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    Summary
    EudraCT Number:2018-003566-13
    Sponsor's Protocol Code Number:GLP1-hypofyse
    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:2018-10-17
    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 number2018-003566-13
    A.3Full title of the trial
    iPAVE – imaging Pituitary ActiVation by Exendin
    iPAVE - beeldvorming van hypofyse activatie door exendin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of treatment with GLP-1 receptor agonists on the HPA-axis in type 2 diabetes
    Effecten van de behandeling met GLP-1 receptor agonisten op de HPA-as in type 2 diabetes
    A.3.2Name or abbreviated title of the trial where available
    GLP1-hypophysis
    GLP1-hypofyse
    A.4.1Sponsor's protocol code numberGLP1-hypofyse
    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 2 diabetes
    Type 2 diabetes
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Suikerziekte type 2
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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
    The main study parameter is the comparison of pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.
    Het primaire doel van de studie is de vergelijking van de hypofyse-opname van 68Ga-NODAGA-exendin in patiënten met en zonder adequate respons (gebaseerd op HbA1c of gewichtsverlies) op GLP-1R agonist behandeling.
    E.2.2Secondary objectives of the trial
    To assess the metabolic status of the patients by obtaining laboratory parameters, oral glucose tolerance testing, stimulated ACTH assay and urinary cortisol excretion tests.
    De metabole status van patiënten te bepalen door middel van laboratoriumwaarden, een orale glucose tolerantie test, gestimuleerde ACTH-test en cortisolbepalingen in de urine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria (patients with treatment response)
    - Age ≥18 years
    - Subject is diagnosed with type 2 diabetes
    - Subject showed response to GLP-1RA treatment (decrease in HbA1c ≥5 mmol/mol and/or weight loss ≥5%)
    - Ability to sign informed consent

    Inclusion criteria (patients without treatment response)
    - Age ≥18 years
    - Subject is diagnosed with type 2 diabetes
    - Subject showed no response to GLP-1RA treatment (decrease in HbA1c <5 mmol/mol and no weight loss)
    - Ability to sign informed consent
    Inclusiecriteria (patiënten met respons op behandeling)
    - Leeftijd ≥18 jaar
    - Deelnemer is gediagnosticeerd met type 2 diabetes
    - Deelnemer laat een respons op GLP-1RA behandeling zien (afname in HbA1c ≥5 mmol/mol en/of gewichtsverlies ≥5%)
    - Het vermogen om het toestemmingsformulier te ondertekenen

    Inclusiecriteria (patiënten zonder respons op behandeling)
    - Leeftijd ≥18 jaar
    - Deelnemer is gediagnosticeerd met type 2 diabetes
    - Deelnemer laat geen respons op GLP-1RA behandeling zien (afname in HbA1c <5 mmol/mol en geen gewichtsverlies)
    - Het vermogen om het toestemmingsformulier te ondertekenen
    E.4Principal exclusion criteria
    Exclusion criteria:
    - 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
    - Age <18 years
    - Pituitary disorder
    - lnability to sign informed consent
    Exclusiecriteria:
    - 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
    - Leeftijd <18 jaar
    - Aandoening van hypofyse
    - Het onvermogen om schriftelijke toestemming te geven
    E.5 End points
    E.5.1Primary end point(s)
    The main study parameter is the comparison of pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.
    Het primaire doel van de studie is de vergelijking van de hypofyse-opname van 68Ga-NODAGA-exendin in patiënten met en zonder adequate respons (gebaseerd op HbA1c of gewichtsverlies) op GLP-1R agonist behandeling
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.5 hour after the administration of the tracer
    1.5 uur na toediening van de tracer
    E.5.2Secondary end point(s)
    To assess the metabolic status of the patients by obtaining laboratory parameters, oral glucose tolerance testing, stimulated ACTH assay and urinary cortisol excretion tests.
    De metabole status van patiënten te bepalen door middel van laboratoriumwaarden, een orale glucose tolerantie test, gestimuleerde ACTH-test en cortisolbepalingen in de urine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the analysis of all tests and PET/CT scan
    Na de analyse van alle testen en PET/CT scan
    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 compare the pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment, to increase understanding of the role of the HPA axis in T2D that could contribute to the improvement and development of novel treatment strategies (noting that diagnosis of T2D 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
    2 patiënten groepen: 1 groep liet een behandelingseffect zien, de tweede groep niet
    2 patient groups: 1 group showed treatment response, the second group showed no adequate response
    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 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
    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 months3
    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: 20
    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 state20
    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 Decision2018-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-02
    P. End of Trial
    P.End of Trial StatusOngoing
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