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    Summary
    EudraCT Number:2011-003221-97
    Sponsor's Protocol Code Number:FSJD-HIPERGLU-2011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-08-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-003221-97
    A.3Full title of the trial
    BENEFICIOS DEL CONTROL GLICÉMICO ESTRICTO SOBRE EL PRONÓSTICO DEL PACIENTE PEDIÁTRICO CRÍTICAMENTE ENFERMO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Beneficios del tratamiento intensivo con insulina de las subidas de azúcar asociadas a las enfermedades graves (de UCIP) de los niños
    A.3.2Name or abbreviated title of the trial where available
    FSJD-HIPERGLU-2011
    A.4.1Sponsor's protocol code numberFSJD-HIPERGLU-2011
    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 SponsorFundacio Sant Joan de Deu
    B.1.3.4CountrySpain
    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 supportFundacio Sant Joan de Deu
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundacio Sant Joan de Deu
    B.5.2Functional name of contact pointRosa Morales Palau
    B.5.3 Address:
    B.5.3.1Street AddressSanta Rosa 39-57 3ª Planta
    B.5.3.2Town/ cityEsplugues de Llobregat (Barcelona)
    B.5.3.3Post code08950
    B.5.3.4CountrySpain
    B.5.4Telephone number+349360097514394
    B.5.5Fax number+34936009771
    B.5.6E-mailrmorales@fsjd.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 ACTRAPID HM
    D.2.1.1.2Name of the Marketing Authorisation holderNovo-Nordisk
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameActrapid HM
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.2Current sponsor codeA10AB 01
    D.3.9.3Other descriptive nameRAPID-ACTING INSULIN
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.3.5.1CAT classification and reference number11061-68-0
    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
    Nuestra hipotesis es que el tratamiento intensivo con insulina endovenosa de la hiperglucemia asociada a las patologías críticas del paciente pediátrico mejora el pronóstico de las mismas
    E.1.1.1Medical condition in easily understood language
    El tratamiento intensivo de las subidas de azúcar con insulina en niños que están graves mejora su pronóstico
    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
    1.Determinar la influencia de los niveles de hiperglucemia sobre el pronóstico del paciente pediátrico críticamente enfermo
    2.Evaluar los posibles beneficios de la terapia insulínica intensiva en términos de morbilidad y mortalidad
    E.2.2Secondary objectives of the trial
    1.Analizar los posibles factores causales de la hiperglucemia en el paciente pediátrico con patología crítica.
    2.Valorar si existen cambios en los requerimientos de ventilación mecánica y los días de estancia de los pacientes hiperglucémicos tratados con insulinoterapia intensiva.
    3.Investigar la influencia del tratamiento insulínico en los pacientes hiperglucémicos sobre la incidencia de sepsis secundaria.
    4.Determinar la incidencia de hipoglucemia asociada a la terapia intensiva con insulina.
    5.Documentar el número de hipoglucemias que se producen tras el empleo de insulina en estos pacientes y valorar los posibles efectos de la misma sobre la morbilidad y la mortalidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Pacientes con estancia en la Unidad de Cuidados Intensivos durante un periodo superior a 36 horas
    2)Sujetos con edad igual o superior a 30 días de vida, hasta los 18 años de edad
    3)Pacientes que no cumplan criterios de exclusión
    E.4Principal exclusion criteria
    1)Negativa a firmar el consentimiento informado
    2)Pacientes con estancia en UCIP inferior a 36 horas
    3)Pacientes con limitación del esfuerzo terapéutico (paliativos) en el momento del ingreso en UCIP
    4)Pacientes con edad en periodo neonatal (< 30 días de vida)
    5)Debut de Diabetes Mellitus o diagnosticada previamente
    6)Intolerancia a la glucosa o cualquier enfermedad que predispongan a una alteración del metabolismo de la glucosa
    7)Antecedentes de episodios graves de hipoglucemias.- Se catalogará de hipoglucemia grave a todo episodio con glucemia < 50 mg/dl asociado a pérdida de conocimiento con o sin convulsiones y de hipoglucemia moderada la presencia de un nivel glucémico < 40 mg/dl exista o no sintomatología
    8)Alergias medicamentosas al producto del ensayo
    E.5 End points
    E.5.1Primary end point(s)
    Variable principal: Como variable principal a lo largo del periodo de estudio se valorarán los niveles glucémicos registrados durante todo el ingreso en ambos grupos, antes del inicio del tratamiento insulínico y durante el mismo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Finalización de la estancia de cada sujeto en la Unidad de Cuidados Intensivos Pediátricos
    E.5.2Secondary end point(s)
    Variable secundaria: Se valorarán los datos del tratamiento de ambos grupos de pacientes, tales como tiempo de perfusión de insulina, tiempo en intervalo libre de tratamiento, necesidad de reintroducción de la insulinoterapia en un mismo paciente y episodios de hipoglucemia asociados al tratamiento. Se evaluará el uso de fármacos hiperglucemiantes como los corticoides, la necesidad de inotrópicos y duración de administración, necesidad de ventilación mecánica y duración de la misma, presentación de sepsis secundaria durate el ingreso en UCIP y duración de la estancia tanto en UCIP como en hospitalización en planta de pediatría
    E.5.2.1Timepoint(s) of evaluation of this end point
    Finalización de la estancia de cada sujeto en la Unidad de Cuidados Intensivos Pediátricos
    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) 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Secuencial
    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
    Mismo fármaco pero utilizado con otro criterio de inicio (otro nivel de glucemia)
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 204
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 60
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 74
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 70
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Población pediátrica. Dará el consentimiento informado su representante legal
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state204
    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 se realizarán controles ni seguimientos a los sujetos que ya no estén ingresados en la UCI-P.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-01
    P. End of Trial
    P.End of Trial StatusOngoing
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