Diabetes, Hyperlipidemia, Mixed DyslipidemiaPhase 3BERSONNCT02662569

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

A Phase 3 study testing Evolocumab and Atorvastatin in people with Diabetes, Hyperlipidemia, Mixed Dyslipidemia, run by Amgen at 110 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes, Hyperlipidemia, Mixed Dyslipidemia
What is being tested?: Evolocumab and Atorvastatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 986 participants
Where: 110 sitesin 10 countries
Study dates: 14 Apr 2016to 6 Dec 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

110 sites in 10 countries.

Country

City, postcode or hospital

110 sites in 10 countries

China47 sites

Research Site
Baotou, Inner Mongolia, 014010
Research Site
Beijing, Beijing Municipality, 100853
Research Site
Beijing, 100029
Research Site
Beijing, 100037
Research Site
Beijing, 100730
Research Site
Changchun, Jilin, 130021
Research Site
Changchun, Jilin, 130033
Research Site
Changchun, Jilin, 130041
Research Site
Changsha, Hunan, 410004
Research Site
Changsha, Hunan, 410008
Research Site
Changsha, Hunan, 410013
Research Site
Chengdu, Sichuan, 610041
Research Site
Chongqing, Chongqing Municipality, 404000
Research Site
Guangzhou, Guangdong, 510080
Research Site
Guangzhou, Guangdong, 510515
Research Site
Guiyang, Guizhou, 550002
Research Site
Hangzhou, Zhejiang, 310003
Research Site
Hangzhou, Zhejiang, 310013
Research Site
Hangzhou, Zhejiang, 310014
Research Site
Hengyang, Hunan, 421001
Research Site
Jinan, Shandong, 250013
Research Site
Linhai, Zhejiang, 318000
Research Site
Nanchang, Jiangxi, 330006
Research Site
Nanjing, Jiangsu, 210008
Research Site
Nanjing, Jiangsu, 210011
Research Site
Nanjing, Jiangsu, 210012
Research Site
Nanjing, Jiangsu, 210029
Research Site
Nanning, Guangxi, 530021
Research Site
Shanghai, Shanghai Municipality, 200032
Research Site
Shanghai, 200003
Research Site
Shanghai, 200040
Research Site
Shanghai, 200080
Research Site
Shanghai, 200120
Research Site
Shenyang, Liaoning, 110004
Research Site
Shijiazhuang, Hebei, 050051
Research Site
Siping, Jilin, 136000
Research Site
Suzhou, Jiangsu, 215021
Research Site
Tianjin, Tianjin Municipality, 300052
Research Site
Ürümqi, Xinjiang, 830054
Research Site
Wenzhou, Zhejiang, 325000
Research Site
Wuhan, Hubei, 430014
Research Site
Wuhan, Hubei, 430030
Research Site
Wuxi, Jiangsu, 214023
Research Site
Xi'an, Shaanxi, 710061
Research Site
Xuzhou, Jiangsu, 221006
Research Site
Zhenjiang, Jiangsu, 212001
Research Site
Zhuzhou, Hunan, 412000

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South Korea13 sites

Research Site
Bucheon-si, Wonmi-gu, 420-717
Research Site
Busan, 602-715
Research Site
Busan, 602-739
Research Site
Daegu, 705-718
Research Site
Seongnam-si, 463-707
Research Site
Seoul, 03722
Research Site
Seoul, 07061
Research Site
Seoul, 110-744
Research Site
Seoul, 110-746
Research Site
Seoul, 130-872
Research Site
Seoul, 137-701
Research Site
Seoul, 139-711
Research Site
Seoul, 152-703

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United States11 sites

Research Site
Atlanta, Georgia, 30328
Research Site
Columbus, Ohio, 43212
Research Site
Dallas, Texas, 75231
Research Site
Dayton, Ohio, 45414
Research Site
Indianapolis, Indiana, 46260
Research Site
Iowa City, Iowa, 52242
Research Site
Miami, Florida, 33173
Research Site
Monroe, Louisiana, 71201
Research Site
Overland Park, Kansas, 66210
Research Site
San Antonio, Texas, 78229
Research Site
St Louis, Missouri, 63141

Other trials in United States

Russia9 sites

Research Site
Kemerovo, 650002
Research Site
Moscow, 117292
Research Site
Moscow, 121552
Research Site
Saint Petersburg, 192289
Research Site
Saint Petersburg, 196601
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 199106
Research Site
Saratov, 410054
Research Site
Tomsk, 634012

Other trials in Russia

Canada8 sites

Research Site
Hamilton, Ontario, L8N 3Z5
Research Site
Laval, Quebec, H7T 2P5
Research Site
London, Ontario, N5W 6A2
Research Site
Montreal, Quebec, H2W 1R7
Research Site
Saint-Jean-sur-Richelieu, Quebec, J3A 1C3
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
Winnipeg, Manitoba, R2H 2A6
Research Site
Woodstock, Ontario, N4S 5P5

Other trials in Canada

Argentina5 sites

Research Site
Buenos Aires, C1425ACG
Research Site
CABA, Buenos Aires, C1405BUB
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR
Research Site
Córdoba, X5003DCE
Research Site
Mar del Plata, Buenos Aires, B7600FZN

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Colombia5 sites

Research Site
Barranquilla, Atlántico, 08001000
Research Site
Barranquilla, Atlántico, 080020
Research Site
Barranquilla, Atlántico
Research Site
Medellín, Antioquia, 050012
Research Site
Pasto, Departamento de Nariño

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Turkey (Türkiye)5 sites

Research Site
Antalya, 07058
Research Site
Istanbul, 34096
Research Site
Istanbul, 34720
Research Site
Izmir, 35000
Research Site
Kocaeli, 41380

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Brazil4 sites

Research Site
Brasília, Federal District, 71625-009
Research Site
Goiânia, Goiás, 74223-130
Research Site
Rio de Janeiro, 22271-100
Research Site
São Paulo, São Paulo, 01244-030

Other trials in Brazil

France3 sites

Research Site
Dijon, 21079
Research Site
Nantes, 44093
Research Site
Toulouse, 31059

Other trials in France

About this study

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)

Conditions: Diabetes, Hyperlipidemia, Mixed Dyslipidemia
Being tested: Evolocumab, Atorvastatin, Placebo
Medical subject headings: Diabetes Mellitus, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EvolocumabBiological
Also called AMG 145, Repatha
Administered by subcutaneous injection
AtorvastatinDrug
Also called Lipitor
Administered orally once a day
PlaceboOther
Placebo to evolocumab administered by subcutaneous injection

Study groups in NCT02662569
Study group	Role	What they receive
Atorvastatin (Q2W)	Active comparator	Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks. Receives: Drug: Atorvastatin; Other: Placebo
Atorvastatin (QM)	Active comparator	Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks. Receives: Drug: Atorvastatin; Other: Placebo
Evolocumab Q2W + Atorvastatin	Experimental	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. Receives: Biological: Evolocumab; Drug: Atorvastatin
Evolocumab QM + Atorvastatin	Experimental	Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. Receives: Biological: Evolocumab; Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12
Measured: Baseline and week 12

Secondary outcomes (21)

Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B100 at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Total Cholesterol at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12
Measured: Baseline and week 12
Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)
Measured: Weeks 10 and 12
Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12
Measured: Week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 20166 Dec 2017

First posted25 Jan 2016 (estimated)
Study start14 Apr 2016
Primary completion6 Dec 2017
Study completion6 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes, Hyperlipidemia, Mixed DyslipidemiaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 986 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02662569
Sponsor's protocol ID: 20120119
Other IDs: 2013-000723-14
Acronym: BERSON
Status last verified: Jan 2019
First submitted: 20 Jan 2016
Last updated: 11 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 32318641
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.
PubMed 30851062

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02662569
Acronym / sponsor ID: BERSON / 20120119
Conditions: Diabetes, Hyperlipidemia, Mixed Dyslipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 986 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 14 Apr 2016 (actual)
Primary completion: 6 Dec 2017 (actual)
Study completion: 6 Dec 2017 (actual)
First posted: 25 Jan 2016 (estimated)
Results: Posted 11 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Atorvastatin (Q2W)	Active comparator	Drug: Atorvastatin, Other: PlaceboParticipants 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 comparator	Drug: Atorvastatin, Other: PlaceboParticipants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Evolocumab Q2W + Atorvastatin	Experimental	Biological: Evolocumab, Drug: AtorvastatinParticipants 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	Experimental	Biological: Evolocumab, Drug: AtorvastatinParticipants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EvolocumabAlso: AMG 145, RepathaAdministered by subcutaneous injection	Biological	Evolocumab Q2W + Atorvastatin, Evolocumab QM + Atorvastatin
AtorvastatinAlso: LipitorAdministered orally once a day	Drug	Atorvastatin (Q2W), Atorvastatin (QM), Evolocumab Q2W + Atorvastatin, Evolocumab QM + Atorvastatin
PlaceboPlacebo to evolocumab administered by subcutaneous injection	Other	Atorvastatin (Q2W), Atorvastatin (QM)

Primary outcome

Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12
Time frame: Baseline and week 12

21 secondary outcomes

Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Time frame: 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
Percent Change From Baseline in Non-HDL-C at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B100 at Week 12
Time frame: 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
Percent Change From Baseline in Total Cholesterol at Week 12
Time frame: 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
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Time frame: 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
Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12
Time frame: Baseline and week 12
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
Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12
Time frame: 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
Percent Change From Baseline in Lipoprotein(a) at Week 12
Time frame: 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
Percent Change From Baseline in Triglycerides at Week 12
Time frame: 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
Percent Change From Baseline in HDL-C at Week 12
Time frame: 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

Results and safety

Results posted to the registry on 11 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Q2W	166	159
Placebo QM	161	160
Evolocumab Q2W	327	321
Evolocumab QM	332	328

Primary outcome: Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

Time frame: Baseline and weeks 10 and 12. Least squares mean (Standard Error). Unit: percent change

Measure	Placebo Q2W n = 164	Placebo QM n = 160	Evolocumab Q2W n = 325	Evolocumab QM n = 332
Value	4.94 (3.48)	0.99 (3.31)	-65.35 (3.09)	-69.05 (2.96)

Placebo Q2W vs Evolocumab Q2W: LS Mean Treatment Difference: -70.29 (95% CI -75.43 to -65.16), p <0.0001, Repeated measures linear effects model
Placebo QM vs Evolocumab QM: LS Mean Treatment Difference: -70.04 (95% CI -74.67 to -65.41), p <0.0001, Repeated measures linear effects model

Population analysed: Full analysis set

Primary outcome: Percent Change From Baseline in LDL-C at Week 12

Time frame: Baseline and week 12. Least squares mean (Standard Error). Unit: percent change

Measure	Placebo Q2W n = 164	Placebo QM n = 160	Evolocumab Q2W n = 325	Evolocumab QM n = 332
Value	7.10 (3.66)	2.63 (3.41)	-64.66 (3.20)	-62.30 (3.02)

Placebo Q2W vs Evolocumab Q2W: LS Mean Treatment Difference: -71.77 (95% CI -77.61 to -65.93), p <0.0001, Repeated measures linear effects model
Placebo QM vs Evolocumab QM: LS Mean Treatment Difference: -64.93 (95% CI -69.97 to -59.89), p <0.0001, Repeated measures linear effects model

Population analysed: Full analysis set

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study drug to 30 days after last dose; up to 14 weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Q2W	6 of 164 (3.7%)	28 of 164 (17.1%)	0 of 164
Placebo QM	5 of 160 (3.1%)	22 of 160 (13.8%)	0 of 160
Evolocumab Q2W	10 of 325 (3.1%)	45 of 325 (13.8%)	0 of 325
Evolocumab QM	22 of 332 (6.6%)	49 of 332 (14.8%)	0 of 332

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32318641Blom 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.
Derived from this study: PubMed 30851062Chen 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

110 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evolocumab and Atorvastatin in people with Diabetes, Hyperlipidemia, Mixed Dyslipidemia, run by Amgen at 110 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in China, South Korea, United States, Russia, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 (time frame: Baseline and weeks 10 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02662569, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (4 listed)

Key exclusion criteria (5 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

Primary outcome: Percent Change From Baseline in LDL-C at Week 12

Adverse events

Research links

Related trials for Diabetes, Hyperlipidemia, Mixed Dyslipidemia

WeArable teChnology daTa driVen digitAl healTh cOachINg (ACTIVATION)- A Mixed-methods Study

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

Primary outcome: Percent Change From Baseline in LDL-C at Week 12

Adverse events