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    Summary
    EudraCT Number:2017-002959-29
    Sponsor's Protocol Code Number:GLP1-honeymoon
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-13
    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 number2017-002959-29
    A.3Full title of the trial
    Comparison of the beta cell mass during and shortly after the honeymoon phase of type 1 diabetes using Ga-68-exendin PET
    Vergelijking van de bètacel-massa tijdens en kort na de honeymoonfase van type 1 diabetes met behulp van Ga-68-exendin PET
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The comparison of the number of insulin-producing cells during and shortly after the honeymoon phase of type 1 diabetes
    De vergelijking van het aantal insuline-producerende cellen tijdens en kort na de honeymoonfase van type 1 diabetes
    A.3.2Name or abbreviated title of the trial where available
    GLP1-honeymoon
    GLP1-honeymoon
    A.4.1Sponsor's protocol code numberGLP1-honeymoon
    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 supportRadboudumc
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud university medical center
    B.5.2Functional name of contact pointDepartment of Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailtom.jp.jansen@radboudumc.nl
    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 Byetta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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-NODAGA-[K40]-Exendin-4
    D.3.4Pharmaceutical form Radiopharmaceutical precursor, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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
    Type 1 diabetes
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes
    Suikerziekte 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 20.0
    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
    The primary study objective is to determine the beta cell mass in subjects with type 1 diabetes during and shortly after the honeymoon phase, to examine possible differences in beta cell mass and to improve understanding of the change in metabolic control after the honeymoon phase.
    Het primaire doel van de studie is om de bètacel-massa bepalen in proefpersonen met type 1 diabetes tijdens en kort na de honeymoonfase, om onderzoek te doen naar de mogelijke verschillen in bètacel-massa and om een beter begrip te krijgen van de verandering in metabole regulatie na de honeymoonfase.
    E.2.2Secondary objectives of the trial
    The secondary aim is to correlate the beta cell mass to the beta cell function from the measurements that will be performed during and shortly after the honeymoon phase.
    Het secundaire doel is om de bètacel-massa te correleren met de bètacel-functie van de metingen die gedaan zijn tijdens en kort na de honeymoonfase.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    - Age ≥16 years
    - Subject is diagnosed with type 1 diabetes (T1D)
    - Presence of anti-GAD (glutamic acid decarboxylase)
    - Subject is in the honeymoon phase of T1D: IDAA1c <9
    - 17≤ BMI ≤30 kg/m^2
    - Ability to sign informed consent
    Inclusiecriteria: honeymoonfase
    - Leeftijd ≥16 jaar
    - Proefpersoon is gediagnosticeerd met type 1 diabetes (T1D)
    - Aanwezigheid van anti-GAD (glutamic acid decarboxylase)
    - Proefpersoon bevindt zich in de honeymoonfase van T1D: IDAA1c<9
    - 17≤ BMI ≤30 kg/m^2
    - Het vermogen om het toestemmingsformulier te ondertekenen
    E.4Principal exclusion criteria
    Exclusion criteria:
    - Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase lV
    inhibitors
    - Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of the normal range
    - Renal disease defined as MDRD <40 ml/min/1.73 m^2
    - Pregnancy or the wish to become pregnant within 6 months after the study
    - Breastfeeding
    - BMI <17 kg/m^2 or BMI >30 kg/m^2
    - Age <16 years
    - When the end of the honeymoon phase (IDAA1c ≥9) is not observed within 11 to 13 months after the inclusion of the subject
    - lnability to sign informed consent
    Exclusiecriteria:
    - Eerdere behandeling met synthetisch Exendin (Exenatide, Byetta®) of Dipeptidyl-Peptidase lV inhibitors in de afgelopen 6 maanden
    - Leverziekte, gedefinieerd als een asparaat aminotransferase of alanine aminotransferase waarde van meer dan drie keer de bovengrens van de normaalwaarde
    - Nierziekte, gedefinieerd als een MDRD <40 ml/min/1.73 m^2
    - Zwanger of de wens om zwanger te worden binnen 6 maanden na de studie
    - Geven van borstvoeding
    - BMI <17 kg/m^2 of BMI >30 kg/m^2
    - Leeftijd <16 jaar
    - Wanneer het einde van de honeymoonfase (IDAA1c ≥9) niet binnen 11 tot 13 maanden na de inclusie van de proefpersoon wordt waargenomen
    - Het onvermogen om schriftelijke toestemming te geven
    E.5 End points
    E.5.1Primary end point(s)
    The primary study objective is to determine the beta cell mass in subjects with type 1 diabetes during and shortly after the honeymoon phase, to examine the differences in beta cell mass and to improve understanding of the change in metabolic control after the honeymoon phase.
    Het primaire doel van de studie is om de bètacel-massa bepalen in proefpersonen met type 1 diabetes tijdens en kort na de honeymoonfase, om onderzoek te doen naar de verschillen in bètacel-massa en om een beter begrip te krijgen van de verandering in metabole regulatie na de honeymoonfase.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 hour after the administration of the tracer (for both scans)
    1 uur na toediening van de tracer (voor beide scans)
    E.5.2Secondary end point(s)
    The secondary aim is to correlate the beta cell mass to the beta cell function from the measurements that will be performed during and shortly after the honeymoon phase.
    Het secundaire doel is om de bètacel-massa te correleren met de bètacel-functie van de metingen die gedaan zijn tijdens en kort na de honeymoonfase.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the analysis of the mixed-meal tolerance tests and PET/CT scans
    Na de analyse van de maaltijdstimulatietesten en PET/CT scans
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    In this study we will determine the beta cell mass as well as the beta cell function in T1D patients during and shortly after the honeymoon phase. This will improve understanding of the change in metabolic control after the honeymoon phase. An increased understanding might provide new insights for the development of novel therapies. (Noting that diagnosis of T1D was already done as stated in the inclusion criteria)
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Herhaalde metingen: proefpersoon is ook de controle (2 metingen voor elke proefpersoon)
    Repeated measures: subject is also the control(2 measurements in each subject)
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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 Yes
    F.1.1Number of subjects for this age range: 18
    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: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    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 Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Subjects with an age of 16 and 17 years old (included subjects of 16 years and older)
    Proefpersonen met een leeftijd van 16 en 17 jaar oud (geincludeerde proefpersonen vanaf 16 jaar)
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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