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    Summary
    EudraCT Number:2005-002115-24
    Sponsor's Protocol Code Number:H9D-MC-ITAB
    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:2005-07-11
    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 number2005-002115-24
    A.3Full title of the trial
    Reclamaciones asociadas al uso de la pluma precargada B en pacientes con diabetes tipo 2 tratados con insulina dos veces al día
    A.4.1Sponsor's protocol code numberH9D-MC-ITAB
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 Information not present in EudraCT
    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 nameinsulin lispro low mix prefilled pen B
    D.3.2Product code LY275585(P)
    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 INNinsulin lispro
    D.3.9.1CAS number 133107-64-9
    D.3.9.2Current sponsor codeLY275585
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 tipo II
    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
    El objetivo principal es obtener datos de las reclamaciones sobre la pluma precargada B utilizada por personas con diabetes tipo 2 para autoadministrarse insulina de forma ambulatoria durante dos meses. Estos datos contribuirán a la evaluación de la pluma precargada B antes de su lanzamiento.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios del estudio son:

    Vigilar la seguridad, incluidos todos los acontecimientos adversos, la hipoglucemia, la hipoglucemia relacionada con el dispositivo y la hiperglucemia relacionada con el dispositivo

    Evaluar la percepción global por parte del paciente del rendimiento del dispositivo mediante un cuestionario.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Los pacientes son elegibles para ser incluidos en el estudio sólo si cumplen todos los criterios siguientes:
    [1] Padecen diabetes tipo 2 de acuerdo con los criterios diagnósticos de la enfermedad (anexo del protocolo ITAB.3).
    [2] Están recibiendo una formulación de insulina de Lilly (una o dos inyecciones al día de uno o dos tipos de insulina) o van a comenzar el tratamiento con insulina.
    [3] Para los pacientes que ya están recibiendo insulina, tienen un valor de HbA1c hasta 1,75 veces el límite superior de la normalidad (LSN) del intervalo de referencia del laboratorio local en los 30 días previos a la visita 1. Para los pacientes que van a recibir tratamiento con insulina por primera vez, tienen un valor de HbA1c entre 1,25 y 1,75 veces el LSN del intervalo de referencia del laboratorio local en los 30 días previos a la visita 1.
    [4] Tienen entre 25 y 75 años de edad, inclusive, en el momento de la visita 1.
    [5] En opinión del investigador, tienen la motivación adecuada y la intención de alcanzar y mantener un buen control de la glucemia por medio de una vigilancia periódica de la glucemia y, cuando proceda, de ajustes de la dosis.
    [6] En opinión del investigador, son capaces de y están dispuestos a:
    · inyectarse ellos mismos con la pluma precargada B, y
    · usar el diario del paciente de acuerdo con este protocolo
    [7] Han dado su consentimiento informado por escrito para participar en este estudio, de acuerdo con la normativa local.
    E.4Principal exclusion criteria
    Se excluirá a los pacientes del estudio si cumplen alguno de los criterios siguientes:
    [8] Toman actualmente, o han estado tomando en el mes anterior, un ADO no aprobado para usarse en combinación con insulina en el país del paciente.
    [9] Tienen antecedentes de trasplante renal o están recibiendo actualmente diálisis renal.
    [10] Han recibido tratamiento crónico (durante más de dos semanas) con glucocorticoides sistémicos (excepto preparados tópicos e inhalatorios) en los seis meses previos a la visita 1 o están recibiendo actualmente tratamiento sistémico con glucocorticoides.
    [11] Han sufrido más de tres episodios inexplicados de hipoglucemia grave en los seis meses previos a la entrada en el estudio. Se define hipoglucemia grave como aquélla en la que el paciente necesita ayuda de otra persona y que está asociada a un nivel de glucemia inferior a 2,8 mmol/l (50 mg/dl) o que se resuelve rápidamente después de la administración de hidratos de carbono orales, glucosa intravenosa o glucagón. Esta definición incluye todos los episodios en los que la afectación neurológica es suficientemente intensa para impedir el tratamiento por el propio paciente y que, por consiguiente, se considera que ponen a los pacientes en riesgo de lesionarse ellos mismos o lesionar a otras personas (DCCT 1991).
    [12] Saben que están embarazadas o tienen previsto quedarse embarazadas durante el estudio.
    [13] Padecen una enfermedad maligna conocida distinta del cáncer basocelular o espinocelular de la piel.
    [14] Padecen un déficit visual que les impide usar el dispositivo sin ayuda.
    [15] Padecen otros trastornos (como toxicomanías, alcoholismo o enfermedades psiquiátricas) que, en opinión de investigador, impiden que el paciente siga y complete el protocolo.
    [16] Han completado previamente este estudio o se han retirado del mismo después de dar el consentimiento informado por escrito.
    [17] Pertenecen al personal del centro del investigador directamente vinculado al estudio, o son familiares inmediatos del personal del centro del investigador directamente vinculado al estudio. Se define familiares inmediatos como cónyuges, padres, hijos o hermanos, tanto biológicos como legales.
    [18] Trabajan para Lilly (es decir, son empleados, trabajadores por contrato temporal o personas designadas responsables de la realización del estudio). Los familiares inmediatos de los trabajadores de Lilly pueden participar en ensayos clínicos patrocinados por Lilly, pero no pueden participar en un centro de Lilly. Se define familiares inmediatos como cónyuges, padres, hijos o hermanos, tanto biológicos como legales.
    [19] Han recibido tratamiento en los últimos 30 días con un fármaco que no ha recibido la aprobación oficial para cualquier en el momento de la entrada en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal es obtener datos de las reclamaciones sobre la pluma precargada B utilizada por personas con diabetes tipo 2 para autoadministrarse insulina de forma ambulatoria durante dos meses. El objetivo no es estudiar la insulina sino la pluma.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    REcoger datos de las reclamaciones como parte de la evaluacion de la pluma precargada (b)
    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) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    El estudio tendra tres visitas y el paciente terminara el estudio cuando complete las tres visitas o dicontinue. El periodo de tratamiento durara entre 7 y 9 semanas
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    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 2005-07-11. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 265
    F.4.2.2In the whole clinical trial 370
    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 Decision2005-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-04-26
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