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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2016-000790-21
    Sponsor's Protocol Code Number:ESR-15-10862
    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:2016-09-20
    Trial results View 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 number2016-000790-21
    A.3Full title of the trial
    Effect of the GLP-1 receptor agonist exenatide on impaired hypoglycaemic awareness in type 1 diabetes
    Effect van de GLP-1 receptor agonist exenatide op verminderde hypoglykemie symptoomgewaarwording (awareness) bij mensen met type 1 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To investigate whether treatment with the GLP-1 receptor agonist exenatide improves the perception of hypoglycaemia in people with type 1 diabetes with impaired awareness of hypoglycaemia
    Het effect van behandeling met de GLP-1 receptor agonist exenatide op verminderde hypoglykemie symptoomgewaarwording (awareness) bij mensen met type 1 diabetes die hypo's niet (goed) voelen
    A.3.2Name or abbreviated title of the trial where available
    Exenatide and impaired hypoglycaemic awareness in T1DM
    Exenatide en verminderde hypoglykemie awareness in T1DM
    A.4.1Sponsor's protocol code numberESR-15-10862
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02735031
    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 SponsorRadboudumc
    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 supportAstra-Zeneca
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointLian van Meijel
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein-Zuid 8
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31243613286
    B.5.6E-mailLian.vanMeijel@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 Exenatide 5 and 10 microgram
    D.2.1.1.2Name of the Marketing Authorisation holderAstra-Zeneca
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameExenatide
    D.3.4Pharmaceutical form Suspension for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    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
    Diabetes, Sugar disease
    Suikerziekte
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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
    To investigate the effect of treatment with the GLP-1ra exenatide on the awareness of and counterregulatory hormone responses to hypoglycaemia in people with type 1 diabetes and impaired hypoglycaemic awareness
    Onderzoeken van effect van behandeling met de GLP-1 receptor agonist exenatide op de symptomatologie van en hormonale respons op hypoglykemieën bij patiënten met type 1 diabetes en verminderde hypoglykemie awareness (IHA, impaired hypoglycaemic awareness).

    E.2.2Secondary objectives of the trial
    To investigate the effect of treatment with the GLP-1ra exenatide on the glycaemic recovery from hypoglycaemia and the post-hypoglycaemic glucose excursion in people with type 1 diabetes and impaired hypoglycaemic awareness
    Onderzoeken van effect van behandeling met de GLP-1 receptor agonist exenatide op het glucoseherstel en de mate van glucosestijging na hypoglykemie bij patiënten met type 1 diabetes en verminderde hypoglykemie awareness (IHA, impaired hypoglycaemic awareness)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Type 1 diabetes, disease duration >1 year
    • Age >18 years, <70 years
    • Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
    • Impaired hypoglycaemic awareness as assessed by a score of 3 or more on the modified Dutch translation of the Clarke questionnaire
    • Glycated haemoglobin (HbA1c) ≥42 mmol/mol (6%) and ≤75 mmol/mol (9.0%)
    • Ability to provide informed consent
    • Type 1 diabetes met een duur van tenminste 1 jaar
    • Leeftijd ouder dan 18 jaar en jonger dan 70 jaar
    • Insulinebehandeling volgens het zg. basaal-bolus principe met injecties of een subcutane pomp
    • Impaired hypoglycaemic awareness gedefinieerd als tenminste 3 punten (van max. 5) op de in het Nederlands vertaalde IHA-vragenlijst van Clarke
    • HbA1c ≥42 mmol/mol (6%) en ≤75 mmol/mol (9.0%)
    • Voldoende in staat om informed consent te geven
    E.4Principal exclusion criteria
    • Treatment with incretin-based therapy (DPP-IV inhibitors or GLP-1RAs)
    • Known intolerance to GLP-1RAs (including allergy)
    • Treatment with glucose-modefying or immune-modefying agents, e.g. prednisolon
    • History of cardiovascular disease or laser coagulation for proliferative retinopathy (past 6 months)
    • Proliferative retinopathy
    • Symptomatic diabetic neuropathy
    • Diabetic nephropathy as reflected by albumin-creatinin ratio >30 mmol/mg or MDRD <60 ml/min/1.73 m2
    • Known heart failure
    • History of pancreatitis (acute or chronic) or pancreatic cancer
    • Body-mass index >40 kg/m2
    • Blood pressure >160/90 mmHg
    • Use of premixed insulin or of long-acting insulin alone
    • Total daily insulin dose requirements <20 units unless on pump treatment
    • Pregnancy or unwillingness to undertake measures for birth control
    • Behandeling met zg. op het incretineprincipe gebaseerde medicijnen, te weten DPP-IV remmers of GLP-1 receptor agonisten
    • Bekende intolerantie of allergie voor GLP-1 receptor agonisten
    • Behandeling met medicijnen die invloed hebben op het glucosemetabolisme of immuunsysteem, zoals prednisolon
    • Voorgeschiedenis van een hart- en vaatziekten of laserbehandeling voor proliferatieve retinopathie in de afgelopen 6 maanden
    • Proliferatieve retinopathie
    • Symptomatische diabetische neuropathie
    • Diabetische nefropathie, weerspiegeld door een albumine-kreatine ratio van >30 mmol/mg en/of een MDRD <60 ml/min/1.73 m2
    • Bekend hartfalen
    • Voorgeschiedenins van pancreatitis (acuut of chronisch) of pancreaskanker
    • Body-mass index >40 kg/m2
    • Bloeddruk >160/90 mmHg
    • Gebruik van voorgemixt insuline of behandeling met alleen langwerkend insuline
    • Totale insulinebehoefte van minder dan 20 eenheden per dag, tenzij behandeld met een insulinepomp
    • Zwangerschap of niet bereid tot het gebruiken van voorbehoedsmiddelen
    E.5 End points
    E.5.1Primary end point(s)
    Maximal symptom score in response to the hyperinsulinemic hypoglycaemic glucose clamp experiment
    Maximale symptoomscore tijdens het hyperinsulinemische hypoglykemische glucose clamp experiment
    E.5.1.1Timepoint(s) of evaluation of this end point
    During hypoglycaemic glucose clamp after 6 weeks
    Gedurende hypoglykemische glucose clamp na 6 weken behandeling
    E.5.2Secondary end point(s)
    - Responses of counterregulatory hormones (adrenaline, glucagon, cortisol, growth hormone) to the hyperinsulinemic hypoglycaemic glucose clamp
    - Time until glycaemic recovery from hypoglycaemia after the hyperinsulinemic glucose clamp
    - Maximal glucose excursion post-hypoglycaemia after the hyperinsulinemic glucose clamp
    - Time until glucose peak post-hypoglycaemia after the hyperinsulinemic glucose clamp
    - Area under the glucose concentration curve post-hypoglycaemia after the hyperinsulinemic glucose clamp
    - Hunger score post-hypoglycaemia after the hyperinsulinemic glucose clamp
    - Number of severe hypoglycaemic events during 6 weeks of treatment with exenatide or placebo
    - Number of nocturnal hypoglycaemic events during 6 weeks of treatment with exenatide or placebo
    - Number of any hypoglycaemic events during 6 weeks of treatment with exenatide or placebo
    - Number of hypoglycaemic events and time spent under hypoglyacemic conditions as measured by continuous glucose sensor monitoring
    - Glucose variability as measured by continuous glucose sensor monitoring
    - Vital signs during the hyperinsulinemic hypoglycaemic glucose clamp
    - Gastrointestinal adverse effects during 6 weeks of treatment with exenatide or placebo
    - Respons van de contraregulerende hormonen (adrenaline, glucagon, cortisol en groeihormoon) tijdens het hyperinsulinemische hypoglykemische glucose clamp experiment
    - Tijd tot herstel tot normoglykemie na afloop van de hyperinsulinemische hypoglykemische glucose clamp
    - Maximale glucosespiegel na afloop van de hyperinsulinemische hypoglykemische glucose clamp
    - Tijd tot maximale glucosepiek na afloop van de hyperinsulinemische hypoglykemische glucose clamp
    - Totale hyperglykemische belasting vanaf herstel tot normoglykemie
    - Mate van hongergevoel na herstel van hypoglykemie
    - Aantal ernstige hypoglykemieën tijdens 6 weken behandeling met exenatide of placebo
    - Aantal nachtelijke hypoglykemieën tijdens 6 weken behandeling met exenatide of placebo
    - Totaal aantal ernstige en niet-ernstige hypoglykemieën tijdens 6 weken behandeling met exenatide of placebo
    - Aantal hypoglykemieën en tijd in hypoglykemie gemeten met continue glucose sensor registratie
    - Glucosevariabiliteit gemeten met continue glucose sensor registratie
    - Vitale kenmerken gemeten tijdens de hyperinsulinemiscpe hypoglykemische glucose clamp
    - Gastrointestinale bijwerkingen tijdens 6 weken behandeling met exenatide of placebo
    E.5.2.1Timepoint(s) of evaluation of this end point
    During 6 weeks follow-up or during hypoglycaemic glucose clamp after 6 weeks
    Tijdens 6 weken behandeling of gedurende hypoglykemische glucose clamp na 6 weken behandeling
    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 Yes
    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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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
    laatste visite van de laatste patient
    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: 15
    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 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 state15
    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)
    Usual care will resume. There is no possibility to continue study medication.
    De gebruikelijke behandeling zal weer worden hervat; er is geen mogelijkheid studiemedicatie te continueren.
    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 Decision2016-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-04
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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