AzTrials
AzTrials

HypercholesterolemiaPhase 3BANTINGNCT02739984

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

A Phase 3 study testing Evolocumab in people with Hypercholesterolemia and Mixed Dyslipidemia, run by Amgen at 66 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Evolocumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
424 participants
Where
66 sitesin 7 countries
Study dates
17 May 2016to 3 Aug 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

66 sites in 7 countries.

66 sites in 7 countries

United States46 sites
  • Research Site

    Albuquerque, New Mexico, 87106

  • Research Site

    Auburn, Maine, 04210

  • Research Site

    Austin, Texas, 78749

  • Research Site

    Bay City, Michigan, 48706

  • Research Site

    Boca Raton, Florida, 33434

  • Research Site

    Chicago, Illinois, 60611

  • Research Site

    Chicago, Illinois, 60612

  • Research Site

    Chicago, Illinois, 60616

  • Research Site

    Columbus, Ohio, 43203

  • Research Site

    Coral Gables, Florida, 33134

  • Research Site

    Daytona Beach, Florida, 32117

  • Research Site

    Denver, Colorado, 80246

  • Research Site

    Dunwoody, Georgia, 30338

  • Research Site

    Fleming Island, Florida, 32003

  • Research Site

    Hollywood, Florida, 33021

  • Research Site

    Houston, Texas, 77070

  • Research Site

    Inverness, Florida, 34452

  • Research Site

    Jacksonville, Florida, 32216

  • Research Site

    Lakewood, Colorado, 80227

  • Research Site

    Las Vegas, Nevada, 89148

  • Research Site

    Lomita, California, 90717

  • Research Site

    Los Angeles, California, 90057

  • Research Site

    Louisville, Kentucky, 40213

  • Research Site

    Meridian, Idaho, 83642

  • Research Site

    Methuen, Massachusetts, 01844

  • Research Site

    Miami, Florida, 33135

  • Research Site

    Miami, Florida, 33136

  • Research Site

    New Windsor, New York, 12553

  • Research Site

    New York, New York, 10016

  • Research Site

    New York, New York, 10029

  • Research Site

    Norman, Oklahoma, 73069

  • Research Site

    Phoenix, Arizona, 85012

  • Research Site

    Roseville, California, 95661

  • Research Site

    Salisbury, Maryland, 21804

  • Research Site

    San Ramon, California, 94583

  • Research Site

    Scarborough, Maine, 04074

  • Research Site

    Shelby, North Carolina, 28150

  • Research Site

    Spring Valley, California, 91978

  • Research Site

    Suffolk, Virginia, 23435

  • Research Site

    Tabor City, North Carolina, 28463

  • Research Site

    Tarzana, California, 91356

  • Research Site

    Tupelo, Mississippi, 38801

  • Research Site

    Tuscumbia, Alabama, 35674

  • Research Site

    Walnut Creek, California, 94598

  • Research Site

    West Palm Beach, Florida, 33401

  • Research Site

    Wilmington, Delaware, 19803

Other trials in United States

Canada4 sites
  • Research Site

    Gatineau, Quebec, J8Y 6S8

  • Research Site

    Montreal, Quebec, H1Y 3L1

  • Research Site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Research Site

    Vancouver, British Columbia, V5Y 3W2

Other trials in Canada

Poland4 sites
  • Research Site

    Katowice, 40-040

  • Research Site

    Krakow, 31-315

  • Research Site

    Warsaw, 02-018

  • Research Site

    Wroclaw, 50-306

Other trials in Poland

Spain4 sites
  • Research Site

    Almería, Andalusia, 04001

  • Research Site

    Badalona, Catalonia, 08916

  • Research Site

    Barcelona, Catalonia, 08036

  • Research Site

    Granada, Andalusia, 18016

Other trials in Spain

Belgium3 sites
  • Research Site

    Edegem, 2650

  • Research Site

    Leuven, 3000

  • Research Site

    Liège, 4000

Other trials in Belgium

Italy3 sites
  • Research Site

    Roma, 00128

  • Research Site

    Roma, 00133

  • Research Site

    Verona, 37126

Other trials in Italy

Mexico2 sites
  • Research Site

    Chihuahua City, 31217

  • Research Site

    Guadalajara, Jalisco, 44600

Other trials in Mexico

About this study

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

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.

Read the 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.

Being tested
Evolocumab, Placebo to Evolocumab
Keywords
diabetes, type 2 diabetes, high blood cholesterol, hypercholesterolemia, mixed dyslipidemia, high cholesterol, statin intolerant
Medical subject headings
Hypercholesterolemia, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EvolocumabBiological

    Also called Repatha, AMG 145

    Administered by subcutaneous injection with an automated mini doser

  • Placebo to EvolocumabDrug

    Administered by subcutaneous injection with an automated mini doser

Study groups in NCT02739984
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received placebo subcutaneous injection once every month (QM) for 12 weeks.
Receives: Drug: Placebo to Evolocumab
EvolocumabExperimentalParticipants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
Receives: Biological: Evolocumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline and Weeks 10 and 12

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

    Measured: Baseline and week 12

Secondary outcomes (20)
  1. Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

    Measured: Baseline and weeks 10 and 12

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

    Measured: Baseline and week 12

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

    Measured: Baseline and weeks 10 and 12

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

    Measured: Baseline and week 12

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

    Measured: Baseline and weeks 10 and 12

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

    Measured: Baseline and week 12

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

    Measured: Baseline and weeks 10 and 12

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

    Measured: 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)

    Measured: Weeks 10 and 12

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

    Measured: Week 12

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

    Measured: Baseline and weeks 10 and 12

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

    Measured: Baseline and Week 12

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

    Measured: Baseline and weeks 10 and 12

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

    Measured: Baseline and week 12

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

    Measured: Baseline and weeks 10 and 12

  16. Percent Change From Baseline in Triglycerides at Week 12

    Measured: Baseline and week 12

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

    Measured: Baseline and weeks 10 and 12

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

    Measured: Baseline and week 12

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

    Measured: Baseline and weeks 10 and 12

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

    Measured: Baseline and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2016 (estimated)
  2. Study start17 May 2016
  3. Primary completion3 Aug 2017
  4. Study completion3 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02739984
Sponsor's protocol ID
20130287
Other IDs
2015-004711-21, 2015
Acronym
BANTING
Status last verified
Aug 2018
First submitted
12 Apr 2016
Last updated
31 Aug 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 36435949
  • Rosenson 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.

    PubMed 30953107

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evolocumab in people with Hypercholesterolemia and Mixed Dyslipidemia, run by Amgen at 66 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Canada, Poland, Spain, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 (time frame: Baseline and Weeks 10 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02739984, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in