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    Summary
    EudraCT Number:2014-004317-90
    Sponsor's Protocol Code Number:NL51058.091.14
    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:2015-01-07
    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 number2014-004317-90
    A.3Full title of the trial
    Visualizing beta cells in patients with remission of T2DM after bariatric surgery
    Beeldvorming van beta cellen in patienten met remissie van type 2 diabetes 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 remission of T2DM after bariatric surgery
    Beeldvorming van beta cellen in patienten met remissie van type 2 diabetes na bariatrische chirurgie
    A.3.2Name or abbreviated title of the trial where available
    Visualizing beta cells after bariatric surgery
    Beeldvorming van beta cellen na bariatrische chirurgie
    A.4.1Sponsor's protocol code numberNL51058.091.14
    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 organisationRadboud University Medical Center Nijmegen
    B.5.2Functional name of contact pointDepartment of nuclear medicine
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein 8
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailmarti.boss@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 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
    Patients with Type 2 Diabetes, with or without remission after bariatric surgery
    Patienten met Type 2 Diabetes, met of zonder remissie na bariatrische chirurgie
    E.1.1.1Medical condition in easily understood language
    Patients with Type 2 Diabetes, with or without remission after bariatric surgery
    Patienten met Type 2 Diabetes, met of zonder remissie na bariatrische 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 17.1
    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 17.1
    E.1.2Level HLT
    E.1.2Classification code 10012602
    E.1.2Term Diabetes mellitus (incl subtypes)
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term 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 objective is to evaluate the difference in 68Ga-exendin tracer accumulation in the pancreas of patients with and without complete resolution of T2DM after RYGB by quantitative analysis of PET images.
    Het primaire doel is om het verschil in de opname van de radioactief gelabelde tracer 68Ga-exendin in de pacreas van patienten met en zonder complete remissie van type 2 diabetes na het ondergaan van een Roux en Y gastric bypass operatie te vergelijken door middel van kwantitatieve analyse van PET beelden.
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine the correlation between 68Ga-exendin tracer
    accumulation and beta cell function of the patients as assessed by oral glucose tolerance
    testing and arginine stimulation.
    Het secundaire doel in om de correlatie te bepalen tussen de opname van 68Ga-exendin en de beta cel-functie van patienten, bepaald dmv glucose-tolerantietest and arginine-stimulatie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Responders:
    - Obese T2D patient who has undergone RYGB at least one year earlier
    - Signed informed consent
    - Complete resolution of T2DM after surgery (HbAl c in normal range, fasting glucose <100 mg/dl for at least I
    year in the absence of active pharmacologic therapy or ongoing procedures)
    non-responders:
    - Obese T2D patient who has undergone RYGB at least one year earlier
    - Signed informed consent
    - No complete resolution of T2DM after surgery (still requires treatment with oral hypoglycaemic agents or insulin)
    Responders:
    - Obese Type 2 Diabetes patienten die ten minste een jaar geleden een Roux en Y Gastric bypass operatie gehad
    hebben
    - Getekend toestemmingsformulier
    - Complete resolutie van type 2 diabetes na de operatie (HbAl c in normale range, nuchter glucose < 100 mg/dl
    voor tenminste 1 jaar zonder actieve farmacologische therapie of gaande procedures
    Non-responders:
    - Obese Type 2 Diabetes patienten die tenminste een jaar geleden een Roux en Y gastric bypass operatie hebben
    ondergaan
    - getekend toestemmingsformuher
    - Geen complete resolutie van Type 2 Diabetes na de operatie (nog steeds afhankelijk van orale
    glucoseverlagende middelen of insuline)
    E.4Principal exclusion criteria
    - Previous treatment with synthetic Exendin (Exenatide, Byetta@) or Dipeptidyl-Peptidase lV inhibitors
    - Breast feeding
    - Pregnancy or the wish to become pregnant within 6 months
    - Calculated creatinine clearance below 4Oml/min
    - Age . 18 years
    - No signed informed consent
    - Voorafgaande behandeling met synthetische Exendin (Exenatide, Byetta@) of Dipeptidyl-Peptidase lV inhibitoren
    - Borstvoeding gevend
    - Zwangerschap of de wens om binnen 6 maanden zwanger te worden
    - Berekende creatinineklaring lager dan 40ml/min
    - Leeftijd < 18 jaar
    - Geen getekend toestemmingsformulier
    E.5 End points
    E.5.1Primary end point(s)
    The main parameter of the study is the quantitative assessment of pancreatic 68Ga-NODAGA-exendin4 uptake in responders and non-responders after RYGB by PET/CT.
    De primaire ondezoeksvariabele is de kwantitatieve bepaling van opname ven 68Ga-NODAGA-exendin-4 in de pancreas van responders en non-responders na Roux en Y gastric bypass operatie door middel van PET/CT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 hour after injection of the tracer
    1 uur na injectie van de tracer
    E.5.2Secondary end point(s)
    The secondary endpoint is to the correlation between 68Ga-exendin tracer accumulation and beta cell function of the patients.
    De secundaire onderzoeksvariabele is de correlatie tussen opname van 68Ga-exendin in de pancreas van de patienten en de beta cel functie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 hour after injection of the tracer
    1 uur na injectie van de tracer
    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) 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 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 days0
    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 Decision2015-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-25
    P. End of Trial
    P.End of Trial StatusOngoing
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