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

January 10, 2019 updated by: Amgen

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)

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.

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.

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.
986

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

  • Argentina
      • Buenos Aires, Argentina, C1425ACG
        • Research Site
      • Córdoba, Argentina, X5003DCE
        • Research Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1405BUB
        • Research Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
        • Research Site
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • Research Site
  • Brazil
      • Rio De Janeiro, Brazil, 22271-100
        • Research Site
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 71625-009
        • Research Site
    • Goiás
      • Goiania, Goiás, Brazil, 74223-130
        • Research Site
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 01244-030
        • Research Site
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Research Site
      • London, Ontario, Canada, N5W 6A2
        • Research Site
      • Woodstock, Ontario, Canada, N4S 5P5
        • Research Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Research Site
      • Montreal, Quebec, Canada, H2W 1R7
        • Research Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Research Site
      • St Jean sur Richelieu, Quebec, Canada, J3A 1C3
        • Research Site
  • China
      • Beijing, China, 100730
        • Research Site
      • Beijing, China, 100037
        • Research Site
      • Beijing, China, 100029
        • Research Site
      • Shanghai, China, 200080
        • Research Site
      • Shanghai, China, 200040
        • Research Site
      • Shanghai, China, 200120
        • Research Site
      • Shanghai, China, 200003
        • Research Site
    • Beijing
      • Beijing, Beijing, China, 100853
        • Research Site
    • Chongqing
      • Chongqing, Chongqing, China, 404000
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Research Site
      • Guangzhou, Guangdong, China, 510515
        • Research Site
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Research Site
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Research Site
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Research Site
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Research Site
      • Wuhan, Hubei, China, 430014
        • Research Site
    • Hunan
      • Changsha, Hunan, China, 410008
        • Research Site
      • Changsha, Hunan, China, 410013
        • Research Site
      • Changsha, Hunan, China, 410004
        • Research Site
      • Hengyang, Hunan, China, 421001
        • Research Site
      • Zhuzhou, Hunan, China, 412000
        • Research Site
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Research Site
      • Nanjing, Jiangsu, China, 210008
        • Research Site
      • Nanjing, Jiangsu, China, 210011
        • Research Site
      • Nanjing, Jiangsu, China, 210012
        • Research Site
      • Suzhou, Jiangsu, China, 215021
        • Research Site
      • Wuxi, Jiangsu, China, 214023
        • Research Site
      • Xuzhou, Jiangsu, China, 221006
        • Research Site
      • Zhenjiang, Jiangsu, China, 212001
        • Research Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Research Site
    • Jilin
      • ChangChun, Jilin, China, 130041
        • Research Site
      • Changchun, Jilin, China, 130021
        • Research Site
      • Changchun, Jilin, China, 130033
        • Research Site
      • Siping, Jilin, China, 136000
        • Research Site
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Research Site
    • Shaanxi
      • XI An, Shaanxi, China, 710061
        • Research Site
    • Shandong
      • Jinan, Shandong, China, 250013
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Research Site
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Research Site
    • Xinjiang
      • Urumqi, Xinjiang, China, 830054
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Research Site
      • Hangzhou, Zhejiang, China, 310013
        • Research Site
      • Hangzhou, Zhejiang, China, 310014
        • Research Site
      • Linhai, Zhejiang, China, 318000
        • Research Site
      • Wenzhou, Zhejiang, China, 325000
        • Research Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050012
        • Research Site
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 08001000
        • Research Site
      • Barranquilla, Atlántico, Colombia, 080020
        • Research Site
      • Barranquilla, Atlántico, Colombia
        • Research Site
    • Nariño
      • Pasto, Nariño, Colombia
        • Research Site
  • France
      • Dijon, France, 21079
        • Research Site
      • Nantes Cedex 1, France, 44093
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
  • Korea, Republic of
      • Bucheon-si, Wonmi-gu, Korea, Republic of, 420-717
        • Research Site
      • Busan, Korea, Republic of, 602-715
        • Research Site
      • Busan, Korea, Republic of, 602-739
        • Research Site
      • Daegu, Korea, Republic of, 705-718
        • Research Site
      • Seongnam-si, Korea, Republic of, 463-707
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 139-711
        • Research Site
      • Seoul, Korea, Republic of, 07061
        • Research Site
      • Seoul, Korea, Republic of, 137-701
        • Research Site
      • Seoul, Korea, Republic of, 110-744
        • Research Site
      • Seoul, Korea, Republic of, 152-703
        • Research Site
      • Seoul, Korea, Republic of, 130-872
        • Research Site
      • Seoul, Korea, Republic of, 110-746
        • Research Site
  • Russian Federation
      • Kemerovo, Russian Federation, 650002
        • Research Site
      • Moscow, Russian Federation, 121552
        • Research Site
      • Moscow, Russian Federation, 117292
        • Research Site
      • Saint-Petersburg, Russian Federation, 197022
        • Research Site
      • Saint-Petersburg, Russian Federation, 199106
        • Research Site
      • Saint-Petersburg, Russian Federation, 196601
        • Research Site
      • Saint-Petersburg, Russian Federation, 192289
        • Research Site
      • Saratov, Russian Federation, 410054
        • Research Site
      • Tomsk, Russian Federation, 634012
        • Research Site
  • Turkey
      • Antalya, Turkey, 07058
        • Research Site
      • Istanbul, Turkey, 34096
        • Research Site
      • Istanbul, Turkey, 34720
        • Research Site
      • Izmir, Turkey, 35000
        • Research Site
      • Kocaeli, Turkey, 41380
        • Research Site
  • United States
    • Florida
      • Miami, Florida, United States, 33173
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Research Site
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Research Site
      • Dayton, Ohio, United States, 45414
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Site
      • San Antonio, Texas, United States, 78229
        • 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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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 Assignment
  • Masking: Quadruple

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.
Active Comparator: Atorvastatin (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Other: Placebo
Placebo to evolocumab administered by subcutaneous injection
Active Comparator: Atorvastatin (QM)
Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Other: Placebo
Placebo to evolocumab administered by subcutaneous injection
Experimental: Evolocumab Q2W + Atorvastatin
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Experimental: Evolocumab QM + Atorvastatin
Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor

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 Week 12
Time Frame: Baseline and week 12
Baseline and week 12
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

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
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
Weeks 10 and 12
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 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
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 Apolipoprotein B100 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 B100 at Week 12
Time Frame: Baseline and week 12
Baseline and week 12
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
Baseline and weeks 10 and 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Time Frame: Baseline and week 12
Baseline and week 12
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
Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12
Time Frame: Baseline and week 12
Baseline and week 12
Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12
Time Frame: Week 12
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.
April 14, 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.
December 6, 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.
December 6, 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).
January 20, 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.
January 20, 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.
January 25, 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.
January 11, 2019

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.
January 10, 2019

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.
January 1, 2019

More Information

Terms related to this study

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.
  • 20120119
  • 2013-000723-14 (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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