Back to resultsSafety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia (BERSON)
Primary Purpose
Diabetes, Hyperlipidemia, Mixed Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Atorvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes, Hyperlipidemia, 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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
Atorvastatin (Q2W)
Atorvastatin (QM)
Evolocumab Q2W + Atorvastatin
Evolocumab QM + Atorvastatin
Arm Description
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
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.
Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12
Secondary Outcome Measures
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B100 at Week 12
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Percent Change From Baseline in Total Cholesterol at Week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12
Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)
Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02662569
Brief Title
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
Acronym
BERSON
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 14, 2016 (Actual)
Primary Completion Date
December 6, 2017 (Actual)
Study Completion Date
December 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hyperlipidemia, Mixed Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
986 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin (Q2W)
Arm Type
Active Comparator
Arm Description
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Arm Title
Atorvastatin (QM)
Arm Type
Active Comparator
Arm Description
Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Arm Title
Evolocumab Q2W + Atorvastatin
Arm Type
Experimental
Arm Description
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.
Arm Title
Evolocumab QM + Atorvastatin
Arm Type
Experimental
Arm Description
Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
Administered orally once a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo to evolocumab administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in LDL-C at Week 12
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Change From Baseline in LDL-C at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in Non-HDL-C at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in Apolipoprotein B100 at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in Total Cholesterol at Week 12
Time Frame
Baseline and week 12
Title
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
Title
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Time Frame
Baseline and week 12
Title
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
Title
Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12
Time Frame
Baseline and week 12
Title
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
Title
Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12
Time Frame
Week 12
Title
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in Lipoprotein(a) at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in Triglycerides at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in HDL-C at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Research Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Research Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1405BUB
Country
Argentina
Facility Name
Research Site
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1425ACG
Country
Argentina
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Research Site
City
Brasília
State/Province
Distrito Federal
ZIP/Postal Code
71625-009
Country
Brazil
Facility Name
Research Site
City
Goiania
State/Province
Goiás
ZIP/Postal Code
74223-130
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
Research Site
City
Rio De Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Research Site
City
Woodstock
State/Province
Ontario
ZIP/Postal Code
N4S 5P5
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Research Site
City
St Jean sur Richelieu
State/Province
Quebec
ZIP/Postal Code
J3A 1C3
Country
Canada
Facility Name
Research Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Research Site
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Research Site
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Research Site
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550002
Country
China
Facility Name
Research Site
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430014
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Research Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410004
Country
China
Facility Name
Research Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Research Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Research Site
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Facility Name
Research Site
City
Zhuzhou
State/Province
Hunan
ZIP/Postal Code
412000
Country
China
Facility Name
Research Site
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210012
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Research Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215021
Country
China
Facility Name
Research Site
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
Research Site
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221006
Country
China
Facility Name
Research Site
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Facility Name
Research Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Research Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Research Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130033
Country
China
Facility Name
Research Site
City
ChangChun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
Research Site
City
Siping
State/Province
Jilin
ZIP/Postal Code
136000
Country
China
Facility Name
Research Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Research Site
City
XI An
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Research Site
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Research Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Research Site
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310013
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Research Site
City
Linhai
State/Province
Zhejiang
ZIP/Postal Code
318000
Country
China
Facility Name
Research Site
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Research Site
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050012
Country
Colombia
Facility Name
Research Site
City
Barranquilla
State/Province
Atlántico
ZIP/Postal Code
08001000
Country
Colombia
Facility Name
Research Site
City
Barranquilla
State/Province
Atlántico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Research Site
City
Barranquilla
State/Province
Atlántico
Country
Colombia
Facility Name
Research Site
City
Pasto
State/Province
Nariño
Country
Colombia
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Research Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Research Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Research Site
City
Bucheon-si, Wonmi-gu
ZIP/Postal Code
420-717
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
139-711
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
192289
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
196601
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Facility Name
Research Site
City
Antalya
ZIP/Postal Code
07058
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34720
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35000
Country
Turkey
Facility Name
Research Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
32318641
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.
Results Reference
derived
PubMed Identifier
30851062
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
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