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    The EU Clinical Trials Register currently displays   42556   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-004221-28
    Sponsor's Protocol Code Number:P110104
    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:2011-12-22
    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 number2011-004221-28
    A.3Full title of the trial
    Comparaison Glibenclamide/Insuline dans le traitement du diabète gestationnel. Essai randomisé multicentrique de non infériorité
    A.3.2Name or abbreviated title of the trial where available
    INDAO
    A.4.1Sponsor's protocol code numberP110104
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 DAONIL 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDAONIL 5 mg
    D.3.4Pharmaceutical form Buccal tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNglibenclamide 5mg
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabète gestationnel
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10018209
    E.1.2Term Gestational diabetes
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Tester que le glibenclamide per os est non inférieur à l'insuline sous cutanée pour la survenue de complications périnatales dans la prise en charge des femmes enceintes développant un diabète gestationnel nécessitant un traitement autre que le régime diététique.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Les patientes éligibles sont
    -Femmes enceintes
    -18 à 45 ans
    -Diagnostic de diabète gestationnel entre 24 et 34 SA diagnostiqué soit
    -après une hyperglycémie par voie orale à 75 g
    Glycémie à jeun 0,92g/l (5,1 mmol/l) et < 1,26g/l (7mmol/l) et/ou une glycémie à 1h et 2h après 75g de glucose 1,80 g/l (10mmol/l) et 1,53g/l (8,5mmol/l) respectivement, soit
    -après charge 50g de glucose
    avec une glycémie à 1heure >1,30g/l (7,2 mmol/l) suivie d'une hyperglycémie par voie orale à 100g avec glycémie à jeun>0.95g/l (5,1 mmol/l) et < 1,26g/l (7mmol/l) et/ou glycémie à 1h, 2h et 3 heures > 1.8g/l (10mmol/l) ,1.55g/l (8,6 mmol/l) et 1.40g/l (7,8mmol/l) respectivement (2 valeurs pathologiques).
    -Prise en charge diététique complète de 10 jours : traitement par un régime adapté selon le besoin individuel des femmes, évalué lors d'une consultation diététique. Ce régime consistera en un apport de 35kcal/kg pour les patientes non obèses, réparti en 3 repas et 2 collations avec environ 40 à 45% des calories apportées par les hydrates de carbone, 20% par les protéines et 30-40% par les lipides. Cet apport sera de 25 Kcal/kg chez les patientes obèses définies par un IMC > 30 kg/m2. Ce régime sera associé à une incitation à l'activité sportive équivalente à 30mn de marche 3 à 5 fois par semaine si l'état obstétrical le permet. Les patientes recevront une éducation concernant l'utilisation des glucomètres pour l'autosurveillance glycémique. Ces appareils devront comporter des mémoires consultables et seront à la norme en ISO 15197.
    Pendant la période de régime, la surveillance sera établie en fonction des centres : auto surveillance des glycémies capillaires (4/jour), ou une glycémie à jeun et 2h après le repas au bout de 10 jours.
    Les patientes incluses sont
    -Patientes éligibles avec objectifs glycémiques non atteints c'est-à-dire celles pour lesquelles au moins deux valeurs anormales glycémies ont été relevée après 10 jours de prise en charge diététique bien menée: glycémie à jeun 0,95g/dl et/ou glycémie post prandiale à 2h 1,20g au cours de deux repas pris au même moment de la journée (2 petits-déjeuners, 2 déjeuners ou 2 dîners).
    E.4Principal exclusion criteria
    Critères de non-inclusion des personnes qui se prêtent à la recherche
    -Grossesse multiple
    -Hypertension artérielle chronique
    -Prééclampsie
    -Insuffisance rénale avérée
    -Insuffisance hépatocellulaire avérée
    -Patientes traitées par des corticoïdes au long cours
    -Notion d'allergie aux sulfamides
    -Diabète préexistant à la grossesse
    -Résultat anormal sur test de dépistage du diabète gestationnel avant 24SA
    -Glycémie à jeun 1,26g/l lors du diagnostic initial de diabète
    -Nécessité de traitement par un médicament contrindiqué ou déconseillé avec la prise de Glibenclamide
    -Mauvaise compréhension de la langue française
    -Absence de prise en charge sociale
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal de jugement est un critère composite regroupant les complications néonatales associées au diabète gestationnel. Chaque composant reflète les effets indésirables potentiels de l'exposition à l'hyperglycémie maternelle et par conséquent de l'hyperinsulinisme foetal. Les composants retenus pour ce critère composite sont :
    -la macrosomie foetale ou le poids de naissance > 90ème percentile pour l'âge gestationnel,
    -l'hypoglycémie néonatale
    -l'hyperbilirubinémie néonatale.
    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 Yes
    E.6.13.1Other scope of the trial description
    Essai de non infériorité
    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) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned27
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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 Yes
    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) Yes
    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) No
    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 No
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    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 state900
    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 Decision2012-01-19
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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