Type 2 Diabetes MellitusPhase 4NCT02948777
Effects of PCSK9 Inhibition by Evolocumab on Postprandial Lipid Metabolism in Type 2 Diabetes
A Phase 4 study testing Evolocumab in people with Type 2 Diabetes Mellitus, run by Marja-Riitta Taskinen at 1 site in Finland.
Trial summary
Postprandial lipemia is highly prevalent in type 2 diabetes subjects even with normal fasting triglyceride values. Humans are mostly in a postprandial rather than in a fasting state and therefore non-fasting triglyceride values reflect more accurately the continuous exposure of arterial wall to the substantial… Read more about this study
- Who is it for?
- Ages 18 to 77 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2016to Jun 2018
- Phase
- Phase 4
- 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 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (non-fertile or using a medically approved birth control method) overweight/obese subjects with Type 2 Diabetes Mellitus treated with lifestyle counselling and a stable metformin dose for at least three months
- 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%.
- Each patient will attend a pre-screening visit (at week -5) where eligibility criteria will be evaluated. If the patient uses another statin than atorvastatin (20 mg) at screening visit the used statin is stopped and atorvastatin 20 mg will be initiated. If the patient is not using any statin, atorvastatin 20 mg will be initiated and the lipid values will be checked after 4 weeks when all inclusion/exclusion criteria will be assessed.
Who cannot join
- Type 1 diabetes
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Postprandial lipemia is highly prevalent in type 2 diabetes subjects even with normal fasting triglyceride values. Humans are mostly in a postprandial rather than in a fasting state and therefore non-fasting triglyceride values reflect more accurately the continuous exposure of arterial wall to the substantial cholesterol load from remnant particles. Evolocumab lowers blood LDL-cholesterol. This study evaluates the effect of evolocumab on postprandial lipid metabolism in type 2 diabetes. All participants in this study receive evolocumab treatment.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Evolocumab
- Keywords
- apolipoprotein, CVD, chylomicrons, evolocumab, kinetics
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Also called Repatha
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab | Experimental | Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks Receives: Drug: Evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean ApoB Concentration Before and After Evolocumab
Change in apolipoprotein B concentration in total plasma measured by using turbidimetric immunoassay.
Measured: Baseline and after 12 weeks
Mean TRL-C Concentration Before and After Evolocumab
Change in TRL-cholesterol concentration in plasma samples measured by using automated direct assay (Denka Seiken, Tokyo, Japan)
Measured: Baseline and after 12 weeks
Mean Total Production of ApoB48 Before and After Evolocumab
Change in ApoB48 total production in plasma measured by using multicompartmental modeling. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (J Clin Invest 1979;63:1262-1273) and have been widely used over 30yrs. So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. JIM 2019;285:562-577). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. These figures per day are used to report the data from this study.
Measured: Baseline and after 12 weeks
Mean LDL FCR of ApoB100 Before and After Evolocumab
Change in low-density lipoprotein fractional catabolic rate of ApoB100 in LDL from plasma samples measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
Measured: Baseline and after 12 weeks
LDL Pool Size of ApoB100 Before and After Evolocumab
Change in low-density lipoprotein pool size of ApoB100 in LDL fraction prepared from plasma samples using density ultracentrifugation.
Measured: Baseline and after 12 weeks
Secondary outcomes (20)
Mean LDL-C Concentration Before and After Evolocumab
Change in LDL-cholesterol concentration in plasma LDL fraction isolated by ultracentrifugation.
Measured: Baseline and after 12 weeks
Mean ApoB48 Concentration Before and After Evolocumab
Change in apolipoprotein B48 levels in total plasma measured by enzyme-linked immunosorbent assay.
Measured: Baseline and after 12 weeks
Mean CM TG-iAUC Before and After Evolocumab
Change in chylomicron triglyceride incremental area under curve in plasma samples taken at particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule.
Measured: 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks
Mean ApoB48 AUC Before and After Evolocumab
Change in apolipoprotein B48 area under curve in plasma samples taken at particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule.
Measured: 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks
Mean VLDL1 ApoB100 Production Before and After Evolocumab
Change in VLDL1 ApoB100 production rates measured from isolated VLDL from plasma samples using density ultracentrifugation and the enrichment of tracer was measured in isolated fractions following using mathematical modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
Measured: Baseline and after 12 weeks
Mean VLDL2 ApoB100 Production Before and After Evolocumab
Change in VLDL2 apoB100 production rates measured from isolated VLDL2 from plasma samples by using density ultracentrifugation and the enrichment of tracer was measured in isolated fractions following using mathematical modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
Measured: Baseline and after 12 weeks
IDL Pool Size of ApoB100 Before and After Evolocumab
Change in intermediate-density lipoprotein pool size of ApoB100 in IDL fraction prepared from plasma samples using density ultracentrifugation.
Measured: Baseline and after 12 weeks
Mean IDL to LDL Transfer of ApoB100 Before and After Evolocumab
Change in ApoB100 intermediate-density lipoprotein to low-density lipoprotein transfer in isolated samples from plasma by ultracentrifugation and measured using multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
Measured: Baseline and after 12 weeks
Mean VAT Before and After Evolocumab
Change in visceral fat volume measured by magnetic resonance imaging
Measured: Baseline and after 12 weeks
Mean Liver Fat Before and After Evolocumab
Change in liver fat content measured by magnetic resonance imaging.
Measured: Baseline and after 12 weeks
Mean SAT Before and After Evolocumab
Change in subcutaneous fat volume measured by magnetic resonance imaging
Measured: Baseline and after 12 weeks
Mean VLDL1 Triglyceride Production Before and After Evolocumab
Change in VLDL1 triglyceride production measured from isolated VLDL1 from plasma samples by using density gradient ultracentrifugation. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
Measured: Baseline and after 12 weeks
Mean VLDL1 FCR of triglycerideBefore and After Evolocumab
Change in VLDL1 fractional catabolic rate of triglyceride measured in isolated VLDL1 from plasma samples by using density ultracentrifugation and measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
Measured: Baseline and after 12 weeks
Mean VLDL2 Triglyceride Total Production Before and After Evolocumab
Change in VLDL2 triglyceride total production measured in isolated VLDL2 from plasma samples by using density ultracentrifugation and measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
Measured: Baseline and after 12 weeks
Mean VLDL2 FCR of Triglyceride Before and After Evolocumab
Change in VLDL2 fractional catabolic rate of triglyceride measured in isolated VLDL2 from plasma samples by using density ultracentrifugation and measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
Measured: Baseline and after 12 weeks
Mean Postprandial CM of ApoB48 Before and After Evolocumab
Change in Postprandial chylomicron of ApoB48 measured from plasma samples by liquid chromatography-mass spectrometry with multicompartmental modeling assay. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
Measured: Baseline and after 12 weeks
Mean CM-apoB48 FCR of ApoB48 Metabolism Before and After Evolocumab
Change in chylomicron-apoB48 fractional catabolic rate of ApoB48 in isolated chylomicrons from plasma samples measured by multicompartmental modeling assay. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
Measured: Baseline and after 12 weeks
Mean CM-TG Production of ApoB48 Before and After Evolocumab
Change in chylomicron-triglycerides production of ApoB48 in isolated chylomicrons from plasma samples measured by multicompartmental modeling assay. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
Measured: Baseline and after 12 weeks
Mean CM TG-AUC Before and After Evolocumab
Change in chylomicron triglyceride area under curve in plasma at a particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule.
Measured: 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks
Mean ApoB48 iAUC Before and After Evolocumab
Change in apolipoprotein B48 incremental area under curve in plasma at a particular time points after the meal. Area under the curve (AUC) was normalized so that 100% corresponds to the AUC before treatment; subsequently the percentage after treatment is in reference to this value. AUC values were calculated using the trapezoidal rule.
Measured: 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2018
- Study completionJun 2018
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 (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marja-Riitta Taskinen
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Sponsor-investigator, Marja-Riitta Taskinen, Clinical Research Institute HUCH Ltd
- Investigators
- Marja-Riitta Taskinen, Prof., PI, Principal investigator, Clinical Research institute Huch, Ltd and University of HelsinkiJan Boren, Prof., co-PI, Principal investigator, University of Gothenburg and Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948777
- Sponsor's protocol ID
- EVOLKIN
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2016
- Last updated
- 3 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33356392Taskinen 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.
PubMed 31917184Zech 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.
PubMed 221537Bjornson 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.
PubMed 30779243Taskinen 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.
PubMed 37775612
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PCSK9 Inhibition by Evolocumab on Postprandial Lipid Metabolism in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02948777
- Acronym / sponsor ID
- EVOLKIN
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- apolipoprotein, CVD, chylomicrons, evolocumab, kinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Marja-Riitta TaskinenUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- Oct 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Posted 11 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postprandial lipemia is highly prevalent in type 2 diabetes subjects even with normal fasting triglyceride values. Humans are mostly in a postprandial rather than in a fasting state and therefore non-fasting triglyceride values reflect more accurately the continuous exposure of arterial wall to the substantial cholesterol load from remnant particles. Evolocumab lowers blood LDL-cholesterol. This study evaluates the effect of evolocumab on postprandial lipid metabolism in type 2 diabetes. All participants in this study receive evolocumab treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evolocumab | Experimental | Drug: EvolocumabEvolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female (non-fertile or using a medically approved birth control method) overweight/obese subjects with Type 2 Diabetes Mellitus treated with lifestyle counselling and a stable metformin dose for at least three months
- 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%.
Key exclusion criteria (29 listed)
- Type 1 diabetes
- 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
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: Repatha | Drug | Evolocumab |
Primary outcome
Mean ApoB Concentration Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Change in apolipoprotein B concentration in total plasma measured by using turbidimetric immunoassay.
Mean TRL-C Concentration Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Change in TRL-cholesterol concentration in plasma samples measured by using automated direct assay (Denka Seiken, Tokyo, Japan)
Mean Total Production of ApoB48 Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Change in ApoB48 total production in plasma measured by using multicompartmental modeling. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (J Clin Invest 1979;63:1262-1273) and have been widely used over 30yrs. So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. JIM 2019;285:562-577). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. These figures per day are used to report the data from this study.
Mean LDL FCR of ApoB100 Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Change in low-density lipoprotein fractional catabolic rate of ApoB100 in LDL from plasma samples measured by multicompartmental modeling. Production rates were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90, 120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. More detailed description see Outcome measure 3.
LDL Pool Size of ApoB100 Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Change in low-density lipoprotein pool size of ApoB100 in LDL fraction prepared from plasma samples using density ultracentrifugation.
20 secondary outcomes
Mean LDL-C Concentration Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean ApoB48 Concentration Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean CM TG-iAUC Before and After Evolocumab
Time frame: 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks
Mean ApoB48 AUC Before and After Evolocumab
Time frame: 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks
Mean VLDL1 ApoB100 Production Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean VLDL2 ApoB100 Production Before and After Evolocumab
Time frame: Baseline and after 12 weeks
IDL Pool Size of ApoB100 Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean IDL to LDL Transfer of ApoB100 Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean VAT Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean Liver Fat Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean SAT Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean VLDL1 Triglyceride Production Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean VLDL1 FCR of triglycerideBefore and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean VLDL2 Triglyceride Total Production Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean VLDL2 FCR of Triglyceride Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean Postprandial CM of ApoB48 Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean CM-apoB48 FCR of ApoB48 Metabolism Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean CM-TG Production of ApoB48 Before and After Evolocumab
Time frame: Baseline and after 12 weeks
Mean CM TG-AUC Before and After Evolocumab
Time frame: 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks
Mean ApoB48 iAUC Before and After Evolocumab
Time frame: 0, 2, 4, 6, 8 hours after the meal at baseline and after 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33356392Taskinen 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.
- Results publication: PubMed 31917184Taskinen 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.
- Results publication: PubMed 221537Zech 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.
- Results publication: PubMed 30779243Bjornson 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.
- Derived from this study: PubMed 37775612Taskinen 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.
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Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Marja-Riitta Taskinen, Prof., PI principal investigator
Clinical Research institute Huch, Ltd and University of Helsinki
Jan Boren, Prof., co-PI principal investigator
University of Gothenburg and Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evolocumab in people with Type 2 Diabetes Mellitus, run by Marja-Riitta Taskinen at 1 site in Finland.
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 6 inclusion and 29 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Oct 2021). 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?
Mean ApoB Concentration Before and After Evolocumab (time frame: Baseline and after 12 weeks). The study lists 5 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 NCT02948777, which also lists 5 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 3 Nov 2021.