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

August 2, 2018 updated by: Amgen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
424

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liege, Belgium, 4000
        • Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Research Site
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 6S8
        • Research Site
      • Montreal, Quebec, Canada, H1Y 3L1
        • Research Site
      • St-Jérôme, Quebec, Canada, J7Z 5T3
        • Research Site
  • Italy
      • Roma, Italy, 00128
        • Research Site
      • Roma, Italy, 00133
        • Research Site
      • Verona, Italy, 37126
        • Research Site
  • Mexico
      • Chihuahua, Mexico, 31217
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Research Site
  • Poland
      • Katowice, Poland, 40-040
        • Research Site
      • Krakow, Poland, 31-315
        • Research Site
      • Warszawa, Poland, 02-018
        • Research Site
      • Wroclaw, Poland, 50-306
        • Research Site
  • Spain
    • Andalucía
      • Almeria, Andalucía, Spain, 04001
        • Research Site
      • Granada, Andalucía, Spain, 18016
        • Research Site
    • Cataluña
      • Badalona, Cataluña, Spain, 08916
        • Research Site
      • Barcelona, Cataluña, Spain, 08036
        • Research Site
  • United States
    • Alabama
      • Tuscumbia, Alabama, United States, 35674
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Research Site
    • California
      • Lomita, California, United States, 90717
        • Research Site
      • Los Angeles, California, United States, 90057
        • Research Site
      • Roseville, California, United States, 95661
        • Research Site
      • San Ramon, California, United States, 94583
        • Research Site
      • Spring Valley, California, United States, 91978
        • Research Site
      • Tarzana, California, United States, 91356
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80246
        • Research Site
      • Lakewood, Colorado, United States, 80227
        • Research Site
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Research Site
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Research Site
      • Coral Gables, Florida, United States, 33134
        • Research Site
      • Daytona Beach, Florida, United States, 32117
        • Research Site
      • Fleming Island, Florida, United States, 32003
        • Research Site
      • Hollywood, Florida, United States, 33021
        • Research Site
      • Inverness, Florida, United States, 34452
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Miami, Florida, United States, 33136
        • Research Site
      • Miami, Florida, United States, 33135
        • Research Site
      • West Palm Beach, Florida, United States, 33401
        • Research Site
    • Georgia
      • Dunwoody, Georgia, United States, 30338
        • Research Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Chicago, Illinois, United States, 60611
        • Research Site
      • Chicago, Illinois, United States, 60616
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Research Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Research Site
      • Scarborough, Maine, United States, 04074
        • Research Site
    • Maryland
      • Salisbury, Maryland, United States, 21804
        • Research Site
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • Research Site
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Research Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Research Site
    • New York
      • New Windsor, New York, United States, 12553
        • Research Site
      • New York, New York, United States, 10016
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
    • North Carolina
      • Shelby, North Carolina, United States, 28150
        • Research Site
      • Tabor City, North Carolina, United States, 28463
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43203
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
    • Texas
      • Austin, Texas, United States, 78749
        • Research Site
      • Houston, Texas, United States, 77070
        • Research Site
    • Virginia
      • Suffolk, Virginia, United States, 23435
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12
Time Frame: Baseline and week 12
Baseline and week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and weeks 10 and 12
Baseline and weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Time Frame: Baseline and week 12
Baseline and week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and weeks 10 and 12
Baseline and weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Time Frame: Baseline and week 12
Baseline and week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time Frame: Baseline and weeks 10 and 12
Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame: Baseline and week 12
Baseline and week 12
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Time Frame: Baseline and weeks 10 and 12
Baseline and weeks 10 and 12
Percent Change From Baseline in Total Cholesterol at Week 12
Time Frame: Baseline and week 12
Baseline and week 12
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
Weeks 10 and 12
Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)
Time Frame: Week 12
Week 12
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
Baseline and weeks 10 and 12
Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Time Frame: Baseline and weeks 10 and 12
Baseline and weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12
Time Frame: Baseline and week 12
Baseline and week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time Frame: Baseline and weeks 10 and 12
Baseline and weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Time Frame: Baseline and week 12
Baseline and week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and weeks 10 and 12
Baseline and weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Time Frame: Baseline and week 12
Baseline and week 12
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and weeks 10 and 12
Baseline and weeks 10 and 12
Percent Change From Baseline in VLDL-C at Week 12
Time Frame: Baseline and week 12
Baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 3, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 3, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20130287
  • 2015-004711-21 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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