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OpenTrials
Completed

NCT Number: NCT02662569

Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia

The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females with type 2 diabetes (receiving pharmacologic treatment for at least 6 months or longer) with stable diabetes therapy
  • Lipid-lowering therapy must be unchanged for at least 4 weeks or more
  • Subjects receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 100 mg/dL
  • Subjects not receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 130 mg/dL

Exclusion criteria

  • New York Heart Association (NYHA) class III or IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Type 1 diabetes or poorly controlled type 2 diabetes
  • Uncontrolled hypothyroidism or hyperthyroidism.

Treatment and study plan

Evolocumab

Biological

Administered by subcutaneous injection

Other names: AMG 145, Repatha

atorvastatin

Drug

Administered orally once a day

Other names: Lipitor

Placebo

Other

Placebo to evolocumab administered by subcutaneous injection

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 B100 at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  6. Percent Change From Baseline in Apolipoprotein B100 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. Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  10. Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12

    Time frame: Baseline and week 12

  11. Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  12. Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12

    Time frame: Baseline and week 12

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

    Time frame: Weeks 10 and 12

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

    Time frame: Week 12

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

    Time frame: Baseline and weeks 10 and 12

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

    Time frame: Baseline and week 12

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

    Time frame: Baseline and weeks 10 and 12

  18. Percent Change From Baseline in Triglycerides at Week 12

    Time frame: Baseline and week 12

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

    Time frame: Baseline and weeks 10 and 12

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

    Time frame: Baseline and week 12

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

    Time frame: Baseline and weeks 10 and 12

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Diabetic Subjects With Hyperlipidemia or Mixed Dyslipidemia (BERSON)

Acronym: BERSON

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2016
Registry last updated
Jan 11, 2019

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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