Clinical trial NCT02662569: Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes, Hyperlipidemia, Mixed Dyslipidemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-01-25
Enrollment: 986
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in LDL-C at Week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Change From Baseline in LDL-C at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Non-HDL-C at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Apolipoprotein B100 at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Total Cholesterol at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12
timeFrame: Baseline and week 12
measure: Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)
timeFrame: Weeks 10 and 12
measure: Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12
timeFrame: Week 12
measure: Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Lipoprotein(a) at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Triglycerides at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in HDL-C at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Iowa City
country: United States
facility: Research Site
state: Iowa
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Monroe
country: United States
facility: Research Site
state: Louisiana
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Caba
country: Argentina
facility: Research Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Research Site
city: Córdoba
country: Argentina
facility: Research Site
city: Brasília
country: Brazil
facility: Research Site
state: Distrito Federal
city: Goiania
country: Brazil
facility: Research Site
state: Goiás
city: Sao Paulo
country: Brazil
facility: Research Site
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Research Site
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Woodstock
country: Canada
facility: Research Site
state: Ontario
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: St Jean sur Richelieu
country: Canada
facility: Research Site
state: Quebec
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Nanning
country: China
facility: Research Site
state: Guangxi
city: Guiyang
country: China
facility: Research Site
state: Guizhou
city: Shijiazhuang
country: China
facility: Research Site
state: Hebei
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Hengyang
country: China
facility: Research Site
state: Hunan
city: Zhuzhou
country: China
facility: Research Site
state: Hunan
city: Baotou
country: China
facility: Research Site
state: Inner Mongolia
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Suzhou
country: China
facility: Research Site
state: Jiangsu
city: Wuxi
country: China
facility: Research Site
state: Jiangsu
city: Xuzhou
country: China
facility: Research Site
state: Jiangsu
city: Zhenjiang
country: China
facility: Research Site
state: Jiangsu
city: Nanchang
country: China
facility: Research Site
state: Jiangxi
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Changchun
country: China
facility: Research Site
state: Jilin
city: ChangChun
country: China
facility: Research Site
state: Jilin
city: Siping
country: China
facility: Research Site
state: Jilin
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: XI An
country: China
facility: Research Site
state: Shaanxi
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Urumqi
country: China
facility: Research Site
state: Xinjiang
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Linhai
country: China
facility: Research Site
state: Zhejiang
city: Wenzhou
country: China
facility: Research Site
state: Zhejiang
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Research Site
state: Atlántico
city: Barranquilla
country: Colombia
facility: Research Site
state: Atlántico
city: Barranquilla
country: Colombia
facility: Research Site
state: Atlántico
city: Pasto
country: Colombia
facility: Research Site
state: Nariño
city: Dijon
country: France
facility: Research Site
city: Nantes Cedex 1
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
facility: Research Site
city: Bucheon-si, Wonmi-gu
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.