Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
BANTING
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
2 other identifiers
interventional
424
7 countries
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2016
Shorter than P25 for phase_3
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedStudy Start
First participant enrolled
May 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2017
CompletedResults Posted
Study results publicly available
August 31, 2018
CompletedAugust 31, 2018
August 1, 2018
1.2 years
April 12, 2016
August 2, 2018
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12
Baseline and week 12
Secondary Outcomes (20)
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Baseline and weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Baseline and week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Baseline and weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Baseline and week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Baseline and weeks 10 and 12
- +15 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received placebo subcutaneous injection once every month (QM) for 12 weeks.
Evolocumab
EXPERIMENTALParticipants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
Interventions
Administered by subcutaneous injection with an automated mini doser
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (66)
Research Site
Tuscumbia, Alabama, 35674, United States
Research Site
Phoenix, Arizona, 85012, United States
Research Site
Lomita, California, 90717, United States
Research Site
Los Angeles, California, 90057, United States
Research Site
Roseville, California, 95661, United States
Research Site
San Ramon, California, 94583, United States
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Spring Valley, California, 91978, United States
Research Site
Tarzana, California, 91356, United States
Research Site
Walnut Creek, California, 94598, United States
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Denver, Colorado, 80246, United States
Research Site
Lakewood, Colorado, 80227, United States
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Wilmington, Delaware, 19803, United States
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Boca Raton, Florida, 33434, United States
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Coral Gables, Florida, 33134, United States
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Daytona Beach, Florida, 32117, United States
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Fleming Island, Florida, 32003, United States
Research Site
Hollywood, Florida, 33021, United States
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Inverness, Florida, 34452, United States
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Jacksonville, Florida, 32216, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33136, United States
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West Palm Beach, Florida, 33401, United States
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Dunwoody, Georgia, 30338, United States
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Meridian, Idaho, 83642, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60616, United States
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Louisville, Kentucky, 40213, United States
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Auburn, Maine, 04210, United States
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Scarborough, Maine, 04074, United States
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Salisbury, Maryland, 21804, United States
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Methuen, Massachusetts, 01844, United States
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Bay City, Michigan, 48706, United States
Research Site
Tupelo, Mississippi, 38801, United States
Research Site
Las Vegas, Nevada, 89148, United States
Research Site
Albuquerque, New Mexico, 87106, United States
Research Site
New Windsor, New York, 12553, United States
Research Site
New York, New York, 10016, United States
Research Site
New York, New York, 10029, United States
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Shelby, North Carolina, 28150, United States
Research Site
Tabor City, North Carolina, 28463, United States
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Columbus, Ohio, 43203, United States
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Norman, Oklahoma, 73069, United States
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Austin, Texas, 78749, United States
Research Site
Houston, Texas, 77070, United States
Research Site
Suffolk, Virginia, 23435, United States
Research Site
Edegem, 2650, Belgium
Research Site
Leuven, 3000, Belgium
Research Site
Liège, 4000, Belgium
Research Site
Vancouver, British Columbia, V5Y 3W2, Canada
Research Site
Gatineau, Quebec, J8Y 6S8, Canada
Research Site
Montreal, Quebec, H1Y 3L1, Canada
Research Site
Saint-Jérôme, Quebec, J7Z 5T3, Canada
Research Site
Roma, 00128, Italy
Research Site
Roma, 00133, Italy
Research Site
Verona, 37126, Italy
Research Site
Guadalajara, Jalisco, 44600, Mexico
Research Site
Chihuahua City, 31217, Mexico
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Katowice, 40-040, Poland
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Krakow, 31-315, Poland
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Warsaw, 02-018, Poland
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Wroclaw, 50-306, Poland
Research Site
Almería, Andalusia, 04001, Spain
Research Site
Granada, Andalusia, 18016, Spain
Research Site
Badalona, Catalonia, 08916, Spain
Research Site
Barcelona, Catalonia, 08036, Spain
Related Publications (2)
Rosenson RS, Lopez JAG, Monsalvo ML, Wu Y, Wang H, Marcovina SM. Quantification of LDL-Cholesterol Corrected for Molar Concentration of Lipoprotein(a). Cardiovasc Drugs Ther. 2024 Feb;38(1):191-197. doi: 10.1007/s10557-022-07407-y. Epub 2022 Nov 26.
PMID: 36435949DERIVEDRosenson RS, Daviglus ML, Handelsman Y, Pozzilli P, Bays H, Monsalvo ML, Elliott-Davey M, Somaratne R, Reaven P. Efficacy and safety of evolocumab in individuals with type 2 diabetes mellitus: primary results of the randomised controlled BANTING study. Diabetologia. 2019 Jun;62(6):948-958. doi: 10.1007/s00125-019-4856-7. Epub 2019 Apr 5.
PMID: 30953107DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2016
First Posted
April 15, 2016
Study Start
May 17, 2016
Primary Completion
August 3, 2017
Study Completion
August 3, 2017
Last Updated
August 31, 2018
Results First Posted
August 31, 2018
Record last verified: 2018-08