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    Summary
    EudraCT Number:2020-004966-20
    Sponsor's Protocol Code Number:Image-Ver-A-T1D
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-004966-20
    A.3Full title of the trial
    A GLP-1 receptor PET imaging substudy within the VER-AT1D trial investigating the effects on beta cell mass.
    Etude de l’imagerie TEP du récepteur GLP-1, compagnon de l’étude Ver-A-T1D évaluant les effets d’une thérapie sur la masse des cellules bêta pancréatiques.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PET imaging substudy within the VER-AT1D trial investigating the effects on beta cell mass
    Etude complémentaire d'imagerie dans le cadre de l'essai Ver-A-T1D visant à étudier les effets sur la masse des cellules bêta
    A.3.2Name or abbreviated title of the trial where available
    PET imaging of beta cells in Type 1 diabetes, effect of verapamil (Image-Ver-A-T1D)
    Imagerie TEP des cellules bêta dans le diabête de Type 1 , effet du vérapamil (Image-Ver-A-T1D)
    A.4.1Sponsor's protocol code numberImage-Ver-A-T1D
    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 SponsorRadboud University Medical Center
    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 supportRadboud University Medical Center
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportEuropean Union (Horizon 2020)
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique Hôpitaux de Paris (APHP)
    B.5.2Functional name of contact pointPr. J-N Talbot /Scientific adviser
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Tenon, Bâtiment de Rercherches, 4 Rue de Chine
    B.5.3.2Town/ cityParis Cédex 20
    B.5.3.3Post code75970
    B.5.3.4CountryFrance
    B.5.4Telephone number01 56 01 79 94
    B.5.6E-mailjean-noel.talbot@aphp.fr
    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 No
    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.3.1Product name68GA-EXENDIN-NODAGA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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) 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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 diabetes mellitus
    Diabète sucré de type 1
    E.1.1.1Medical condition in easily understood language
    Type 1 Insulin-dependent diabetes
    Diabète insulinodépendant de type 1
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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 measure pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for detection of intra-individual differences in beta cell mass before and after treatment and inter-individual differences between the treatment group and the placebo group.
    Mesurer en TEP/TDM la fixation de 68Ga-NODAGA-exendine-4 par les cellules bêta pancréatiques à la recherche de différences intra-individuelles de la masse des cellules bêta avant et après le traitement et de différences interindividuelles entre le groupe avec traitement actif et le groupe placebo
    E.2.2Secondary objectives of the trial
    To compare changes in pancreatic 68Ga-NODAGA-exendin uptake to changes in C-peptide and proinsulin/preproinsulin measurements.

    To quantify the differences in 68Ga-NODAGA-exendin uptake between individuals and between the two time points of imaging intra-individually for future calculations of study group sizes.
    Comparer les changements dans la fixation pancréatique de 68Ga-NODAGA-exendine-4 aux changements de concentration sérique du peptide C et de la proinsuline / préproinsuline.

    Quantifier les différences de fixation de 68Ga-NODAGA-exendine-4 entre les individus et entre l'imagerie avant et après le traitement pour chaque individu. Ces données seront utiles pour les calculs de la taille des groupes lors de futures études.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient:
    Are included in the Ver-A-T1D trial, but have not started treatment/placebo.
    Have given written informed consent.
    Age ≥18 years at consent
    Patient :
    Inclus dans l'essai Ver-A-T1D, mais n'a pas commencé de traitement / placebo
    A donné son consentement éclairé par écrit
    Âge ≥ 18 ans au moment du consentement
    E.4Principal exclusion criteria
    (additional to Ver-A-T1D):
    -Treatment with synthetic exendin (Exentide, Byetta®) or dipeptidyl-peptidase IV inhibitors (to exclude interferences with imaging), specifically mentioned although in principle part of exclusion criteria Ver-A-T1D.
    - Renal disease defined as MDRD < 40 ml/min/1.73m2
    - Pregnancy or the wish to become pregnant within 2 month after the second PET/CT scan.
    Critères d'exclusion (en plus de ceux de l’étude Ver-A-T1D) :

    - Traitement par inhibiteurs de l'exendine synthétique (Exentide, Byetta®) ou de la dipeptidyl-peptidase IV (pour exclure les interférences avec l'imagerie), bien qu'en principe ce soit aussi des critères d'exclusion pour l’étude Ver-A-T1D.
    - Maladie rénale définie par une clairance glomérulaire <40 mL / min / 1,73 m2 selon la formule MDRD
    - Grossesse ou souhait de grossesse dans les deux mois suivant la deuxième TEP / TDM.
    E.5 End points
    E.5.1Primary end point(s)
    Measure the total pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for determination of beta cell mass at the point of inclusion and after 12 months.
    Mesurer la fixation pancréatique totale de 68Ga-NODAGA-exendine-4 pour la détermination de la masse cellulaire bêta à l'inclusion et après 12 mois
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessment before inclusion in the Ver-A-T1D study and at the end of the study after 12 months of treatment.
    Évaluation avant l'inclusion dans l'étude Ver-A-T1D et après 12 mois de traitement.
    E.5.2Secondary end point(s)
    - Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in C-peptide measurements
    - Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in proinsulin/preproinsulin measurements.
    - Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two time points of imaging intra-individually
    - Modifications de la fixation du 68Ga-NODAGA-exendine-4 par le pancréas en relation avec les modifications de la concentration sérique du peptide C
    - Modifications de la fixation de 68Ga-NODAGA-exendine-4 dans le pancréas en relation avec les modifications de la concentration sérique de la proinsuline / préproinsuline.
    - Différences de fixation de 68Ga-NODAGA-exendine-4 entre les individus et entre les deux moments d’acquisition des images
    .
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessment before inclusion in the Ver-A-T1D study and at the end of the study after 12 months of treatment.
    Évaluation avant l'inclusion dans l'étude Ver-A-T1D et après 12 mois de traitement.
    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 Yes
    E.6.5Efficacy Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    United Kingdom
    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
    La dernière visite du dernier patient
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 30
    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 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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    No post treatment planned except normal standard of care.
    Traitement standard
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation INNODIA
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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