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    Summary
    EudraCT Number:2009-010707-92
    Sponsor's Protocol Code Number:HSJD-MET-DM1
    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:2009-03-11
    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 number2009-010707-92
    A.3Full title of the trial
    EMPLEO DE METFORMINA EN NIÑOS Y ADOLESCENTES CON DIABETES MELLITUS TIPO 1
    USE OF METFORMIN IN CHILDREN AND ADOLESCENTS WITH TYPE 1 DIABETES MELLITUS
    A.4.1Sponsor's protocol code numberHSJD-MET-DM1
    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 SponsorHOSPITAL SANT JOAN DE DÉU
    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 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 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 METFORMINA SANDOZ 850 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ FARMACEUTICA, S.A.
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETFORMINA
    D.3.9.1CAS number 657-24-9
    D.3.9.3Other descriptive nameMETFORMIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    DIABETES MELLITUS TIPO I EN PACIENTES PEDIATRICOS CON MAL CONTROL GLUCEMICO Y TRATAMIENTO CON DOSIS ALTAS DE INSULINA.

    TYPE I DIABETES MELLITUS IN PEDIATRIC PATIENTS WITH POORLY CONTROL AND TREATEMENT WITH HIGH DOSES OF INSULIN
    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.- Objetivos primarios:

    1.-Determinar si el empleo de metformina en niños y adolescentes con diabetes tipo 1 y altos requerimientos de insulina mejora el control metabólico.

    2.- Constatar si se produce una disminución en las dosis de insulina asociado al empleo de metformina.
    E.2.2Secondary objectives of the trial
    2.- Objetivos secundarios

    1.- Valorar si existen cambios en la composición corporal asociadas al uso de metformina.

    2.- Investigar si se produce mejoría del perfil lípídico tras el empleo de metformina.

    3.- Documentar el número de hipoglucemias que se producen tras el empleo de metformina en estos pacientes y valorar la seguridad del tratamiento adyuvante con metformina en niños y adolescentes con diabetes mellitus tipo 1.

    4.- Evaluar si los cambios que se producen a nivel de las proteinas del eje GH (hormona de crecimiento), IGF-1 e IGF-BP3 son válidos para evaluar la efectividad del tratamiento con metformina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pacientes de 9-18 años afectos de diabetes mellitus tipo 1 con niveles de HbA1c entre 8 -11%, cuyo seguimiento se realiza en la Unidad de Diabetes del Hospital San Juan de Dios de Barcelona y que presenten al inicio del estudio requerimientos de insulina : > 0,9 U/Kg/día en pacientes pre-puberales y > 1,1 U/kg/d en pacientes puberales y post-puberales.
    Es necesario la firma del consentimiento informado previo al inicio del estudio.
    E.4Principal exclusion criteria
    -Diabetes Mellitus tipo 2
    -Diabetes monogénica
    -Hepatopatía
    -Microalbuminuria persistente
    -Insuficiencia renal
    -Negativa a firmar el consentimiento informado
    -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 < 60 mg/dl exista o no sintomatología.
    -Antecedentes de cetoacidosis recurrentes
    -Mal cumplimiento de los tratamientos. Se considerará que existe mal cumplimiento terapéutico cuando una vez iniciado el estudio el paciente reconozca que ha omitido un 10% de las dosis de metformina o placebo o bien, cuando el paciente reconozca haber omitido más de 4 dosis de insulina.
    -HbA1c <8%
    -HbA1c >11%
    -Peso inferior al percentil 10 para su edad cronológica
    E.5 End points
    E.5.1Primary end point(s)
    a) Datos clínicos: talla, peso, IMC, número de controles al día (mínimo 4 al día), calorías ingeridas y raciones de carbohidratos de la dieta, y horas semanales de realización de ejercicio físico. Para la estimación de la cantidad de ejercicio se empleará el Baecke Questionnaire of Habitual Activity.
    b) Registro de glucemias capilares
    c) Valoración clínica y analítica de efectos secundarios: En este sentido, se medirán los posibles efectos secundarios que han sido descritos para la metformina: gastrointestinales (náusea, vómitos, dolor abdominal,?), acidosis láctica e hipoglucemias. Los pacientes deberán anotar en la libreta de control los episodios de hipoglucemia. 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 < 60 mg/dl exista o no sintomatología.
    d) Medición de pliegues corporales mediante medidor de pliegues cutáneos de Holtain. La determinación se realizará en las visitas de seguimiento por parte de pediatras endocrinólogos titulados. En ellas se medirá pliegue bicipital, pliegue tricipital, pliegue subescapular y pliegue iliaco, así como perímetro abdominal y perímetro del muslo. Las medidas se compararán con los estándares de Ferrández et al. Zaragoza, 2002.
    e) Nivel de HbA1c: para medir el nivel de HbA1c se utilizará el sistema DCA 2000 BAYER. El nivel de referencia para personas sanas es de 4-6 %.
    f) Niveles de lípidos: Se analizarán a partir de muestas sanguíneas obtenidas en ayunas usando método enzimático colorimétrico GPO/PAP Architect ci8200 (Abbott).
    g) Niveles de IGF-1 e IGFBP-3. El estudio de estas variables está justificado por que el eje GH-IGF-1 puede estar alterado en pacientes puberales con diabetes tipo 1. Los niveles elevados de GH yde los factores de crecimiento del periodo puberal favorece la insulinorresistencia al emperorar la sensibilidad periférica a la insulina. No hay estudios que valoren estos parámetros en pacientes pre-puberales.
    h) Estudio de composición corporal mediante densitometría. Los valores de referencia serán los realizados en población pediátrica en CETIR.
    i) Medición de grado de satisfacción del tratamiento y calidad de vida mediante la encuesta Diabetes Specific Quality of Life Scale (DSQOLS) y el cuestionario Diabetes Treatment Satisfaction Questionnaire (DTSQ).
    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 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) 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 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
    TRES MESES DESPUES DE QUE EL ULTIMO PACIENTE INCLUIDO EN EL ESTUDIO FINALICE EL TRATAMIENTO
    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 months0
    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) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-03-11. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    PACIENTES DE 9 A 17 AÑOS DE EDAD
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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 Decision2009-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
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