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OpenTrials
Completed

NCT Number: NCT02739984

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

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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Key information

Conditions

Hypercholesterolemia Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Mixed Dyslipidemia Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Edegem, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evolocumab

Biological

Administered by subcutaneous injection with an automated mini doser

Other names: Repatha, AMG 145

Placebo to Evolocumab

Drug

Administered by subcutaneous injection with an automated mini doser

Primary outcomes

  1. Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  2. Percent Change From Baseline in LDL-C at Week 12

    Time frame: Baseline and week 12

Secondary outcomes

  1. Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  2. Change From Baseline in LDL-C at Week 12

    Time frame: Baseline and week 12

  3. Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  4. Percent Change From Baseline in Non-HDL-C at Week 12

    Time frame: Baseline and week 12

  5. Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  6. Percent Change From Baseline in Apolipoprotein B at Week 12

    Time frame: Baseline and week 12

  7. Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  8. Percent Change From Baseline in Total Cholesterol at Week 12

    Time frame: Baseline and week 12

  9. Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)

    Time frame: Weeks 10 and 12

  10. Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)

    Time frame: Week 12

  11. Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  12. Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12

    Time frame: Baseline and Week 12

  13. Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  14. Percent Change From Baseline in Lipoprotein(a) at Week 12

    Time frame: Baseline and week 12

  15. Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  16. Percent Change From Baseline in Triglycerides at Week 12

    Time frame: Baseline and week 12

  17. Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  18. Percent Change From Baseline in HDL-C at Week 12

    Time frame: Baseline and week 12

  19. Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  20. Percent Change From Baseline in VLDL-C at Week 12

    Time frame: Baseline and week 12

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Evolocumab (AMG 145) on LDL-C in Subjects With Type 2 Diabetes Mellitus and Hypercholesterolemia/Mixed Dyslipidemia

Acronym: BANTING

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 15, 2016
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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