Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
BERSON
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)
2 other identifiers
interventional
986
10 countries
110
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2016
110 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
January 20, 2016
CompletedFirst Posted
Study publicly available on registry
January 25, 2016
CompletedStudy Start
First participant enrolled
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2017
CompletedResults Posted
Study results publicly available
January 11, 2019
CompletedJanuary 11, 2019
January 1, 2019
1.6 years
January 20, 2016
November 30, 2018
January 10, 2019
Conditions
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 (21)
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 B100 at the Mean of Weeks 10 and 12
Baseline and weeks 10 and 12
- +16 more secondary outcomes
Study Arms (4)
Atorvastatin (Q2W)
ACTIVE COMPARATORParticipants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Atorvastatin (QM)
ACTIVE COMPARATORParticipants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Evolocumab Q2W + Atorvastatin
EXPERIMENTALParticipants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
Evolocumab QM + Atorvastatin
EXPERIMENTALParticipants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
Interventions
Administered by subcutaneous injection
Administered orally once a day
Placebo to evolocumab administered by subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (110)
Research Site
Miami, Florida, 33173, United States
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Atlanta, Georgia, 30328, United States
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Indianapolis, Indiana, 46260, United States
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Iowa City, Iowa, 52242, United States
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Overland Park, Kansas, 66210, United States
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Monroe, Louisiana, 71201, United States
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St Louis, Missouri, 63141, United States
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Columbus, Ohio, 43212, United States
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Dayton, Ohio, 45414, United States
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Dallas, Texas, 75231, United States
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San Antonio, Texas, 78229, United States
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CABA, Buenos Aires, C1405BUB, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR, Argentina
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Mar del Plata, Buenos Aires, B7600FZN, Argentina
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Buenos Aires, C1425ACG, Argentina
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Córdoba, X5003DCE, Argentina
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Brasília, Federal District, 71625-009, Brazil
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Goiânia, Goiás, 74223-130, Brazil
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São Paulo, São Paulo, 01244-030, Brazil
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Rio de Janeiro, 22271-100, Brazil
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Winnipeg, Manitoba, R2H 2A6, Canada
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Hamilton, Ontario, L8N 3Z5, Canada
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London, Ontario, N5W 6A2, Canada
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Woodstock, Ontario, N4S 5P5, Canada
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Laval, Quebec, H7T 2P5, Canada
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Montreal, Quebec, H2W 1R7, Canada
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Saint-Jean-sur-Richelieu, Quebec, J3A 1C3, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Beijing, Beijing Municipality, 100853, China
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Chongqing, Chongqing Municipality, 404000, China
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Guangzhou, Guangdong, 510080, China
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Guangzhou, Guangdong, 510515, China
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Nanning, Guangxi, 530021, China
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Guiyang, Guizhou, 550002, China
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Shijiazhuang, Hebei, 050051, China
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Wuhan, Hubei, 430014, China
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Wuhan, Hubei, 430030, China
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Changsha, Hunan, 410004, China
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Changsha, Hunan, 410008, China
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Changsha, Hunan, 410013, China
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Hengyang, Hunan, 421001, China
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Zhuzhou, Hunan, 412000, China
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Baotou, Inner Mongolia, 014010, China
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Nanjing, Jiangsu, 210008, China
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Nanjing, Jiangsu, 210011, China
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Nanjing, Jiangsu, 210012, China
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Nanjing, Jiangsu, 210029, China
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Suzhou, Jiangsu, 215021, China
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Wuxi, Jiangsu, 214023, China
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Xuzhou, Jiangsu, 221006, China
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Zhenjiang, Jiangsu, 212001, China
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Nanchang, Jiangxi, 330006, China
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Changchun, Jilin, 130021, China
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Changchun, Jilin, 130033, China
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Changchun, Jilin, 130041, China
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Siping, Jilin, 136000, China
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Shenyang, Liaoning, 110004, China
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Xi'an, Shaanxi, 710061, China
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Jinan, Shandong, 250013, China
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Shanghai, Shanghai Municipality, 200032, China
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Chengdu, Sichuan, 610041, China
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Tianjin, Tianjin Municipality, 300052, China
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Ürümqi, Xinjiang, 830054, China
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Hangzhou, Zhejiang, 310003, China
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Hangzhou, Zhejiang, 310013, China
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Hangzhou, Zhejiang, 310014, China
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Linhai, Zhejiang, 318000, China
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Wenzhou, Zhejiang, 325000, China
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Beijing, 100029, China
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Beijing, 100037, China
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Beijing, 100730, China
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Shanghai, 200003, China
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Shanghai, 200040, China
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Shanghai, 200080, China
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Shanghai, 200120, China
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Medellín, Antioquia, 050012, Colombia
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Barranquilla, Atlántico, 08001000, Colombia
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Barranquilla, Atlántico, 080020, Colombia
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Barranquilla, Atlántico, Colombia
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Pasto, Departamento de Nariño, Colombia
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Dijon, 21079, France
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Nantes, 44093, France
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Toulouse, 31059, France
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Kemerovo, 650002, Russia
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Moscow, 117292, Russia
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Moscow, 121552, Russia
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Saint Petersburg, 192289, Russia
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Saint Petersburg, 196601, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 199106, Russia
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Saratov, 410054, Russia
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Tomsk, 634012, Russia
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Bucheon-si, Wonmi-gu, 420-717, South Korea
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Busan, 602-715, South Korea
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Busan, 602-739, South Korea
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Daegu, 705-718, South Korea
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Seongnam-si, 463-707, South Korea
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Seoul, 03722, South Korea
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Seoul, 07061, South Korea
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Seoul, 110-744, South Korea
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Seoul, 110-746, South Korea
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Seoul, 130-872, South Korea
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Seoul, 137-701, South Korea
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Seoul, 139-711, South Korea
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Seoul, 152-703, South Korea
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Antalya, 07058, Turkey (Türkiye)
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Istanbul, 34096, Turkey (Türkiye)
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Istanbul, 34720, Turkey (Türkiye)
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Izmir, 35000, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
Related Publications (2)
Blom DJ, Chen J, Yuan Z, Borges JLC, Monsalvo ML, Wang N, Hamer AW, Ge J. Effects of evolocumab therapy and low LDL-C levels on vitamin E and steroid hormones in Chinese and global patients with type 2 diabetes. Endocrinol Diabetes Metab. 2020 Mar 6;3(2):e00123. doi: 10.1002/edm2.123. eCollection 2020 Apr.
PMID: 32318641DERIVEDChen Y, Yuan Z, Lu J, Eliaschewitz FG, Lorenzatti AJ, Monsalvo ML, Wang N, Hamer AW, Ge J. Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre-specified analysis of the Chinese population from the BERSON clinical trial. Diabetes Obes Metab. 2019 Jun;21(6):1464-1473. doi: 10.1111/dom.13700. Epub 2019 Apr 14.
PMID: 30851062DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2016
First Posted
January 25, 2016
Study Start
April 14, 2016
Primary Completion
December 6, 2017
Study Completion
December 6, 2017
Last Updated
January 11, 2019
Results First Posted
January 11, 2019
Record last verified: 2019-01