Effects of PCSK9 Inhibition by Evolocumab on Postprandial Lipid Metabolism in Type 2 Diabetes
NCT ID: NCT02948777
Last Updated: 2021-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
14 participants
INTERVENTIONAL
2016-10-31
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Evolocumab
Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks
Evolocumab
Interventions
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Evolocumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-77 yrs.
* body mass index 25-40 kg/m2
* triglycerides between 1.5-4.5 mmol/L and low-density-lipoprotein cholesterol \>1.8 but ≤4.0 mmol/L (on Atorvastatin 20 mg/day)
* glycohemoglobin: ≤9%.
Exclusion Criteria
* apolipoprotein E2/2 phenotype
* alanine transaminase / aspartate transaminase \> 3× upper limit of normal
* creatinine kinase\>3× upper limit of normal
* glomerular filtration rate \<60 ml/min
* clinically significant thyroid-stimulating hormone outside the normal range
* body mass index \>40 kg/m2
* glycohemoglobin \> 9.0 %
* fasting triglycerides \> 4.5 mmol/l
* total cholesterol \> 7.0 mmol/l
* positive urine or serum pregnancy test
* untreated or inadequately treated hypertension defined as blood pressure \>160 mmHg systolic and/or \>105 mmHg diastolic, use of thiazide diuretics at a dose of ≥25 mg/day
* subject not on a stable dose of atorvastatin (20 mg/ day before randomization)
* lipid-lowering drugs other than statins within 3 months
* any other diabetes medication except diet + metformin
* history/diagnosis of diabetes nephropathy / retinopathy
* current smoking
* weekly alcohol use over 24 doses for men and 16 for women
* history of myocardial infarction, acute coronary syndrome or coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within the last 6 mos.
* planned revascularization (eg coronary artery bypass grafting, percutaneous coronary intervention, carotid or peripheral revascularization procedures) within 3 months of screening
* New York Heart Association class III/IV congestive heart failure persisting despite treatment
* history of hemorrhagic stroke
* hypersensitivity to (evolocumab or) any of the excipients found in the drug product
* use of estrogen therapy
* current use of antithrombotic or anticoagulant therapy
* known bleeding tendency that would be an contraindication to heparin test
* history of cancer within the past 5 years (except for adequately treated basal cell skin cancer, squamous cell skin cancer or in situ cervical cancer)
* women of childbearing potential not protected by effective birth control method and/or not willing to be tested for pregnancy
* patient considered by the investigator or any sub-investigator as inappropriate for this study for any reason
18 Years
77 Years
ALL
No
Sponsors
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Göteborg University
OTHER
Marja-Riitta Taskinen
OTHER
Responsible Party
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Marja-Riitta Taskinen
Professor, emerita
Principal Investigators
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Marja-Riitta Taskinen, Prof., PI
Role: PRINCIPAL_INVESTIGATOR
Clinical Research institute Huch, Ltd and University of Helsinki
Jan Boren, Prof., co-PI
Role: PRINCIPAL_INVESTIGATOR
University of Gothenburg and Sahlgrenska University Hospital
Locations
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Helsinki University Hospital, Biomedicum 2U
Helsinki, , Finland
Countries
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References
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Taskinen MR, Bjornson E, Kahri J, Soderlund S, Matikainen N, Porthan K, Ainola M, Hakkarainen A, Lundbom N, Fermanelli V, Fuchs J, Thorsell A, Kronenberg F, Andersson L, Adiels M, Packard CJ, Boren J. Effects of Evolocumab on the Postprandial Kinetics of Apo (Apolipoprotein) B100- and B48-Containing Lipoproteins in Subjects With Type 2 Diabetes. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):962-975. doi: 10.1161/ATVBAHA.120.315446. Epub 2020 Dec 24.
Taskinen MR, Bjornson E, Andersson L, Kahri J, Porthan K, Matikainen N, Soderlund S, Pietilainen K, Hakkarainen A, Lundbom N, Nilsson R, Stahlman M, Adiels M, Parini P, Packard C, Boren J. Impact of proprotein convertase subtilisin/kexin type 9 inhibition with evolocumab on the postprandial responses of triglyceride-rich lipoproteins in type II diabetic subjects. J Clin Lipidol. 2020 Jan-Feb;14(1):77-87. doi: 10.1016/j.jacl.2019.12.003. Epub 2019 Dec 12.
Zech LA, Grundy SM, Steinberg D, Berman M. Kinetic model for production and metabolism of very low density lipoprotein triglycerides. Evidence for a slow production pathway and results for normolipidemic subjects. J Clin Invest. 1979 Jun;63(6):1262-73. doi: 10.1172/JCI109421.
Bjornson E, Packard CJ, Adiels M, Andersson L, Matikainen N, Soderlund S, Kahri J, Sihlbom C, Thorsell A, Zhou H, Taskinen MR, Boren J. Investigation of human apoB48 metabolism using a new, integrated non-steady-state model of apoB48 and apoB100 kinetics. J Intern Med. 2019 May;285(5):562-577. doi: 10.1111/joim.12877. Epub 2019 Mar 12.
Taskinen MR, Matikainen N, Bjornson E, Soderlund S, Inkeri J, Hakkarainen A, Parviainen H, Sihlbom C, Thorsell A, Andersson L, Adiels M, Packard CJ, Boren J. Contribution of intestinal triglyceride-rich lipoproteins to residual atherosclerotic cardiovascular disease risk in individuals with type 2 diabetes on statin therapy. Diabetologia. 2023 Dec;66(12):2307-2319. doi: 10.1007/s00125-023-06008-0. Epub 2023 Sep 29.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EVOLKIN
Identifier Type: -
Identifier Source: org_study_id