Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38870   clinical trials with a EudraCT protocol, of which   6391   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-000794-20
    Sponsor's Protocol Code Number:20160218
    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:2016-08-30
    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 number2016-000794-20
    A.3Full title of the trial
    Visualizing beta cells in patients with a history of gestational diabetes
    Beeldvorming van beta cellen in patienten met een geschiedenis van zwangerschapsdiabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging beta cells after gestational diabetes
    Beeldvorming van beta cellen na zwangerschapsdiabetes
    A.3.2Name or abbreviated title of the trial where available
    GLP-1-gestational
    A.4.1Sponsor's protocol code number20160218
    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 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 BV
    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
    Gestational diabetes
    zwangerschapsdiabetes
    E.1.1.1Medical condition in easily understood language
    Pregnancy Diabetes
    zwangerschapsdiabetes
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10018209
    E.1.2Term Gestational diabetes
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    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 a history of gestational diabetes by quantitative analysis of PET images.
    Het primaire doel is het evalueren van het verschil in 68Ga-exendin tracer opname in de pancreas van patienten met en zonder een geschiedenis van zwangerschapsdiabetes door middel van kwantitatieve analyse van PET beelden.
    E.2.2Secondary objectives of the trial
    To determine the correlation between 68Ga-exendin tracer accumulation and beta cell function of the subjects as assessed by oral glucose tolerance testing
    Het bepalen van de correlatie tussen 68Ga-exendin tracer opname en beta cel functie van de proefpersonen bepaald door middel van orale glucose-tolerantietest
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria (women with history of GDM)
    - Pregnancy with diagnosis of GDM, within the last 5 years
    - No other previous pregnancies
    - Complete resolution of GDM after delivery (HbA1c in normal range, fasting glucose < 100 mg/dl for at least 1 year in the absence of active pharmacologic therapy or ongoing procedures)
    - Signed informed consent

    Inclusion criteria (women without history of GDM)
    - Pregnancy without problems in glucose homeostasis, within the last 5 years
    - No other previous pregnancies
    - No evidence of T2D at time of inclusion (HbA1c in normal range, fasting glucose < 100 mg/dl for at least 1 year in the absence of active pharmacologic therapy)
    - Insulin secretion-sensitivity index-2 (ISSI-2) ≥ 800 on oral glucose tolerance test
    - Signed informed consent
    Inclusiecriteria (vrouwen met een geschiedenis van zwangerschapsdiabetes)
    - Zwangerschap met een diagnose van zwangerschapsdiabetes binnen de afgelopen 5 jaar
    - Geen eerdere zwangerschappen
    - Complete resolutie van zwangerschapsdiabetes na de bevalling
    - getekend toestemmingsformulier

    Inclusiecriteria (vrouwen zonder een geschiedenis van zwangerschapsdiabetes)
    - zwangerschap zonder problemen met glucose-homeostase in de afgelopen 5 jaar
    - geen andere eerdere zwangerschappen
    - Geen bewijs voor type 2 diabetes op het tijdstip van inclusie
    - Insuline-secretie-sensitiviteits index-2 (ISSI-2) > 800 op oral glucose-tolerantietest
    - getekend toestemmingsformulier
    E.4Principal exclusion criteria
    Exclusion criteria
    - Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
    - Breast feeding
    - Current pregnancy or the wish to become pregnant within 6 months
    - Renal dysfunction (Calculated creatinine clearance below 40ml/min)
    - Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
    - Age < 18 years
    - Incapacitated
    - No signed informed consent
    Exclusiecriteria:
    - eerder behandelijk met synthetisch exendin
    - borstvoeding
    - huidige zwangerschap of de wens om binnen 6 maanden zwanger te worden
    - Nierfunctiestoornissen
    - Leverfunctiestoornissen
    - leeftijd < 18 jaar
    - gehandicapt
    - geen getekende toestemming
    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 women with and without a history of GDM by PET/CT.
    De kwantitatieve analyse van opname van 68Ga-exendin-4 in de pancreas van vrouwen met en zonder zwangerschapsdiabetes
    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 correlation between Ga-exendin tracer accumulation and beta cell function of the subjects
    De correlatie tussen Ga-exendin tracer opname en de beta cel functie van de deelnemers
    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 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
    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 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 months0
    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 No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-08-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.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
    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 Decision2016-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA