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    Summary
    EudraCT Number:2017-000841-28
    Sponsor's Protocol Code Number:DC2017DECREASE01
    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:2017-08-14
    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 number2017-000841-28
    A.3Full title of the trial
    Combined effects of SGLT2 inhibition and GLP-1 receptor agonism on food intake, body weight and central satiety and reward circuits in obese T2DM patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    De effects of the bloodglucose lowering drugs exenatide (GLP-1 receptor agonist) and dapagliflozine ( a SGLT2 inhibitor) on the brain, food intake and bodyweight.
    De effecten van de bloedsuiker-verlagende medicijnen exenatide (een GLP-1 receptor agonist) en dapagliflozine (een SGLT-2 remmer) op de hersenen, voedselinname en het lichaamsgewicht
    A.3.2Name or abbreviated title of the trial where available
    DECREASE, Dapagliflozine plus Exenatide and Central REgulation of Appetite in diabeteS typE 2
    A.4.1Sponsor's protocol code numberDC2017DECREASE01
    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 SponsorVU 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 supportAstraZeneca
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Center
    B.5.2Functional name of contact pointLotje C.C. van Ruiten
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117, Room ZH 4A65
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031204440541
    B.5.5Fax number0031204443349
    B.5.6E-mailc.ruiten@vumc.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 holderAstra Zeneca AB
    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 nameexenatide
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    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.IMP: 2
    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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca AB
    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 namedapagliflozin
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 placeboConcentrate and solvent for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes mellitus
    Obesity
    diabetes type 2
    obesitas
    E.1.1.1Medical condition in easily understood language
    diabetes
    overweight
    suikerziekte
    overgewicht
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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 separate and combined actions of the SGLT2 inhibitor dapagliflozin and GLP-1 receptor agonist exenatide BID on activity in central reward and satiety circuits in response to food related stimuli in obese patients with T2DM
    E.2.2Secondary objectives of the trial
    To investigate the separate and combined actions of the SGLT2 inhibitor dapagliflozin and GLP-1 receptor agonist exenatide on quantitative and qualitative aspects of food intake, energy expenditure, anthropometrics, resting state brain activity networks, cardiovascular autonomic nervous function and blood and urine biomarkers

    Safety objectives:
    To evaluate the safety and tolerability of the separate and combined actions of the SGLT2 inhibitor dapagliflozin and GLP-1 receptor agonist exenatide

    Exploratory objectives:
    -to study the possible influence of concomitant changes in several important hormones and novel hormone measurements that may become available in the near future.
    -to allow the study of the effects of human genetic variation on the endpoints in the future
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-65 years
    - BMI 30–40 kg/m2
    - Stable bodyweight (<5% reported change during the previous 3 months).
    - Diagnosed with T2DM > 3 months prior to screening
    - HbA1C 7.5–10%
    - Treatment with metformin and/or sulphonylurea at a stable dose for at least 3 months.
    - Right handed
    - Both genders; for women: post menopausal (excluding possible menstruation cycle effects)
    - Caucasian
    - leeftijd 18-65jaar
    - BMI 30–40 kg/m2
    - stabiel lichaamsgewicht (5% verschil in afgelopen 3 maanden)
    - > 3 maanden voor screening gediagnosticeerd met T2Dm
    - HbA1C 7.5–10%
    - behandeling met metformine en/of sulfonyluremderivaat op een stabiele dosis ten minste gedurende 3 maanden
    - rechtshandigheid
    - Mannen en vrouwen; voor vrouwen: post menopauzaal
    - Kaukasisch
    E.4Principal exclusion criteria
    - GLP-1 based therapies, DPP-4 inhibitors, thiazolidinediones or insulin within 3 months before screening
    - Weight-lowering agents within 3 months before screening.
    - Congestive heart failure (NYHA II-IV)
    - Chronic renal failure (glomerular filtration rate < 60 mL/min/1.73m2 per Modification of Diet in Renal Disease (MDRD))
    - Liver disease
    - History of gastrointestinal disorders (including gastroparese, pancreatitis and cholelithiasis)
    - Patients with MEN2 syndrome or history or family history of medullary thyroid carcinoma
    - Neurological illness
    - Malignancy (except for basal cell carcinoma)
    - History of major heart disease
    - History of major renal disease
    - Pregnancy or breast feeding
    - Implantable devices
    - Substance abuse
    - Addiction
    - Alcohol abuse (defined as: for men > 21 units/week, for women >14 units/week)
    - Smoking/ nicotine abuse (defined as: daily smoking / a daily use of nicotine)
    - Contra-indication for MRI, such as claustrophobia or pacemaker
    - Any psychiatric illness; including eating disorders and depression
    - Chronic use of centrally acting agents or glucocorticoids within 2 weeks immediately prior to screening.
    - Use of cytostatic or immune modulatory agents
    - History of allergy for exenatide or other GLP-1 RA
    - Participation in other studies at time of the screening visit
    - Individuals who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
    - Therapie met GLP-1 analogen, DPP-4 remmers, thiazolidinedionen of insuline 3 maanden voorafgaand aan screening
    - gebruikt van gewichtsreducerende middelen 3 maanden voorafgaand aan screening
    - congestief hartfalen (NYHA II-IV)
    - Chronische nierinsufficiëntie (glomerulaire filtratie < 60 mL/min/1.73m2 per Modification of Diet in Renal Disease (MDRD))
    - Leverziekte
    - Geschiedenis van gastro-intestinale ziekten ( inclusief gastroparese, pancreatitis en cholelithiasis)
    - patienten met MEN2 syndroom of medische (familie) geschiedenis met medullair thyroid carcinoom
    - neurologische ziekten
    - maligniteit (behalve basaal-cel carcinoom)
    - medische geschiedenis met belangrijke hart ziekte
    - medische geschiedenis met belangrijke nierziekte
    - zwangerschap of borstvoeding
    - implanteerbare medische apparaten
    - middelen misbruik
    - verslaving
    - Alcohol misbruik ( gedefinieerd als: voor mannen > 21 eenheden/week, voor vrouwen > 14 eenheden/week)
    - Roken/nicotine misbruik ( gedifinieerd als: dagelijks roken/ dagelijks gebruik van nicotine)
    - contra-indicaties voor MRI, zoals claustrofobie of (niet mri compatible) pacemaker
    - elke psychiatrische ziekte; inclusief eetstoornissen en depressie
    - chronisch gebruik van centraal werkende middelen of glucocorticoïden 2 weken voorafgaand aan screening
    - gebruik van cytostatica of immuun modulerende middelen
    - geschiedenis van allergie of overgevoeligheidsreactie voor exenatide of andere GLP-1 RA
    - gelijktijdige deelname in andere studie
    - medicatiegebruik, in de 30 dagen voorafgaand aan de studie, van een middel dat nog niet geregistreerd is
    - Personen die werkzaam zijn op de onderzoeksafdeling, direct betrokken bij de studie, of familie (partner, ouder kind, broer of zus, of biologisch of wettelijk vastgestelde) van personeel op de onderzoeksafdeling
    - personen die eerder hebben afgemaakt of zich hebben terug getrokken van
    deze of elke andere studie die GLP-1 RA of dipeptidyl peptidase (DDP-4) onderzochten binnen de afgelopen 6 maanden
    - linkshandigheid
    - visuele beperking welke niet te corrigeren is met een bril of contact lenzen
    - Personen die volgens de mening van de onderzoeker op een andere manier niet geschikt zijn om deel te nemen in de studie
    - slecht begrip van de Nederlandse taal of elke (mentale) stoornis waardoor volledig begrip van het onderzoek, instructie en daardoor participatie niet mogelijk is.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in neuronal activity in central reward and satiety circuits in response to food related stimuli by BOLD fMRI signal change from baseline compared to 16 weeks of treatment
    Verschillen in neuronale activiteit in CNS centrale belonings- en verzadigings circuits als reactie op voedsel gerelateerde stimuli door BOLD fMRI signaal verandering ten opzichte van de baseline en 16 weken behandeling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    fMRI are assessed at baseline, after 10 days en 16 weeks of treatment.
    E.5.2Secondary end point(s)
    • Differences in neuronal activity in the central reward and satiety circuits in response food related stimuli by BOLD fMRI signal compared to baseline and 1.5 weeks of treatment and 1.5 and 16 weeks of treatment between the exenatide+dapagliflozine, exenatide + placebo, dapagliflozin+placebo and double placebo groups
    • feeding behaviour, measured by quantitative and qualitative changes in food choice, during an ad libitum lunch buffet compared between the groups ( at baseline and 1,5 week , baseline and 16 weeks and 1.5 and 16weeks)
    • difference in self reported hunger, satiety and fullness by visual analogue scale
    •difference in resting energy expenditure measured by indirect calorimetry measurements between the groups (at baseline and 1,5 week , baseline and 16 weeks and 1.5 and 16weeks)
    • Change in bodyweight (kg) and body mass index (kg/m2) between the groups (at baseline and 1,5 week , baseline and 16 weeks and 1.5 and 16weeks)
    • Difference in bodycomposition measured by bio electrical impedance analysis and other body measurments such as waist and hip circumference between the 4 groups (at baseline and 1,5 week , baseline and 16 weeks and 1.5 and 16weeks)
    •difference in resting brain activity by fMRI; resting state measurements
    • effect on cardiovasculair autonomic balance by cardiovasculair reflex tests (bloodpressure, hartfrequency, ECG; assessed by finger plethysmography [NexFin])
    • renal measurements by single spot and 24 urine collection; cumulative glucose excretion (0-1,5, 0-16, 1,5-16 ), creatinine clearance (0-1,5, 0-16, 1,5-16 weeks ), tubulair function ; sodium excretion and urinary pH ((0-1,5, 0-16, 1,5-16 weeks), renal damage markers albumin/creatinin ratio (0-1,5, 0-16, 1,5-16weeks )
    • resting blood pressure
    • Change in the plasma/serum biomarkers of metabolism, liver function, estimated renal function (eGFR), electrolytes and haematocrit (0-1,5, 0-8, 0-16, 1,5-16 weeks)

    The following safety variables will be collected during the study:
    • Occurrence of adverse events (as reported by the patient)
    • Vital signs (pulse rate, blood pressure, body temperature)
    • Different end-point assessments that also serve as safety measurements: glucose, HbA1c, cholesterol, LDL and HDL cholesterol, sodium, creatinine, Ht, electrocardiograms.

    We will then measure the following exploratory endpoints.
    • Blood will be collected to have the opportunity to perform measurements of hormones, such as leptin, cortisol and ghrelin.

    • A blood sample will be collected for the study of genetic variation, for example. FTO gene variant


    • Verschillen in neuronale activiteit in CNS centrale belonings- en verzadigings circuits als reactie op voedsel gerelateerde stimuli door BOLD fMRI signaal verandering ten opzichte van de baseline in reactie op voedsel gerelateerde stimuli na 16 10 dagen behandeling tussen de exenatide+dapagliflozine, exenatide + placebo, dapagliflozine +placebo en dubbel placebo groepen
    • voedingsgedrag, gemeten door kwantitatieve en kwalitatieve veranderingen in voedsel keuze gedurende een keuze-lunch buffet zal worden vergeleken tussen de verschillende groepen ( baseline en 1,5 week, baseline en 16 weken, 1,5 week en 16 weken)
    • zelf geraporteerde honger, verzadiging en volheid door middel van visuele analoge sschalen (VAS)
    • verandering in lichaamsgewicht (kg) en Body mass index( kg/m2) tussen de vier groepen (baseline en week 16, baseline en 1,5 week en tussen 1,5 en 16 weken)
    • verschil in energieverbruik, gemeten door middel van indirecte calorimetrie meting tussen de vier groepen (baseline en week 16, baseline en 1,5 week en tussen 1,5 en 16 weken)
    • verschil in lichaamssamenstelling zal worden gemeten door middel van bio elektrische impedantie en andere lichaamsmetingen zoals middel-en heup omtrek vergeleken tussen de 4 groepen (baseline en week 16, baseline en 1,5 week en tussen 1,5 en 16 weken)
    • het verschil in hersenactiviteit in rust gemeten door middel van fMRI: resting state metingen
    • effect op cardiovasculaire autonome balans door middel van cardiovasculaire reflex testen (Bloeddruk, hartfrequentie, ECG)
    • bloeddruk in rust
    • renale metingen door middel van portie en 24 uurs urine; oa glucose excretie (tussen 0-1,5, 0-16, 1,5-16 weken) , creatinineklaring (tussen 0-1,5, 0-16, 1,5-16 weken) tubulaire functie; Na excretie en urine pH (tussen 0-1,5, 0-16, 1,5-16 weken) renale schade markers; alb/creatinine ratio (tussen 0-1,5 week en 0-16 weken)
    • verandering in plasma/serum biomarkers (metabolisme, leverfunctie, geschatte nierfunctie, elektrolyten, hematocriet) tussen 0-1,5, 0-8, 0-16, 1,5-16 weken

    Er zal naar de volgende veiligheidsvariabelen worden gekeken:
    • Door de patiënt zelf gerapporteerde bijwerkingen, vanaf informed consent tot 30 dagen na laatste dosis studiemedicatie
    • Vitale gegevens
    • laboratorium uitslagen oa. glucose, HbA1c, cholesterol, LDL, HDL, Natrium, creatinine, Hematocriet
    • Ecg's

    Exploratief:
    • bloedonderzoek op mogelijke verandering in hormonen zoals oa. leptine, cortisol en ghreline.
    • Mogelijk in de toekomst effecten van genetische variatie
    E.5.2.1Timepoint(s) of evaluation of this end point
    cardiovasculair autonomic nervous function test, BMI, bio-electrical impedance analysis, resting energy expenditure and 24h urine collection will be done at baseline after 10 days, and after 16 weeks of treatment.

    Safety
    Collection of adverse event information will begin at the signing of the informed consent and continues through 30 days after administration of the last dose of study medication.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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
    Mechanistic study adressing the mechanism of action of the GLP-1 receptor agonist exenatide and de SGLT-2 inhibitor dapagliflozin on the central nervous system
    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 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 Yes
    E.8.2.3.1Comparator description
    Combination therapy will also be compared with the monotherapy groups of the medicinal products
    E.8.2.4Number of treatment arms in the trial4
    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 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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state64
    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 different treatment is expected after completion of the study. Participants will return to their own physician.
    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 Decision2017-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-03
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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