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    Summary
    EudraCT Number:2016-001221-14
    Sponsor's Protocol Code Number:E.G.R.A.B.I.N.S1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-22
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-001221-14
    A.3Full title of the trial
    Effect of glucagon-like peptide 1 (GLP-1) based diabetes medication on
    blood flow velocity in persons without cerebrovascular disease.
    Effekt af glukagon-lignende peptid 1 (GLP-1) baseret sukkersygemedicin
    på blodgennemstrømningshastigheden i hjernen hos personer uden cerebrovaskulær lidelse.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GLP-1 and persons without stroke.
    GLP-1 og personer uden slagtilfælde.
    A.3.2Name or abbreviated title of the trial where available
    GLP-1 and persons without cerebrovascular disease.
    GLP-1 og personer uden cerebrovaskulær lidelse
    A.4.1Sponsor's protocol code numberE.G.R.A.B.I.N.S1
    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 SponsorHerlev Gentofte Hospital
    B.1.3.4CountryDenmark
    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 supportHerlev Gentofte Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHerlev Gentofte Hospital
    B.5.2Functional name of contact pointChristina Rostrup Kruuse
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.4Telephone number4538681233
    B.5.6E-mailchristina.rostrup.kruuse@regionh.dk
    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 holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEXENATIDE
    D.3.9.1CAS number 141758-74-9
    D.3.9.4EV Substance CodeSUB21818
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboInjection
    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
    This is a healthy control group which is to be compared with patients with stroke.
    Forsøgspersonerne fungerer som en kontrolgruppe for patienter med apopleksi.
    E.1.1.1Medical condition in easily understood language
    Stroke
    Slagtilfælde.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system 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 investigate the effect of a single dose of 5 mikrogram GLP-1 receptor agonist ( exenatid ) on blood flow velocity and oxigination in
    persons without cerebrovascular disease.
    Formålet med dette forsøg er, at undersøge effekten af en enkeltdosis glukagon-lignende peptid 1 receptor agonist (GLP-1-RA) på blodgennemstrømningshastigheden og iltmætningen i hjernen hos personer uden cerebrovaskulær lidelse.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study is to investigate if the GLP-1 receptor agonist ( exenatid ) improves the peripheral endothelial function
    measured as an improved blood vessel respons in the fingers after a short occlusion of blood suply to the arm measured with endoPAT2000
    and by measuring the blood pressure in the ancles (ancle-brachial index). Besides of that is the objective to examine the endothelial
    function and inflammation through specific biomarkers.
    Sekundære formål med forsøget er, at undersøge GLP-1-RAs virkning på blodkarfunktionen perifert på fingrene målt ved EndoPAT og perifert i
    anklerne målt som ankel-brachialindex (ABI), samt at undersøge endothelfunktion og inflammation via specifikke biomarkører.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Person ≥ 50 years of age
    • Has given written informed consent

    • Alder ≥ 50 år
    • Har afgivet skriftligt informeret samtykke
    E.4Principal exclusion criteria
    • Intracerebral haemorrhage
    • Subdural / epidural hemorrhage
    • subarachnoid haemorrhage
    • previously major structural damage to the brain (eg. sequelae after
    large stroke or brain surgery)
    • Type 1 diabetes
    • Type 2 diabetes
    • Known atrial fibrillation
    • > 50% stenosis of halskar
    • Known allergy to GLP-1 RA preparations
    • Hepatic impairment (ALT> 3 x upper normal limit)
    • Renal impairment (eGFR <30 ml / min)
    • Inflammatory bowel disease
    • Previous pancreatitis
    • Heart failure (NYHA class 3-4)
    • Pregnancy or lactation
    • Patient is not expected to co-operate to the investigations
    • Visualization of the middle cerebral artery bilaterally by transcraniel doppler not possible
    • Intracerebral blødning
    • Subdural/epidural blødning
    • Subarachnoidal blødning
    • Tidl. større strukturel skade på hjernen (eks. sequelae efter tidl. stor
    blodprop eller hjernekirurgi)
    • Type 1 sukkersyge
    • Type 2 sukkersyge
    • Kendt atrieflimmer
    • > 50% stenose af halskar
    • Kendt allergi overfor GLP-1-RA præparater
    • Nedsat leverfunktion (ALAT > 3 x øvre normalgrænse)
    • Nedsat nyrefunktion (eGFR < 30 ml/min)
    • Inflammatorisk tarmsygdom
    • Tidligere pancreatit
    • Hjertesvigt (NYHA klasse 3-4)
    • Graviditet eller amning
    • Patient der ikke forventes at kunne kooperere til undersøgelserne
    • Visualisering af a. cerebri media bilateralt ved TCD ej mulig
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is changes in the mean blood flow velocity (Vmean) in the middle cerebral artery and the cortical oxigination.
    Primær endpoint er ændringer i blodets middelstrømningshastighed (Vmean ) i a. cerebri media og cortikal iltmætning .
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to three hours after injection of exenatid.
    Op til tre timer efter injektion af exenatid.
    E.5.2Secondary end point(s)
    - Changes in peripheral vascular function measured by EndoPAT and
    changes in the ancle-brachial index
    - Changes in inflammatory- and endothelial function markers in the
    blood.
    - Ændring i perifert karfunktion målt med EndoPAT og ændringer i ankelbrachial-indexet
    - Ændring af inflammatoriske- og karspecifikke markører i blodet.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to three hours after injection of exenatid.
    Op til tre timer efter injektion af exenatid.
    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 Yes
    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) Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 2016-03-22. 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 state30
    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.
    Ingen.
    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 Decision2016-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-02
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