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    Summary
    EudraCT Number:2007-003579-38
    Sponsor's Protocol Code Number:APIDR_C_02083
    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:2010-03-09
    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 number2007-003579-38
    A.3Full title of the trial
    Efecto de la insulina glulisina en comparación con la insulina aspart y la insulina lispro cuando se administran mediante Infusión Subcutánea Continua de Insulina (ISCI) sobre parámetros específicos de la bomba en pacientes con Diabetes Mellitus de tipo 1
    A.3.2Name or abbreviated title of the trial where available
    Estudio de bombas
    A.4.1Sponsor's protocol code numberAPIDR_C_02083
    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 groupe
    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 Apidra®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    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.3.1Product nameInsulina glulisina
    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 glulisina
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml 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.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 NovoRapid®
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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.3.1Product nameInsulina aspart
    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 aspart
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml 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.IMP: 3
    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 Humalog®
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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.3.1Product nameInsulina lispro
    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 lispro
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml 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
    Diabetes Mellitus de tipo 1
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045228
    E.1.2Term Type I diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la superioridad de la insulina glulisina sobre la insulina aspart y la insulina lispro administradas mediante una bomba externa en cuanto a la hiperglucemia no explicada y/o la oclusión del equipo de infusión.
    A efectos del estudio, el equipo de infusión siempre se referirá al catéter y la cánula.
    E.2.2Secondary objectives of the trial
    comparar la insulina glulisina, la insulina aspart y la insulina lispro con respecto a:
    • Hiperglucemia no explicada.
    • Oclusión del equipo de infusión.
    • HbA1c, episodios de hipoglucemia, perfil de glucemia de 7 puntos, episodios de cetosis y de cetoacidosis.
    • Dosis de insulina (total, basal, bolo).
    • Tiempo hasta el cambio del equipo de infusión. El equipo de infusión y el depósito siempre se sustituirán al mismo tiempo, sea de forma sistemática o cuando se produzca o se sospeche una oclusión.
    • Infección,inflamación/eritema, prurito y dolor aislado en el punto de inyección.
    • Seguridad global: incidencia de acontecimientos adversos.
    • Cambio en el peso corporal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombres o mujeres de entre 18 y 75 años inclusive.
    2. Pacientes con diabetes de tipo 1.
    3. Tratados con insulina durante al menos 2 años y mediante ISCI durante al menos 6 meses.
    4. Que estén utilizando la misma insulina (insulina glulisina, insulina aspart o insulina lispro) en ISCI durante al menos 3 meses con la misma bomba externa compatible con los tres análogos de la insulina de acción rápida utilizados en el estudio.
    5. Que estén usando el mismo tipo de equipo de infusión (catéter y cánula) durante al menos 3 meses.
    6. Que se realicen un mínimo de 3 controles de glucemia al día.
    7. HbA1c < 8,5%.
    8. Índice de masa corporal (IMC) < 35 kg/m2.
    9. Capacidad y disposición para realizar controles de glucemia y cetonemia mediante el medidor combinado de glucosa y cetona y el diario del paciente en casa, ambos proporcionados por el promotor.
    10. Obtención del consentimiento informado por escrito antes del reclutamiento en el estudio.
    E.4Principal exclusion criteria
    1. Diabetes que no sea de tipo 1.
    2. Dosis diaria total de insulina mayor de 90 U/día.
    3. Uso de una bomba de insulina que requiera cartuchos precargados.
    4. Antecedentes de infección en el lugar de la infusión que requiera drenaje en los últimos 3 meses.
    5. Antecedentes de episodios graves de cetosis que requieran hospitalización.
    6. Retinopatía proliferativa activa, definida por la realización de fotocoagulación o vitrectomía en los 6 meses anteriores a la visita 1, o cualquier otra retinopatía inestable (en progresión rápida) que pueda requerir fotocoagulación o intervención quirúrgica durante el estudio. Se debe haber realizado una exploración oftalmoscópica en los 2 años anteriores a la entrada en el estudio.
    7. Embarazo (las mujeres en edad fértil deben presentar una prueba de embarazo negativa al entrar en el estudio y un método anticonceptivo autorizado médicamente) o lactancia.
    8. Tratamiento con corticoesteroides sistémicos o medicación que se sabe que influya en la sensibilidad a la insulina en los 3 meses anteriores a la visita 1.
    9. Tratamiento con antidiabéticos que no sean insulina en los 3 meses anteriores a la visita 1.
    10. Posibilidad de necesitar tratamientos durante el estudio que no estén permitidos.
    11. Tratamiento con un producto en investigación en los 30 días anteriores a la visita 1.
    12. Antecedentes de sensibilidad a los fármacos del estudio o a fármacos con estructura química similar.
    13. Presencia de algún problema (médico, alteraciones analíticas clínicamente significativas, psicológico, social o geográfico) real o esperado que el investigador considere que afectaría a la seguridad del paciente o limitaría el éxito de su participación en el estudio.
    14. Trabajadores de turnos de noche.
    15. Alteración de la función renal definida por una concentración de creatinina sérica ≥ 1,5 mg/dl (133 µmol/l) o ≥ 1,4 mg/dl (124 mol/l) en hombres y mujeres, respectivamente.
    16. Alteración de la función hepática, definida por un nivel de Alanina aminotransferasa (ALT) y Aspartato aminotransferasa (AST) tres veces mayor que el límite superior de la normalidad.
    17. Abuso de alcohol o drogas en el último año.
    18. Pacientes cuyo estado mental les incapacite para comprender la naturaleza, el objetivo y las posibles consecuencias del estudio.
    19. Pacientes cuyo cumplimiento del protocolo sea dudoso, p. ej., actitud no colaboradora, incapacidad para asistir a las visitas de seguimiento e improbabilidad de completar el estudio.
    20. El paciente es el investigador o un subinvestigador, un asistente de investigación, un coordinador del estudio u otro miembro del personal o familiar de los mismos relacionado de forma directa con la realización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Datos recogidos para la evaluación de los criterios principales de valoración y los criterios principales secundarios
    - Durante todo el estudio
    • Episodios de hiperglucemia no explicada, es decir glucosa plasmática (GP) por encima de 300 mg/dl (16,7 mmol/l) sin motivo médico o alimentario aparente, dosis de insulina insuficiente, o fallo de la bomba.
    • Episodios de oclusión del equipo de infusión. Los signos de oclusión pueden ser:
    o Alarma de oclusión de la bomba
    o Observación de oclusión por el paciente
    • Tiempo hasta el cambio del equipo de infusión y el depósito.
    • Absceso (infección local que requiera drenaje), infección en el lugar de infusión que requiera tratamiento antibiótico local o general, inflamación/eritema en el lugar de infusión (que no requieran tratamiento antibiótico local ni general), prurito o dolor aislado en el lugar de inyección.
    • Episodios de cetosis y cetoacidosis diabética (CAD), definidos por un aumento de los niveles de cetonemia (capilar) relacionados con hiperglucemia (GP superior a 300 mg/dl [16,7 mmol/l]).
    • Hipoglucemia (sintomática diurna y nocturna, grave, asintomática).
    • Datos de seguridad: acontecimientos adversos, constantes vitales.

    - En momentos específicos
    • Glucosa plasmática en ayunas (GPA) y HbA1c en las semanas 0, 13, 26 y 39.
    • Niveles de glucemia medidos por el paciente de 7 puntos: inmediatamente antes y 2 horas después del comienzo del desayuno, almuerzo y cena, y a las 3:00 de la madrugada. Se realizará durante 2 dos días seguidos en la semana anterior a la visita 2 y en la semana anterior al final de cada periodo de tratamiento.
    • Dosis de insulina: se anotará la dosis diaria basal total (índices basales), la dosis de los bolos y la hora de administración durante los 2 últimos días de las fases de ajuste de la dosis, y cuando se realicen los perfiles de glucemia (7 puntos).
    • Peso corporal: en las semanas 0, 13, 26 y 39.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Yes
    E.8.1.7Other Information not present in EudraCT
    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 Information not present in EudraCT
    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 EEA31
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 188
    F.4.2.2In the whole clinical trial 270
    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 Decision2008-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
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