Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Effects of PCSK9 inhibition by Evolocumab on postprandial lipid metabolism in type 2 diabetes

    Summary
    EudraCT number
    		 2016-001176-30
    Trial protocol
    		 FI  
    Global end of trial date
    23 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2021
    First version publication date
    27 Mar 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    20167169
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02948777
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clinical Research Institute, HUCH Ltd.
    Sponsor organisation address
    Haartmaninkatu 8, Helsinki, Finland,
    Public contact
    Research Program Unit, University of Helsinki, Research Program Unit, University of Helsinki, +358 947171990, marja-riitta.taskinen@helsinki.fi
    Scientific contact
    Research Program Unit, University of Helsinki, Research Program Unit, University of Helsinki, +358 947171990, marja-riitta.taskinen@helsinki.fi
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    24 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    23 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The overall aim is to clarify the postprandial dynamics of PCSK9 on the pathophysiology of postprandial hypertriglyceridemia in people with type 2 diabetes. The effect of 12 weeks treatment with Evolocumab 140 mg s.c. Q2W on postprandial lipid and lipoprotein metabolism will be assessed in patients with type 2 diabetes (n=12) in an one-arm unblinded clinical trial.
    Protection of trial subjects
    Evolocumab is a prescription medicine and the subjects having analyses have minimal pain and no distress, so no protection was needed.
    Background therapy
    		 Statin
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    7
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were recruited from previous studies and by using two advertisement in the biggest daily newspaper in Finland, Helsingin Sanomat on 2nd October 2016 and 26th March 2019.

    Pre-assignment
    Screening details
    		 Screening period: Telefone screening (195 subjects) and Screening visit 1 (77 subjects). Run-in period: Screening visit 2 including physician visit and atorvastatin + metformin start (37 subjects) and Screening visit 3 including lipid values check (22 subjects). Inclusion and exclusion criteria are listed in protocol.

    Period 1
    Period 1 title
    Baseline run-in period 2-4 weeks
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Analyses
    Arm description
    		 Lipoprotein kinetic analyses using stable isotopes in the postprandial state. A measurements of liver fat content in the fasting state by MRI was performed within 7 days before the start of the kinetic procedure.
    Arm type
    		 Experimental

    Investigational medicinal product name
    atorvastatin is initiated if other statin is used
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The subjects will use metformin at a stable dose (500-3000 mg per day) throughout the study. If the patient uses another statin than atorvastatin (20 mg) at screening visit the used statin is stopped and atorvastatin 20 mg is 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. If eligible (LDL>1.8 mmol/L), the patient can be recruited. The subjects will continue using atorvastatin 20 mg throughout the study. However, patients using atorvastatin 40 mg / day will continue on atorvastatin 40 mg / day (it is not ethical to reduce the dose if LDL-C is >1.8 mmol/L). The subjects will use the metformin as a prescription medication. Atorvastatin will be administered by the study centre to the subjects.

    Number of subjects in period 1
    		Analyses
    Started
    14
    Completed
    14
    Period 2
    Period 2 title
    Treatment period evolocumab
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Kinetic visit 1
    Arm description
    		 Injections of stable isotopes and blood sampling for kinetic procedure and standard oral fat tolerance test, MRI and heparin tests on separate dates.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Evolocumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Evolocumab (AMG 145) is supplied as a sterile, single-use, preservative free solution for subcutaneous injection in a disposable, spring-based prefilled autoinjector (AI)/pen. The AI/pen contains a 1.0 mL deliverable volume of 140 mg/mL Evolocumab in 220 mM proline, 20 mM acetate, 0.01% (w/v) polysorbate 80, pH 5.0. Evolocumab will be administered 140 mg s.c. Q2W without any dose adjustments or escalation.

    Arm title
    		 Week 2
    Arm description
    		 Study visit with safety monitoring.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Evolocumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Evolocumab (AMG 145) is supplied as a sterile, single-use, preservative free solution for subcutaneous injection in a disposable, spring-based prefilled autoinjector (AI)/pen. The AI/pen contains a 1.0 mL deliverable volume of 140 mg/mL Evolocumab in 220 mM proline, 20 mM acetate, 0.01% (w/v) polysorbate 80, pH 5.0. Evolocumab will be administered 140 mg s.c. Q2W without any dose adjustments or escalation.

    Arm title
    		 Week 4
    Arm description
    		 Study visit with safety monitoring.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Evolocumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Evolocumab (AMG 145) is supplied as a sterile, single-use, preservative free solution for subcutaneous injection in a disposable, spring-based prefilled autoinjector (AI)/pen. The AI/pen contains a 1.0 mL deliverable volume of 140 mg/mL Evolocumab in 220 mM proline, 20 mM acetate, 0.01% (w/v) polysorbate 80, pH 5.0. Evolocumab will be administered 140 mg s.c. Q2W without any dose adjustments or escalation.

    Arm title
    		 Week 8
    Arm description
    		 Study visit with safety monitoring.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Evolocumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Evolocumab (AMG 145) is supplied as a sterile, single-use, preservative free solution for subcutaneous injection in a disposable, spring-based prefilled autoinjector (AI)/pen. The AI/pen contains a 1.0 mL deliverable volume of 140 mg/mL Evolocumab in 220 mM proline, 20 mM acetate, 0.01% (w/v) polysorbate 80, pH 5.0. Evolocumab will be administered 140 mg s.c. Q2W without any dose adjustments or escalation.

    Arm title
    		 Kinetic visit 2
    Arm description
    		 Injections of stable isotopes and blood sampling for kinetic procedure and a standard oral fat tolerance test repeated.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Evolocumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Evolocumab (AMG 145) is supplied as a sterile, single-use, preservative free solution for subcutaneous injection in a disposable, spring-based prefilled autoinjector (AI)/pen. The AI/pen contains a 1.0 mL deliverable volume of 140 mg/mL Evolocumab in 220 mM proline, 20 mM acetate, 0.01% (w/v) polysorbate 80, pH 5.0. Evolocumab will be administered 140 mg s.c. Q2W without any dose adjustments or escalation.

    Number of subjects in period 2
    		Kinetic visit 1 Week 2 Week 4 Week 8 Kinetic visit 2
    Started
    14
    14
    14
    14
    14
    Completed
    14
    14
    14
    14
    14

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Baseline run-in period 2-4 weeks
    Reporting group description
    		 -

    Reporting group values
    		 Baseline run-in period 2-4 weeks Total
    Number of subjects
    		 14 14
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 7 7
        From 65-84 years
    		 7 7
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 6 6
    BMI
    Units: BMI
        arithmetic mean (full range (min-max))
    		 30 (25 to 40) -
    Triglycerides
    Units: mmol/l
        arithmetic mean (full range (min-max))
    		 1.6 (1.0 to 4.5) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Analyses
    Reporting group description
    		 Lipoprotein kinetic analyses using stable isotopes in the postprandial state. A measurements of liver fat content in the fasting state by MRI was performed within 7 days before the start of the kinetic procedure.
    Reporting group title
    Kinetic visit 1
    Reporting group description
    		 Injections of stable isotopes and blood sampling for kinetic procedure and standard oral fat tolerance test, MRI and heparin tests on separate dates.

    Reporting group title
    Week 2
    Reporting group description
    		 Study visit with safety monitoring.

    Reporting group title
    Week 4
    Reporting group description
    		 Study visit with safety monitoring.

    Reporting group title
    Week 8
    Reporting group description
    		 Study visit with safety monitoring.

    Reporting group title
    Kinetic visit 2
    Reporting group description
    		 Injections of stable isotopes and blood sampling for kinetic procedure and a standard oral fat tolerance test repeated.

    Primary: TRL-C kinetic study

    		 Close Top of page
    End point title
    		 TRL-C kinetic study
    End point description
    More end point parameters found in published paper by Taskinen MR, Björnson E, Kahri J, Söderlund 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, Borén 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. 2020 Dec 24:ATVBAHA120315446.
    End point type
    Primary
    End point timeframe
    Difference in the parameter between kinetic visit 1 and kinetic visit 2.
    End point values
    		 Kinetic visit 1 Kinetic visit 2
    Number of subjects analysed
    14
    14
    Units: mg/dL
        arithmetic mean (standard deviation)
    33.4 ± 10.9
    17.8 ± 6.5
    Attachments
    		 Untitled (Filename: Table 1. Taskinen MR et al. ATVB. 2020, ATVBAHA120315446..pdf)
    Statistical analysis title
    		 TRL-C
    Comparison groups
    Kinetic visit 1 v Kinetic visit 2
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - The trial was a single-phase, nonrandomized study of 12-week treatment with evolocumab 140 mg subcutaneously every 2 weeks in 14 patients with type II diabetes on background statin therapy. Cardiometabolic responses to a high-fat mixed meal were assessed before and at the end of the intervention period.

    Primary: VLDL2 pool

    		 Close Top of page
    End point title
    		 VLDL2 pool
    End point description
    More end point parameters found in published paper by Taskinen MR, Björnson E, Kahri J, Söderlund 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, Borén 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. 2020 Dec 24:ATVBAHA120315446.
    End point type
    Primary
    End point timeframe
    Difference in the parameter between kinetic visit 1 and kinetic visit 2.
    End point values
    		 Kinetic visit 1 Kinetic visit 2
    Number of subjects analysed
    14
    14
    Units: mg
        arithmetic mean (standard deviation)
    130 ± 47
    93 ± 58
    Attachments
    		 Untitled (Filename: Table 2. Taskinen MR et al. ATVB. 2020, ATVBAHA120315446..pdf)
    Statistical analysis title
    		 VLDL2 pool
    Comparison groups
    Kinetic visit 1 v Kinetic visit 2
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [2] - The trial was a single-phase, nonrandomized study of 12-week treatment with evolocumab 140 mg subcutaneously every 2 weeks in 14 patients with type II diabetes on background statin therapy. Cardiometabolic responses to a high-fat mixed meal were assessed before and at the end of the intervention period.

    Primary: ApoC-III

    		 Close Top of page
    End point title
    		 ApoC-III
    End point description
    More end point parameters found in published paper by Taskinen MR, Björnson E, Kahri J, Söderlund 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, Borén 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. 2020 Dec 24:ATVBAHA120315446.
    End point type
    Primary
    End point timeframe
    Difference in the parameter between kinetic visit 1 and kinetic visit 2.
    End point values
    		 Kinetic visit 1 Kinetic visit 2
    Number of subjects analysed
    14
    14
    Units: mg/dL
        arithmetic mean (standard deviation)
    12.2 ± 4.3
    10.4 ± 5.2
    Attachments
    		 Untitled (Filename: Table 1. Taskinen MR et al. ATVB. 2020, ATVBAHA120315446..pdf)
    Statistical analysis title
    		 ApoC-III
    Comparison groups
    Kinetic visit 2 v Kinetic visit 1
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - The trial was a single-phase, nonrandomized study of 12-week treatment with evolocumab 140 mg subcutaneously every 2 weeks in 14 patients with type II diabetes on background statin therapy. Cardiometabolic responses to a high-fat mixed meal were assessed before and at the end of the intervention period.

    Primary: VLDL2 FCR

    		 Close Top of page
    End point title
    		 VLDL2 FCR
    End point description
    More end point parameters found in published paper by Taskinen MR, Björnson E, Kahri J, Söderlund 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, Borén 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. 2020 Dec 24:ATVBAHA120315446.
    End point type
    Primary
    End point timeframe
    Difference in the parameter between kinetic visit 1 and kinetic visit 2.
    End point values
    		 Kinetic visit 1 Kinetic visit 2
    Number of subjects analysed
    14
    14
    Units: pools/d
        arithmetic mean (standard deviation)
    6.6 ± 3.3
    9.5 ± 4.2
    Attachments
    		 Untitled (Filename: Table 2. Taskinen MR et al. ATVB. 2020, ATVBAHA120315446..pdf)
    Statistical analysis title
    		 VLDL2 FCR
    Comparison groups
    Kinetic visit 1 v Kinetic visit 2
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [4] - The trial was a single-phase, nonrandomized study of 12-week treatment with evolocumab 140 mg subcutaneously every 2 weeks in 14 patients with type II diabetes on background statin therapy. Cardiometabolic responses to a high-fat mixed meal were assessed before and at the end of the intervention period.

    Primary: IDL pool

    		 Close Top of page
    End point title
    		 IDL pool
    End point description
    More end point parameters found in published paper by Taskinen MR, Björnson E, Kahri J, Söderlund 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, Borén 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. 2020 Dec 24:ATVBAHA120315446.
    End point type
    Primary
    End point timeframe
    Difference in the parameter between kinetic visit 1 and kinetic visit 2.
    End point values
    		 Kinetic visit 1 Kinetic visit 2
    Number of subjects analysed
    14
    14
    Units: mg
        arithmetic mean (standard deviation)
    190 ± 50
    130 ± 49
    Attachments
    		 Untitled (Filename: Table 2. Taskinen MR et al. ATVB. 2020, ATVBAHA120315446..pdf)
    Statistical analysis title
    		 IDL pool
    Comparison groups
    Kinetic visit 1 v Kinetic visit 2
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [5] - The trial was a single-phase, nonrandomized study of 12-week treatment with evolocumab 140 mg subcutaneously every 2 weeks in 14 patients with type II diabetes on background statin therapy. Cardiometabolic responses to a high-fat mixed meal were assessed before and at the end of the intervention period.

    Primary: IDL to LDL transfer

    		 Close Top of page
    End point title
    		 IDL to LDL transfer
    End point description
    More end point parameters found in published paper by Taskinen MR, Björnson E, Kahri J, Söderlund 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, Borén 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. 2020 Dec 24:ATVBAHA120315446.
    End point type
    Primary
    End point timeframe
    Difference in the parameter between kinetic visit 1 and kinetic visit 2.
    End point values
    		 Kinetic visit 1 Kinetic visit 2
    Number of subjects analysed
    14
    14
    Units: mg/d
        arithmetic mean (standard deviation)
    450 ± 190
    310 ± 140
    Attachments
    		 Untitled (Filename: Table 2. Taskinen MR et al. ATVB. 2020, ATVBAHA120315446..pdf)
    Statistical analysis title
    		 IDL to LDL transfer
    Comparison groups
    Kinetic visit 1 v Kinetic visit 2
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [6] - The trial was a single-phase, nonrandomized study of 12-week treatment with evolocumab 140 mg subcutaneously every 2 weeks in 14 patients with type II diabetes on background statin therapy. Cardiometabolic responses to a high-fat mixed meal were assessed before and at the end of the intervention period.

    Primary: VLDL2 pool

    		 Close Top of page
    End point title
    		 VLDL2 pool
    End point description
    More end point parameters found in published paper by Taskinen MR, Björnson E, Kahri J, Söderlund 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, Borén 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. 2020 Dec 24:ATVBAHA120315446.
    End point type
    Primary
    End point timeframe
    Difference in the parameter between kinetic visit 1 and kinetic visit 2.
    End point values
    		 Kinetic visit 1 Kinetic visit 2
    Number of subjects analysed
    14
    14
    Units: g
        arithmetic mean (standard deviation)
    1.1 ± 0.43
    0.75 ± 0.43
    Attachments
    		 Untitled (Filename: Table 2. Taskinen MR et al. ATVB. 2020, ATVBAHA120315446..pdf)
    Statistical analysis title
    		 VLDL2 pool
    Comparison groups
    Kinetic visit 1 v Kinetic visit 2
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [7] - The trial was a single-phase, nonrandomized study of 12-week treatment with evolocumab 140 mg subcutaneously every 2 weeks in 14 patients with type II diabetes on background statin therapy. Cardiometabolic responses to a high-fat mixed meal were assessed before and at the end of the intervention period.

    Primary: VLDL2 FCR

    		 Close Top of page
    End point title
    		 VLDL2 FCR
    End point description
    More end point parameters found in published paper by Taskinen MR, Björnson E, Kahri J, Söderlund 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, Borén 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. 2020 Dec 24:ATVBAHA120315446.
    End point type
    Primary
    End point timeframe
    Difference in the parameter between kinetic visit 1 and kinetic visit 2.
    End point values
    		 Kinetic visit 1 Kinetic visit 2
    Number of subjects analysed
    14
    14
    Units: pools/d
        arithmetic mean (standard deviation)
    10 ± 6.3
    15 ± 8.7
    Attachments
    		 Untitled (Filename: Table 2. Taskinen MR et al. ATVB. 2020, ATVBAHA120315446..pdf)
    Statistical analysis title
    		 VLDL2 FCR
    Comparison groups
    Kinetic visit 1 v Kinetic visit 2
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [8] - The trial was a single-phase, nonrandomized study of 12-week treatment with evolocumab 140 mg subcutaneously every 2 weeks in 14 patients with type II diabetes on background statin therapy. Cardiometabolic responses to a high-fat mixed meal were assessed before and at the end of the intervention period.

    Primary: CM-apoB48 FCR

    		 Close Top of page
    End point title
    		 CM-apoB48 FCR
    End point description
    More end point parameters found in published paper by Taskinen MR, Björnson E, Kahri J, Söderlund 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, Borén 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. 2020 Dec 24:ATVBAHA120315446.
    End point type
    Primary
    End point timeframe
    Difference in the parameter between kinetic visit 1 and kinetic visit 2.
    End point values
    		 Kinetic visit 1 Kinetic visit 2
    Number of subjects analysed
    14
    14
    Units: pools/d
        arithmetic mean (standard deviation)
    37 ± 24
    46 ± 32
    Attachments
    		 Untitled (Filename: Table 2. Taskinen MR et al. ATVB. 2020, ATVBAHA120315446..pdf)
    Statistical analysis title
    		 CM-apoB48 FCR
    Comparison groups
    Kinetic visit 1 v Kinetic visit 2
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [9] - The trial was a single-phase, nonrandomized study of 12-week treatment with evolocumab 140 mg subcutaneously every 2 weeks in 14 patients with type II diabetes on background statin therapy. Cardiometabolic responses to a high-fat mixed meal were assessed before and at the end of the intervention period.

    Primary: CM-TG FCR

    		 Close Top of page
    End point title
    		 CM-TG FCR
    End point description
    More end point parameters found in published paper by Taskinen MR, Björnson E, Kahri J, Söderlund 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, Borén 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. 2020 Dec 24:ATVBAHA120315446.
    End point type
    Primary
    End point timeframe
    Difference in the parameter between kinetic visit 1 and kinetic visit 2.
    End point values
    		 Kinetic visit 1 Kinetic visit 2
    Number of subjects analysed
    14
    14
    Units: pools/d
        arithmetic mean (standard deviation)
    41 ± 27
    54 ± 31
    Attachments
    		 Untitled (Filename: Table 2. Taskinen MR et al. ATVB. 2020, ATVBAHA120315446..pdf)
    Statistical analysis title
    		 CM-TG FCR
    Comparison groups
    Kinetic visit 1 v Kinetic visit 2
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [10] - The trial was a single-phase, nonrandomized study of 12-week treatment with evolocumab 140 mg subcutaneously every 2 weeks in 14 patients with type II diabetes on background statin therapy. Cardiometabolic responses to a high-fat mixed meal were assessed before and at the end of the intervention period.

    Primary: TRL-C cardiometabolic study

    		 Close Top of page
    End point title
    		 TRL-C cardiometabolic study
    End point description
    More end point parameters found in published paper by Taskinen MR, Björnson E, Andersson L, Kahri J, Porthan K, Matikainen N, Söderlund S, Pietiläinen K, Hakkarainen A, Lundbom N, Nilsson R, Ståhlman M, Adiels M, Parini P, Packard C, Borén 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.
    End point type
    Primary
    End point timeframe
    Difference in the parameter between kinetic visit 1 and kinetic visit 2.
    End point values
    		 Kinetic visit 1 Kinetic visit 2
    Number of subjects analysed
    14
    14
    Units: mg/dL
        arithmetic mean (standard deviation)
    33.4 ± 11
    17.8 ± 6.5
    Attachments
    		 Untitled (Filename: Figure 1. Taskinen MR et al. J Clin Lipidol. 2020,14, 77-87..pdf)
    Untitled (Filename: Table 1. Taskinen MR et al. J Clin Lipidol. 2020,14, 77-87..pdf)
    Statistical analysis title
    		 TRL-C
    Comparison groups
    Kinetic visit 1 v Kinetic visit 2
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Confidence interval
    Notes
    [11] - The trial was a single-phase, nonrandomized study of 12-week treatment with evolocumab 140 mg subcutaneously every 2 weeks in 14 patients with type II diabetes on background statin therapy. Cardiometabolic responses to a high-fat mixed meal were assessed before and at the end of the intervention period.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    21 November 2016-23 April 2018
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Duodecim
    Dictionary version
    2020
    Reporting groups
    Reporting group title
    Treatment period evolocumab
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment period evolocumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 14 (14.29%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Blood and lymphatic system disorders
    Increase in blood glucose
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Iron deficiency anemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Non-cardiac chest pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment period evolocumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hypertension
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Tachycardia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nervous system disorders
    Postural vertigo
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Tiredness
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Tinnitus
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Eosinophilia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Thrombocytosis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Macrocytosis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Microcytosis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gastrointestinal disorders
    Heartburn
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Respiratory infection / flu
         subjects affected / exposed
    10 / 14 (71.43%)
         occurrences all number
    10
    Exacerbation of asthma
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Skin eruption
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Edema 
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Renal and urinary disorders
    Pyuria
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Hematuria
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Infections and infestations
    Fungal nail disease
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Maxillary sinusitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Herpes simplex labialis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Worsening of diabetes
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hypokalemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33356392
    http://www.ncbi.nlm.nih.gov/pubmed/31917184
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 02:10:44 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA