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    Summary
    EudraCT Number:2014-005554-20
    Sponsor's Protocol Code Number:NL51854.091.14
    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:2015-07-20
    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 number2014-005554-20
    A.3Full title of the trial
    Visualizing beta cells in patients with postprandial hyperinsulinemic hypoglycemia after bariatric surgery
    Beeldvorming van beta cellen in patiënten met postprandiale hyperinsulinemische hypoglycaemie na bariatrische chirurgie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Visualizing beta cells in patients with postprandial hyperinsulinemic hypoglycemia after bariatric surgery
    Beeldvorming van beta cellen in patiënten met postprandiale hyperinsulinemische hypoglycaemie na bariatrische chirurgie
    A.3.2Name or abbreviated title of the trial where available
    Visualizing beta cells in post-bariatric hypoglycemia
    Beeldvorming van beta cellen bij hypoglycaemia na bariatrische chirurgie
    A.4.1Sponsor's protocol code numberNL51854.091.14
    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 Nijmegen
    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 Nijmegen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRijnstate hospital
    B.5.2Functional name of contact pointDepartment of surgery
    B.5.3 Address:
    B.5.3.1Street AddressWagnerlaan 55
    B.5.3.2Town/ cityArnhem
    B.5.3.3Post code6815 AD
    B.5.3.4CountryNetherlands
    B.5.6E-mailldeden@rijnstate.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 name68-Ga-NODAGA-[K40]-Exendin4
    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
    Hyperinsulinaemic hypoglycaemia after Roux-en-Y gastric bypass surgery
    Hyperinsulinaemische hypoglycaemie na Roux-en-Y gastric bypass chirurgie
    E.1.1.1Medical condition in easily understood language
    Hyperinsulinaemic hypoglycaemia after Roux-en-Y gastric bypass surgery
    Hyperinsulinaemische hypoglycaemie na Roux-en-Y gastric bypass chirurgie
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10059035
    E.1.2Term Postprandial hypoglycaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10018424
    E.1.2Term Glucose metabolism disorders (incl diabetes mellitus)
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10060378
    E.1.2Term Hyperinsulinaemia
    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 main objective is to examine if 68Ga-exendin tracer accumulation (i.e. beta cell mass) differs in patients with persisting HH after RYGB compared to matched patients without HH after RYGB.
    Het primaire doel van dit onderzoek is om de opname van 68Ga-exendin-4 in de pancreas te bepalen bij patiënten die een RYGB hebben ondergaan en wel en geen HH hebben te vergelijken middels een PET beelden.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - determine the correlation between measured 68Ga-exendin accumulation and beta cell function and
    - evaluate if a (focal) increase in beta cell mass is the underlying cause of HH in a part of the patients with persisting HH.
    De secondaire doelen zijn:
    - de relatie bepalen tussen de gemeten 68Ga-exendin stapeling in de pancreas en de beta cel functie.
    - onderzoeken of een (focale) toename van beta cel massa de mogelijke oorzaak kan zijn van HH in een deel van de patientengroep.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    HH group
    - Signed informed consent
    - >18
    - Persisting hyperinsulinemic hypoglycemia after a low-carbohydrate diet and/or insulin suppressive medication for one year.

    Control group
    - Signed informed consent
    - >18
    - RYGB at least 2 years ago
    - Normal glucose levels before and after RYGB (fasting glucose between 4 and 6 mmol/l and/or HbA1c between 20 and 42 mmol/mol)
    - Individual matched to HH group on age (± 5 years), sex and BMI at time of inclusion (± 2 kg/m2)
    HH groep
    - Getekende informed consent
    - > 18 jaar
    - Persisterende hyperinsulinemische hypoglycaeamia na therapie met een koolhydraatarm dieet en/of insuline verlagende medicatie

    Controle groep
    - Getekende informed consent
    - > 18 jaar
    - RYGB minimaal 2 jaar geleden ondergaan
    - Normale glucosewaarden voor en na de gastric bypass operatie (RYGB) (nuchtere glucose tussen 4 en 6 mmol/l en/of HbA1c tussen 20 en 42 mmol/mol)
    - Individueel gematcht met HH groep voor leeftij (± 5 jaar), geslacht en BMI op moment van inclusie (± 2 kg/m2)
    E.4Principal exclusion criteria
    HH group
    - Anti-diabetic medication in the past 6 months
    - Previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
    - Known liver failure or serum liver values over 2 times the normal values.
    - Pregnancy or the wish to become pregnant within 6 months
    - Breast feeding
    - Kidney failure, i.e. calculated creatinine clearance below 40 ml/min
    - Age < 18 years
    - No signed informed consent

    Additional exclusion for controle group
    - Any diabetic history (e.g. including diabetes during pregnancy)
    - Previous diagnosed HH or hypoglycemia
    HH group
    - Anti-diabetische medicatie gebruikt in de afgelopen 6 maanden
    - Eerdere behandeling met synthetische Exendin (Exenatide, Byetta®) of een Dipeptidyl-Peptidase IV inhibitor
    - Bekendeleverfalen of serum lever waarden meer dan 2 keer de normale waarden.
    - Zwanger, of de wens om zwanger te worden in de komende 6 maanden.
    - Borst voeding
    - Nierfalen, ofwel een creatinine klaring lager dan 40 ml/min
    - Jonger dam 18
    - Geen getekende informed consent

    Additionele exclusie criteria voor controle groep
    - Enige diabetische geschiedenis (inclusief zwangerschapsdiabetes)
    - Eerder gediagnosticeerde HH of hypoglycemie
    E.5 End points
    E.5.1Primary end point(s)
    The main parameter of the study is the quantitative assessment of pancreatic 68Ga-NODAGA-exendin-4 uptake in patients suffering from persisting HH after RYGB and matched controls.
    De primaire parameter in deze studie is de kwantitatieve bepaling van de opname van 68Ga-exendin-4 in de pancreas bij post-RYGB patiënten met en zonder HH middels PET-CT beelden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 hour after injection of the radiotracer the PET scan is performed.
    1 uur na het toedienen van de radiotracer wordt de PET scan gemaakt.
    E.5.2Secondary end point(s)
    Secondary endpoints are the pancreatic distribution of 68Ga-exendin-4 as assessed by experts from the nuclear medicine department and the correlation between pancreatic 68Ga-exendin-4 uptake and beta cell function.
    Secundaire variabelen zijn de verdeling van 68Ga-exendin-4 in de pancreas en de correlatie tussen de opname van 68Ga-exendin-4 in de pancreas en de beta cel functie bij post-RYGB patiënten met en zonder HH middels PET-CT beelden.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 hour after injection of the radiotracer the PET scan is performed.
    1 uur na het toedienen van de radiotracer wordt de PET scan gemaakt.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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
    Feasibility
    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 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 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 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 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 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 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: 24
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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
    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 Decision2015-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-12-17
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