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    The EU Clinical Trials Register currently displays   36827   clinical trials with a EudraCT protocol, of which   6080   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-011231-12
    Sponsor's Protocol Code Number:EFC11202
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-011231-12
    A.3Full title of the trial
    Estudio multinacional, de grupos paralelos, abierto, aleatorizado, de 24 semanas que compara Lantus® (insulina glargina) administrada por la mañana como insulina basal una vez al día con insulina NPH (Neutral Protamine Hagedorn), en niños con diabetes mellitus tipo 1 entre 1 y menos de 6 años de edad.
    __________________________________________________

    A 24-week, randomized, open-label, parallel group multinational comparison of Lantus® (insulin glargine) given in the morning as once-a-day basal insulin versus Neutral Protamine Hagedorn (NPH) insulin, in children with type 1 diabetes mellitus aged at least 1 year to less than 6 years
    A.3.2Name or abbreviated title of the trial where available
    PRESCHOOL (PRESchool CHildren with type 1 diabetes On mOrning Lantus)
    A.4.1Sponsor's protocol code numberEFC11202
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorsanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 LANTUS 100 Unidades/ml solución inyectable en un vial
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS DEUTSCHLAND GMBH
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNINSULINA GLARGINA
    D.3.9.1CAS number 160337-95-1
    D.3.9.3Other descriptive nameINSULIN GLARGINE
    D.3.10 Strength
    D.3.10.1Concentration unit EID50/dose 50% Embryo Infective Dose/dose
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 HUMULINA REGULAR 100 UI/ML solución inyectable en viales
    D.2.1.1.2Name of the Marketing Authorisation holderLILLY, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNINSULINA SOLUBLE NEUTRA HUMANA PRB
    D.3.9.3Other descriptive nameINSULINA SOLUBLE NEUTRA HUMANA PRB
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Pacientes con diabetes mellitus tipo 1, entre 1 y 6 años

    _______________________________________________

    Patients with type 1 diabetes mellitus, aged at least 1 year to less than 6 years
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10012609
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    EL objetivo principal del estudio es comparar la tasa de "todas las hipoglucemias" entre los niños tratados con insulina glargina y insulina NPH.
    __________________________________________________

    The primary study objective is to compare the rate of "all hypoglycemia" between children treated with insulin glargine and NPH insulin.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son comparar la insulina glargina y la insulina NPH en términos de:
    - Índices de los tipos específicos de hipoglucemias: sintomática, severa, nocturna, nocturna sintomática, y severa nocturna y sintomática.
    - Cambio en HbA1c desde la basal hasta la finalización del tratamiento, y HbA1c al final del tratamiento.
    - Porcentaje de pacientes que alcancen HbA1 menor que el 7.5% (valor diana) al finalizar el tratamiento.
    - Media de glucosa en sangre durante el ensayo y hasta el fin del tratamiento, monitorizado con CGMS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pacientes pediátricos con diabetes mellitus de tipo 1 de al menos 1 año de edad y menores de 6 años, de cuyos padres o tutores se habrá obtenido el consentimiento informado por escrito para participar en el estudio.
    ___________________________________________
    Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study.
    E.4Principal exclusion criteria
    1. Diagnóstico de diabetes de tipo 1 durante menos de 1 año
    2. HbA1c en el momento de la selección > 12% o < 6%
    3. Diabetes distinta de la diabetes de tipo 1.
    4. Los padres y pacientes no están dispuestos a efectuar todas las evaluaciones y tratamientos del estudio, incluida la monitorización de la glucemia en el domicilio, la inserción y mantenimiento del sensor CGMS en el centro y en el domicilio, inyecciones de insulina varias veces al día y las visitas al centro que se indique en el protocolo (si no se dispone de un teléfono, los pacientes pueden acudir a las visitas en persona).
    5. Pacientes y familias en los que no se puedan obtener 6 días en total (no necesariamente consecutivos) de datos útiles con el CGMS (ya sea mediante la sustitución del sensor en el domicilio o mediante la inserción del sensor en el centro en otra visita de selección, si fuera necesario) durante las evaluaciones de selección con el CGMS entre la Visita 2 y la visita de aleatorización
    6. Pacientes tratados con bomba de insulina durante los dos meses previos a la selección
    7. Antecedentes de trastorno convulsivo primario
    8. Antecedentes de episodios intensos de hipoglucemia acompañados de convulsiones y/o coma, o cetoacidosis diabética que cause la hospitalización o la asistencia en un servicio de urgencias, en los 2 meses previos a la visita de selección
    9. Desconocimiento de la hipoglucemia, determinada por el Investigador
    10. Creatinina sérica > 2,0 mg/dl en la selección
    11. ALT o AST séricas mayores de 3 veces el límite superior de la normalidad para la edad y sexo del paciente en el momento de la selección
    12. Hemoglobina < 10 g/dl, o recuento de plaquetas menor de 100 000/mm3 en la selección
    13. Tratamiento con cualquier fármaco hipoglucemiante oral en cualquier momento desde el diagnóstico de la diabetes
    14. Tratamiento con cualquier medicamento hipoglucemiante distinto de la insulina (p. ej., Symlin®) durante los 3 meses previos a la selección
    15. Tratamiento con glucocorticoides sistémicos en el mes previo a la selección.
    E.5 End points
    E.5.1Primary end point(s)
    Índice de acontecimientos de todas las hipoglucemias durante el tratamiento con los medicamentos de estudio, la cual consiste en:
    - Glucosa intersticial con CGMS < 70 mg/dl (3,9mM)
    - Valores de glucemia en sangre capilar del dedo < 70 mg/dl (3,9mM)
    - Episodios sintomáticos de hipoglucemia, validados por el centro según las anotaciones en los diarios de los pacientes
    ____________________________________________
    Event rate of "all hypoglycemia" during treatment with study drugs, which consists of: CGMS glucose <70 mg/dL (3.9mM) , Self-Monitored Blood Glucose values <70 mg/dL (3.9mM), symptomatic hypoglycemia episodes.
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) No
    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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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.1.1.1In 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) Yes
    F.1.1.5Children (2-11years) Yes
    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 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
    Young children (1 to less than 6 year-old)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 90
    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 Decision2009-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-30
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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