Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
NCT ID: NCT02662569
Last Updated: 2019-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
986 participants
INTERVENTIONAL
2016-04-14
2017-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Atorvastatin
Administered orally once a day
Placebo
Placebo to evolocumab administered by subcutaneous injection
Atorvastatin (QM)
Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Atorvastatin
Administered orally once a day
Placebo
Placebo to evolocumab administered by subcutaneous injection
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.
Evolocumab
Administered by subcutaneous injection
Atorvastatin
Administered orally once a day
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.
Evolocumab
Administered by subcutaneous injection
Atorvastatin
Administered orally once a day
Interventions
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Evolocumab
Administered by subcutaneous injection
Atorvastatin
Administered orally once a day
Placebo
Placebo to evolocumab administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Type 1 diabetes or poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism.
18 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Miami, Florida, United States
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Atlanta, Georgia, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Overland Park, Kansas, United States
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Monroe, Louisiana, United States
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St Louis, Missouri, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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CABA, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Brasília, Federal District, Brazil
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Goiânia, Goiás, Brazil
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Winnipeg, Manitoba, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Woodstock, Ontario, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Jean-sur-Richelieu, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Beijing, Beijing Municipality, China
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Chongqing, Chongqing Municipality, China
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Nanning, Guangxi, China
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Guiyang, Guizhou, China
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Shijiazhuang, Hebei, China
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Wuhan, Hubei, China
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Wuhan, Hubei, China
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Changsha, Hunan, China
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Changsha, Hunan, China
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Changsha, Hunan, China
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Hengyang, Hunan, China
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Zhuzhou, Hunan, China
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Baotou, Inner Mongolia, China
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Nanjing, Jiangsu, China
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Nanjing, Jiangsu, China
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Nanjing, Jiangsu, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Wuxi, Jiangsu, China
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Xuzhou, Jiangsu, China
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Zhenjiang, Jiangsu, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Changchun, Jilin, China
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Changchun, Jilin, China
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Siping, Jilin, China
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Shenyang, Liaoning, China
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Xi'an, Shaanxi, China
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Jinan, Shandong, China
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Shanghai, Shanghai Municipality, China
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Chengdu, Sichuan, China
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Tianjin, Tianjin Municipality, China
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Ürümqi, Xinjiang, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Linhai, Zhejiang, China
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Wenzhou, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Medellín, Antioquia, Colombia
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Barranquilla, Atlántico, Colombia
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Barranquilla, Atlántico, Colombia
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Barranquilla, Atlántico, Colombia
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Pasto, Departamento de Nariño, Colombia
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Dijon, , France
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Nantes, , France
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Toulouse, , France
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Kemerovo, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Tomsk, , Russia
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Bucheon-si, Wonmi-gu, , South Korea
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Busan, , South Korea
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Busan, , South Korea
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Daegu, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Antalya, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
Countries
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References
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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.
Chen 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-000723-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120119
Identifier Type: -
Identifier Source: org_study_id
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