
    United States

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    Bay City, Michigan 48706
    United States

    Site Not Available

  • Research Site

    Tupelo, Mississippi 38801
    United States

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  • Research Site

    Las Vegas, Nevada 89148
    United States

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  • Research Site

    Albuquerque, New Mexico 87106
    United States

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  • Research Site

    New Windsor, New York 12553
    United States

    Site Not Available

  • Research Site

    New York, New York 10029
    United States

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  • Research Site

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • Research Site

    Tabor City, North Carolina 28463
    United States

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  • Research Site

    Columbus, Ohio 43203
    United States

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  • Research Site

    Norman, Oklahoma 73069
    United States

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  • Research Site

    Austin, Texas 78749
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77070
    United States

    Site Not Available

  • Research Site

    Suffolk, Virginia 23435
    United States

    Site Not Available

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