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

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ClinicalTrials.gov Identifier: NCT02739984
Recruitment Status : Completed
First Posted : April 15, 2016
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Mixed Dyslipidemia Type 2 Diabetes Biological: Evolocumab Drug: Placebo to Evolocumab Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 17, 2016
Actual Primary Completion Date : August 3, 2017
Actual Study Completion Date : August 3, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
Drug: Placebo to Evolocumab
Administered by subcutaneous injection with an automated mini doser

Experimental: Evolocumab
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection with an automated mini doser
Other Names:
  • Repatha
  • AMG 145




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739984


  Show 66 Study Locations
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] January 6, 2016
Statistical Analysis Plan  [PDF] December 22, 2016


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02739984     History of Changes
Other Study ID Numbers: 20130287
2015-004711-21 ( EudraCT Number )
First Posted: April 15, 2016    Key Record Dates
Results First Posted: August 31, 2018
Last Update Posted: August 31, 2018
Last Verified: August 2018
Keywords provided by Amgen:
diabetes
type 2 diabetes
high blood cholesterol
hypercholesterolemia
mixed dyslipidemia
high cholesterol
statin intolerant
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Hypercholesterolemia
Dyslipidemias
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Evolocumab
Antibodies, Monoclonal
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Immunologic Factors
Physiological Effects of Drugs