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    Summary
    EudraCT Number:2018-002162-38
    Sponsor's Protocol Code Number:PSS2018/REALIST-GUERCI/AS
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-09
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-002162-38
    A.3Full title of the trial
    Researching an Effect of GLP-1 Agonist on liver STeatosis (REALIST).
    A Multicentre controlled and randomized Study assessing the effect of Dulaglutide (TRULICITY®) add-on to dietary reinforcement versus dietary reinforcement alone in patients with type 2 diabetes and carriers of a non-alcoholic steatohepatitis.
    Recherche d’Effet d’un Analogue du récepteur au GLP1 sur la STéatose hépatique - REALIST (Researching an Effect of GLP-1 Agonist on liver STeatosis)
    Une étude multicentrique contrôlée et randomisée évaluant l'effet du Dulaglutide (TRULICITY®) en plus du renforcement diététique versus le renforcement diététique seul chez des patients diabétiques de type 2 et porteurs d'une stéatohépatite non alcoolique (NASH).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the effect of Dulaglutide (TRULICITY®) add-on to dietary reinforcement versus dietary reinforcement alone in patients with type 2 diabetes and carriers of a non-alcoholic steatohepatitis
    Une étude comparant l'effet du Dulaglutide (TRULICITY®) en plus du renforcement diététique versus le renforcement diététique seul chez des patients diabétiques de type 2 et porteurs d'une stéatohépatite non alcoolique (NASH).
    A.3.2Name or abbreviated title of the trial where available
    REALIST
    REALIST
    A.4.1Sponsor's protocol code numberPSS2018/REALIST-GUERCI/AS
    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 SponsorCHRU de Nancy
    B.1.3.4CountryFrance
    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 supportLILLY France
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Nancy
    B.5.2Functional name of contact pointAmandine SEIWERT, chef de projets
    B.5.3 Address:
    B.5.3.1Street AddressDirection de la Recherche et de l'Innovation - Bâtiment Recherche - rue du Morvan
    B.5.3.2Town/ cityVANDOEUVRE LES NANCY
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.4Telephone number0033383153563
    B.5.5Fax number0033383157451
    B.5.6E-maildripromoteur@chru-nancy.fr
    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 TRULICITY
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten, Pays-Bas.
    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.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNDULAGLUTIDE
    D.3.9.1CAS number 923950-08-7
    D.3.9.2Current sponsor codeDULAGLUTIDE
    D.3.9.3Other descriptive nameDULAGLUTIDE
    D.3.9.4EV Substance CodeSUB130484
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 and carriers of a non-alcoholic steatohepatitis (NASH).
    Patients diabétiques de type 2 atteints d'une stéatohépatite non alcoolique (NASH).
    E.1.1.1Medical condition in easily understood language
    Patients with type 2 diabetes and carriers of a non-alcoholic steatohepatitis (NASH).
    Patients diabétiques de type 2 atteints d'une stéatohépatite non alcoolique (NASH).
    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
    The primary objective of this study is to assess the effect of dulaglutide (TRULICITY®) add- on to dietary reinforcement after 52 weeks of treatment, on the improvement of liver histology compared to dietary reinforcement alone in patients with type 2 diabetes and carriers of non-alcoholic steatohepatitis.
    L’objectif principal de cette étude est d’évaluer l’effet du traitement par dulaglutide (TRULICITY®) en plus du renforcement diététique après 52 semaines de traitement, sur l'histologie hépatique comparativement au renforcement diététique seul chez des patients diabétiques de type 2 atteints d'une stéatohépatite non alcoolique (NASH).
    E.2.2Secondary objectives of the trial
    - After 52 weeks of treatment, to assess the effect of dulaglutide (TRULICITY®) add-on to dietary reinforcement on Fibrosis score, Transaminase levels, body composition as measured by dual energy X-ray absorptiometry, lipid profile and glycemic control. The effect of the treatment will also be assessed on quality of life.

    - At 24 weeks after completion of the treatment, to assess the sustainability of dulaglutide (TRULICITY®) treatment add-on to dietary reinforcement on ALT and AST rates as well as on weight.
    - Après 52 semaines de traitement, évaluer l'effet du dulaglutide (TRULICITY®) en plus du renforcement diététique sur les scores de fibrose, le taux des transaminases, la composition corporelle mesurée par absorption bi photonique à rayons X (DEXA), le profil lipidique et le contrôle glycémique. L'effet du traitement sera également évalué sur la qualité de vie.

    - À 24 semaines après la fin du traitement, évaluer la durabilité du traitement par Dulaglutide (TRULICITY®) en plus du renforcement diététique, sur les taux d'ALAT et d'ASAT ainsi que sur le poids.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At baseline:
    • Age > 18 years, < 75 years
    • Patients with moderately controlled type 2 diabetes under oral antidiabetic drugs (OADs) except DPP-4 inhibitors at a stable dose since at least 3 months. Standard basal insulin treatments for at least 6 months before inclusion are allowed in addition to OADs.
    • 7.0%≤HbA1c≤ 9.0% confirmed in two assays over the last six months
    • 25 <BMI <40 kg/m2
    • Patients carriers of confirmed stable non-alcoholic steatohepatitis diagnosed by liver biopsy dating less than six months, with a Kleiner score ≥ 3 and 1 or more points in the hepatocellular ballooning score
    • Stable weight during the six months prior to inclusion, i.e. the change in weight must not exceed 5% in the last six months since the last liver puncture biopsy (LPB).
    • Person volunteered to participate in the study, informed about study organization and having signed the consent form
    • Person affiliated to or beneficiary of a social security plan
    • Person undergone the medical examination adapted to research

    At randomization:
    • The diagnosis and the stage of non-alcoholic steatohepatitis must be confirmed after centralized reading of the hepatic histology of the liver puncture biopsy (LPB) performed within six months prior to inclusion, by a pathologist designated for the study.
    A l’inclusion :
    • Age > à 18 ans, < à 75 ans
    • Patients diabétiques de type 2 modérément équilibrés sous traitement antidiabétique oral (ADO), à l’exception des inhibiteurs de DPP-4, à une dose stable depuis au moins 3 mois. Les traitements standards par insuline basale pendant au moins 6 mois avant l'inclusion sont autorisés en plus des ADO.
    • 7.0%≤HbA1c≤ 9.0% confirmée sur deux dosages sur les six derniers mois
    • 25 <IMC<40 kg/m2
    • Patients porteurs d’une stéatohépatite non alcoolique stable confirmée et diagnostiquée par biopsie hépatique datant de moins de 6 mois, avec un score de Kleiner ≥ 3 points et avec au moins 1 point de ballonisation
    • Poids stable durant les six mois précédant l’inclusion c’est à dire la variation du poids ne doit pas dépasser 5% durant les six derniers mois depuis la dernière PBH
    • Personne volontaire pour participer à l’étude, ayant reçu l’information complète sur l’organisation de la recherche et ayant signé son consentement éclairé
    • Personne affiliée à un régime de sécurité sociale ou bénéficiaire d’un tel régime
    • Personne ayant réalisé un examen clinique préalable adapté à la recherche

    A la randomisation :
    Le diagnostic ainsi que le stade de la stéatohépatite non alcoolique doivent être confirmés après relecture centralisée de l’histologie hépatique de la PBH réalisée dans les six mois avant l’inclusion, par un anatomopathologiste désigné pour l’étude du centre coordonnateur.
    E.4Principal exclusion criteria
    • Patients who received a treatment with a GLP-1 agonist, DPP-4 inhibitors, SGLT2 inhibitors, Thiazolidinediones (TZDs), hepatoprotective drugs such as silymarine (Legalon®) or Ursodeoxycholic acid (Cholurso®, Delursan®, Ursolvan®), vitamin E or Betaine during the six months prior to inclusion (3 months before the reference biopsy)
    • Patients receiving rapid insulin (human insulin, rapid insulin analogues or premix) in the last 6 months before screening visit
    • Type 1 Diabetes
    • Patients with idiopathic hemochromatosis
    • Patients carriers of hepatitis B or C
    • Severe or terminal renal impairment (calculated clearance < 30 ml/min according to the MDRD formula)
    • Class III or IV congestive heart failure according to the NYHA classification
    • Chronic alcoholism. The investigator while interviewing the patient at the baseline visit assesses alcohol consumption. This consumption must be limited to 30g/day of alcohol for men and 20g/day of alcohol for women
    • Hepatic fibrosis with a Metavir score ≥ F3 (for a score = F3, patients with a platelet count > 120,000 and an albumin concentration > 35 g/l can be included) or gastrointestinal bleeding
    • History of acute or chronic pancreatitis
    • Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC), or personal history of non-familial medullary thyroid carcinoma
    • Patients who had bariatric surgery
    • Patients who received drug treatment for obesity, notably Orlistat, during the last 6 months
    • Patients with a known allergy or hypersensitivity to the study product or one of its excipients
    • Any other condition deemed incompatible with the proper conduct of the study as determined by the investigator
    • Patient having participated in another biomedical research with the taking of an experimental drug within 3 months prior to the screening visit or subject under an exclusion period for other biomedical research.
    • Woman of childbearing age without effective contraception
    • Person referred in articles L.1121-5, L.1121-7 and L.1121-8 of the Public Health Code:
    - Pregnant, parturient or breastfeeding woman
    - Minor person (non-emancipated)
    - Adult person under legal protection (any form of public guardianship)
    - Adult person incapable of giving consent
    • Person deprived of liberty for judicial or administrative decision, Person under psychiatric care according to articles L. 3212-1 and L. 3213-1.
    • Patients ayant reçu un traitement par un agoniste au GLP-1, des inhibiteurs de la DPP-4, des inhibiteurs des SGLT2, des thiazolidinediones (TZD), des médicaments hépatoprotecteurs tels que la silymarine (Legalon®) ou l'acide ursodésoxycholique (Cholurso®, Delursan®, Ursolvan®), la vitamine E ou la bétaïne pendant les six mois précédant l'inclusion (3 mois avant la biopsie de référence)
    • Patients recevant un traitement par insuline rapide (insuline humaine, analogues de l'insuline rapide ou pré-mix) au cours des 6 derniers mois avant la visite d’inclusion
    • Diabète de type 1
    • Patients atteints d'hémochromatose idiopathique
    • Patients porteurs de l'hépatite B ou C
    • Insuffisance rénale sévère ou terminale (clairance calculée <30 ml / min selon la formule MDRD)
    • Insuffisance cardiaque congestive de classe III ou IV selon la classification de la NYHA
    • L'alcoolisme chronique. L'investigateur interroge le patient lors de la visite d’inclusion et évalue la consommation d'alcool du patient. Cette consommation doit être limitée à 30g / jour d'alcool pour les hommes et 20g / jour d'alcool pour les femmes
    • Fibrose hépatique avec un score de Metavir ≥ F3 (pour un score = F3, les patients avec une numération plaquettaire > 120 000 et une concentration d'albumine > 35 g / l peuvent être inclus) ou des saignements gastro-intestinaux
    • Antécédents de pancréatite aiguë ou chronique
    • Antécédents personnels ou familiaux de néoplasie endocrinienne multiple de type 2 (MEN2) ou de carcinome médullaire de la thyroïde familiale (FMTC), ou antécédents personnels de carcinome médullaire de la thyroïde non familial
    • Patients ayant subi une chirurgie bariatrique
    • Patients ayant reçu un traitement médicamenteux contre l'obésité, notamment l'Orlistat, au cours des 6 derniers mois
    • Patients présentant une allergie ou une hypersensibilité connue au produit étudié ou à l'un de ses excipients
    • Toute autre condition jugée incompatible avec la bonne conduite de l'étude telle que déterminée par l'investigateur
    • Patient ayant participé à une autre recherche biomédicale avec prise d'un médicament expérimental dans les 3 mois précédant la visite d’inclusion ou soumis à une période d'exclusion pour d'autres recherches interventionnelles
    • Femme en âge de procréer ne disposant pas de moyen de contraception efficace
    • Personnes visées aux articles L.1121-5, L.1121-7 et L.1121-8 du code de la santé publique:
    - Femme enceinte, parturiente ou allaitante
    - Personne mineure (non émancipée)
    - Personne majeure faisant l'objet d'une mesure de protection légale (tutelle, curatelle, sauvegarde de justice)
    - Personne majeure hors d’état d’exprimer son consentement
    • Les personnes privées de liberté par une décision judiciaire ou administrative, les personnes faisant l’objet de soins psychiatriques en vertu des articles L. 3212-1 et L. 3213-1.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the responder’s proportion difference between the two groups (dulaglutide (TRULICITY®) on top of dietary reinforcement vs. dietary reinforcement alone) after 52 weeks of treatment. A responder is defined as having a decrease of at least two points in the Kleiner score and no worsening of fibrosis on liver histology obtained by liver puncture biopsy.
    The histological NASH activity score or Kleiner score is measured on three components: steatosis, the necrotic -inflammatory foci and hepatocyte ballooning.
    Le critère d'évaluation principal de l'étude est la différence de proportion de répondeurs entre les deux groupes (dulaglutide (TRULICITY®) en plus du renforcement diététique vs renforcement diététique seul) après 52 semaines de traitement. Un répondeur est défini comme ayant une diminution d'au moins deux points dans le score de Kleiner et aucune aggravation de la fibrose sur l'histologie hépatique obtenue par ponction biopsie hépatique (PBH).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 52 weeks of treatment
    Après 52 semaines de traitement
    E.5.2Secondary end point(s)
    - After 52 weeks of treatment, to assess the effect of dulaglutide (TRULICITY®) add-on to dietary reinforcement on:
    1. Fibrosis scores:
    a. Mean Changes in Fibrosis METAVIR score with distribution of patients into 3 groups according to the evolution of the score: improvement, stability or worsening.
    b. Mean changes in Fibrotest measurement (six markers dosage: ALT, total bilirubin, GGT, Apolipoprotein A1, alpha 2-macroglobulin, haptoglobin)
    c. Serum hyaluronic acid
    2. Changes in serum levels of liver enzymes ALT and AST
    3. Changes in Lipid parameters:
    a. LDL-cholesterol rate
    b. HDL-cholesterol rate
    c. Triglycerides rate
    4. Improvement of the glycemic control
    a. Fasting glucose
    b. HbA1c
    5. Change in body composition assessed by dual-energy x-ray absorptiometry scans.
    6. Change in quality of life (Quality of Life, Obesity and Diet Scale - QUOLOD questionnaire)

    - At 24 weeks after completion of the treatment, assess the sustainability of dulaglutide (TRULICITY®) treatment on ALT and AST rates as well as on weight.
    - Après 52 semaines de traitement, évaluer l'effet du Dulaglutide (TRULICITY®) en plus du renforcement diététique sur:
    1. Scores de la fibrose:
    a. Changement du score histologique de la fibrose (METAVIR) avec répartition des patients en 3 groupes en fonction de l'évolution du score: amélioration, stabilité ou aggravation.
    b. Changement du score de fibrose : Fibrotest (dosage de six marqueurs: ALAT, bilirubine totale, GGT, Apolipoprotéine A1, alpha 2-macroglobuline, haptoglobine)
    c. Taux sérique de l’acide hyaluronique
    2. Changement des taux sériques d'enzymes hépatiques ALAT et ASAT
    3. Changement des paramètres lipidiques :
    a. Taux de LDL-cholestérol
    b. Taux de HDL-cholestérol
    c. Taux de triglycérides
    4. Amélioration du contrôle glycémique :
    a. Glycémie à jeun
    b. HbA1C
    5. Modification de la composition corporelle mesurée par absorptiométrie à rayons X (DEXA)
    6. Modification de la qualité de vie (questionnaire Échelle Qualité de Vie, Obésité et Diététique- EQVOD)

    - À 24 semaines après la fin du traitement, évaluer la durabilité du traitement par dulaglutide (TRULICITY®) sur les taux d'ALAT et d'ASAT ainsi que sur le poids.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - After 52 weeks of treatment
    - At 24 weeks after completion of the treatment
    - Après 52 semaines de traitement
    - À 24 semaines après la fin du traitement
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    renforcement diététique
    dietary reinforcement
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state120
    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. The choice of treatment or care is left to the investigator's discretion.
    At the end of participation in the study, whether or not discontinuation is premature, patients will continue to be followed by their diabetologist and their hepatologist depending on the state of knowledge at the time.
    Aucun. Le choix du traitement ou de la prise en charge est laissé à la convenance de l'investigateur.
    À la fin de la participation à l'étude, en cas d'arrêt prématuré ou non, les patients continueront d'être suivis par leur diabétologue et leur hépatologue selon l'état des connaissances à ce moment.
    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 Decision2018-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
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