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    The EU Clinical Trials Register currently displays   38191   clinical trials with a EudraCT protocol, of which   6274   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-004434-41
    Sponsor's Protocol Code Number:70917
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-12
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-004434-41
    A.3Full title of the trial
    Fenofibrate as an Early Treatment Option in Type 1 Diabetes: A randomized, double-blind, placebo-controlled, trial to evaluate antidiabetic effects of Fenofibrate in patient with newly onset type 1 diabetes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fenofibrate as an Early Treatment Option in Type 1 Diabetes: A clinical trial to evaluate antidiabetic effects of Fenofibrate in patient with newly onset type 1 diabetes.
    A.4.1Sponsor's protocol code number70917
    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 SponsorFlemming Pociot
    B.1.3.4CountryDenmark
    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 supportSteno Diabetes Center Copenhagen
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFlemming Pociot
    B.5.2Functional name of contact pointFlemming Pociot
    B.5.3 Address:
    B.5.3.1Street AddressNiels Steensens Vej 2, NSE
    B.5.3.2Town/ cityGentofte
    B.5.3.3Post code2820
    B.5.3.4CountryDenmark
    B.5.6E-mailflemming.pociot@regionh.dk
    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 Fenofibrat Heumann 160 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderHEUMANN PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFenofibrate
    D.3.9.1CAS number 49562-28-9
    D.3.9.3Other descriptive nameFENOFIBRATE (NANONISED)
    D.3.9.4EV Substance CodeSUB166158
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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) No
    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 placeboFilm-coated tablet
    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
    Newly onset Type 1 Diabetes, with first insulin injection maximum six weeks prior inclusion in this trial
    E.1.1.1Medical condition in easily understood language
    Patients with newly diagnosed Type 1 Diabetes
    Patienter med nyopdaget type 1 sukkersyge
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate if chronic treatment with Fenofibrate in therapeutic doses will stop disease progression and improve residual insulin production in patient with newly onset T1D.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Diagnosed T1D (E10.9) and aged 16 to 46 years old at inclusion.
    2.First injection of insulin maximum six weeks prior to inclusion.
    3.Must be willing and capable of taking the study drugs and meet for tests as described in the protocol.
    4.Signed informed consent and expected cooperation of the patient for the treatment and follow up must be obtained and documented according to the guidelines for good clinical practice (GCP) and Danish regulations.

    E.4Principal exclusion criteria
    1.Treatment with any oral or injected anti-diabetic medications other than insulin.
    2.A medical history of liver disease, pancreatitis, kidney disease, myositis, or venous thromboembolic events
    3.Participation in interventional or other drug research studies which could affect the objectives of this study.
    4.Inability or unwillingness to comply with the provisions of this protocol.
    5.Females who are lactating, pregnant or planning to become pregnant within 12 months after inclusion. Males or fertile women not willing to use adequate contraception, if sexually active
    6.Presence of serious disease or condition, which in the opinion of the Investigator makes the patient non-eligible for the study.
    7.C-peptide levels < 0.2 nmol/L upon inclusion measured during a mixed meal tolerance test (MMTT)
    8.Absence of islet autoantibody (Glutamic acid decarboxylase-65 antibodies (GAD65), Insulin antibodies (IAA), Islet antigen-2 antibodies (IA-2) or Zinc Transporter 8 antibodies (ZnT8))
    E.5 End points
    E.5.1Primary end point(s)
    Change in mean residual insulin secretion measured by C-peptide area under the curve after a 2 hours Mixed Meal Tolerance Test, 12 months after initiation of trial treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after inclusion
    E.5.2Secondary end point(s)
    1. Change in mean residual insulin secretion measured by stimulated C-peptide after 1, 3, and 6 months of treatment and 12 months after end of treatment (24 months after inclusion).
    2. Proportion of patients with peak stimulated C-peptide > 0.2 nmol/L
    4. Changes in mean insulin dosage in units per kilo bodyweight for 24 hours one week before each trial visit.
    5. HbA1c at every trial visit. Both the absolute level and the change from visit 1 will be analysed.
    6. Number of hypoglycaemic events since last visit, and the total number of events after 12 months of treatment with trial medication.
    7. Changes in Model-estimated beta cell function
    8. Proinsulin/c-peptide ratio in serum as a measure of beta-cell stress
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3, 6,12 and 24 months after inclusion
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 48
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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 Information not present in EudraCT
    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 state58
    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. Thus patients are recommended to continue standard treatment for T1D, provided by their own physician in alignment with national and local guidelines during this trial as well as post trial.
    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 Decision2020-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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