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    Summary
    EudraCT Number:2018-001663-22
    Sponsor's Protocol Code Number:na
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-001663-22
    A.3Full title of the trial
    Effects of ciprofibrate on myocardial insulin sensitivity in pre-diabetes
    Effect van ciprofibraat op insuline gevoeligheid van het hart in pre-diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ciprofibrate and pre-diabetes
    Ciprofibraat en pre-diabetes
    A.3.2Name or abbreviated title of the trial where available
    Ciprofibrate and pre-diabetes
    Ciprofibraat en pre-diabetes
    A.4.1Sponsor's protocol code numberna
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMaastricht University
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNUTRIM
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University
    B.5.2Functional name of contact pointNUTRIM
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitssingel 50
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 ER
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031433881476
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ciprofibrate
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis Netherlands B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Insulin resistance, diastolic cardiac failure, mitochondrial function
    Insuline resistentie, diastolisch hartfalen, mitochondriele functie
    E.1.1.1Medical condition in easily understood language
    Pre-diabetes and cardiac failure
    Pre-diabetes en hartfalen
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine whether ciprofibrate treatment can improve myocardial insulin sensitivity in subjects with IGM (impaired glucose metabolism).
    Onderzoeken of ciprofibraat administratie myocardiale insuline sensitiviteit kan vergroten in personen met IGM.
    E.2.2Secondary objectives of the trial
    To examine whether ciprofibrate treatment in IGM:
    • Improves in vivo myocardial mitochondrial function
    • Lowers intracardiomyocellular lipid content
    • Improves cardiac diastolic function
    • Augments hepatic and skeletal muscle glucose uptake
    • Improves intrahepatic lipid content and composition
    • Stimulates the PPARĪ± expression and their down-stream targets in humans (measured in skeletal muscle biopsies)
    Onderzoeken of ciprofibraat behandeling in IGM kan:
    - verbeteren in vivo myocardiale mitochondriele functie
    - verlagen van intracardiomyocellulaire accumulatie
    - verbeteren van cardiale diastole functie
    - vergroten glucose opname door lever en skeletspier
    - verlagen intrahepatische vetopslag en veranderen vetcompositie in lever
    - stimuleren PPARa expressie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Sex: male
    • Age: 40-70 years
    • BMI: 27-35 kg/m2
    • Stable dietary habits: no weight gain or loss > 5kg in the last three months
    • Insulin resistant: glucose clearance rate below < 360 ml/kg/min, as determined using OGIS120
    • Geslacht: man
    • Leeftijd: 40-70 jaar
    • BMI: 27-35 kg/m2
    • Stabiel gewicht: geen gewichts toename/verlies >5kg in afgelopen 3 maanden
    • Insuline resistent: glucose klaringsratio < 360 ml/kg/min, zoals bepaald volgens OGIS120
    E.4Principal exclusion criteria
    • Patients with a cardiac disease or with instable angina
    • Haemoglobin <7.8 mmol/l
    • In case of an abnormal ECG in rest: this will be discussed with the responsible medical doctor
    • HbA1c > 6.5%
    • Diagnosed with type 1 or type 2 diabetes mellitus
    • Use of a fibrate
    • Medication use known to interfere with glucose homeostasis/metabolism
    • Use of anti-coagulants, excluding platelet aggregation inhibitors
    • Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study.
    • Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.
    • Participation in another biomedical study within 1 month before the first screening visit
    • Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk
    • Any contra-indication to MRI scanning.
    • Participation in earlier research or medical examinations in the past 3 months that included PET/MRI scanning
    • Patienten met cardiale ziekten of instabiele angina pectoris
    • Hemoglobine <7.8 mmol/l
    • Bij abnormaal rust-ECG: dit wordt besproken met verantwoordelijk afhankelijk arts
    • HbA1c > 6.5%
    • Gediagnosticeerd met type 1 of 2 diabetes mellitus
    • Gebruik van een fibraat
    • Medicatie dat interfereert met glucose homeostase / metabolisme
    • Gebruik van anti-coagulantia, behoudens trombocyten aggregatie remmers
    • Personen die niet geinformeerd willen worden over onverwachte medische bevindingen uit de screening of studie; of zij die niet willen dat hun huisarts wordt geinformeerd.
    • Personen die bloed willen doneren gedurende de interventie of personen <3 maanden voor aanvang van de interventie bloed hebben gedoneerd
    • Deelname in een andere biomedische studie <1 maand voor de eerste screenings visite.
    • Elke omstandigheid, ziekte of abnormaal laboratorium resultaat, die volgens de onderzoeker kan interfereren met de studie uitkomsten of studie deelname beinvloedt of persoon in gevaar kan brengen.
    • Contra-indicatie voor MRI scanning.
    • PET scan in afgelopen 3 maanden (in het kader van onderzoek of medisch onderzoek).
    E.5 End points
    E.5.1Primary end point(s)
    Myocardial glucose uptake
    Myocardiale glucose opname
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 35 days supplementation ciprofibrate
    Na 35 dagen toediening ciprofibrate
    E.5.2Secondary end point(s)
    Insulin sensitivity in clamp procedure
    Insuline gevoeligheid gedurende clamp
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 35 days supplementation ciprofibrate
    Na 35 dagen toediening ciprofibrate
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Geen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-06
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