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    Summary
    EudraCT Number:2007-002456-41
    Sponsor's Protocol Code Number:1218.15
    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:2008-02-14
    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 number2007-002456-41
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, de grupos paralelos, controlado con placebo, de 24 semanas de duración, para evaluar la eficacia y seguridad de BI 1356 (5 mg) en combinación con pioglitazona 30 mg (ambos administrados por vía oral una vez al día) comparado con pioglitazona 30 mg más placebo, en pacientes con diabetes tipo 2 sin tratamiento previo o tratados previamente pero con un control insuficiente de la glucemia
    A randomised, double-blind, placebo controlled, parallel group 24 week study to assess the efficacy and safety of BI 1356 (5 mg) in combination with 30 mg pioglitazone (both administered orally once daily), compared to 30 mg pioglitazone plus placebo in drug naive or previously treated type 2 diabetic patients with insufficient glycaemic control.
    A.3.2Name or abbreviated title of the trial where available
    Eficacia versus placebo de la terapia inicial combinada con pioglitazona
    A.4.1Sponsor's protocol code number1218.15
    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 SponsorBoehringer Ingleheim España, 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 No
    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 nameBI 1356
    D.3.2Product code BI1356
    D.3.4Pharmaceutical form Film-coated 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.3.9.2Current sponsor codeBI 1356
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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) Information not present in EudraCT
    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
    Pacientes con Diabetes Melitus tipo 2 con control glucémico insuficiente.
    Patients with type 2 Diabetes Mellitus with insufficient glycaemic control.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II 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
    El objetivo de este estudio es investigar la eficacia, seguridad y tolerabilidad de BI 1356 (5 mg/una vez al día) en comparación con placebo administrado durante 24 semanas como tratamiento inicial en combinación con pioglitazona 30mg en pacientes con diabetes mellitus tipo 2 con control glucémico insuficiente.

    The objective of the study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Todos los pacientes deberán firmar un consentimiento informado de conformidad con las guías de BPC de la ICH (Buena Práctica Clínica de la Conferencia Internacional de Armonización) antes de su participación en el estudio (se debe obtener el consentimiento informado escrito para el reclutamiento en el estudio antes de realizar cambios en la medicación o realizar procedimientos necesarios para cumplir los criterios de inclusión).
    2. Pacientes con un diagnóstico de diabetes mellitus tipo 2 anterior al consentimiento informado, con o sin tratamiento previo con un hipoglucemiante oral.
    3. Hemoglobina A1 glucosilada (HbA1c) en la visita 1a (selección)
    Para pacientes que pasan por un periodo de lavado de la medicación previa: HbA1c 7,0-9,5%.
    Para pacientes que no necesitan un periodo de lavado de la medicación previa: HbA1c 7,5-11,0%.
    4. Hemoglobina A1 glucosilada (HbA1c) 7,5-11,0% en la visita 2 (inicio del periodo de preinclusión).
    5. Pacientes de ambos sexos y con edades comprendidas entre los 18 y los 80 años, ambas inclusive, en la visita 1a (selección).
    6. Índice de masa corporal (IMC)  40 kg/m2 en la visita 1a (selección).
    E.4Principal exclusion criteria
    1. Infarto de miocardio, ictus o AIT en los 6 meses anteriores a la obtención del consentimiento informado.
    2. Alteración de la función hepática, definida por concentraciones séricas de ALT (SGPT), AST (SGOT) o fosfatasa alcalina (FA) > 3 veces el límite superior de la normalidad (LSN), determinados en la visita 1a.
    3. Hipersensibilidad o alergia conocidas al producto en investigación o a sus excipientes, hipersensibilidad o alergia a la pioglitazona clorhidrato o a sus excipientes (carmelosa cálcica, hiprolosa, lactosa monohidrato, estearato de magnesio).
    4. Tratamiento con un agonista/análogo inyectable de GLP-1 en los 3 meses anteriores a la obtención del consentimiento informado.
    5. Tratamiento con insulina en los 3 meses anteriores a la obtención del consentimiento informado.
    6. Tratamiento con fármacos anti-obesidad (p. ej., sibutramina, orlistat, rimonabant) en los 3 meses anteriores a la obtención del consentimiento informado.
    7. Alcoholismo o toxicomanía en los 3 meses anteriores a la obtención del consentimiento informado, que pudiera interferir en la participación en el estudio.
    8. Participación en otro estudio con un fármaco experimental en los 2 meses anteriores a la obtención del consentimiento informado.
    9. Mujeres premenopáusicas (última menstruación  1 año antes de la firma del consentimiento informado) que:

    - están en periodo de lactancia o embarazadas

    - o poseen capacidad para concebir y no utilizan un método anticonceptivo aceptable o no planean continuar utilizando este método durante todo el estudio y no acceden a someterse a una prueba de embarazo periódica durante su participación en el estudio. Entre los métodos anticonceptivos aceptables se incluyen parches transdérmicos, dispositivos/sistemas intrauterinos (DIU/SIU), anticonceptivos orales, implantables o inyectables, abstinencia sexual y pareja vasectomizada. No se realizará ninguna excepción.
    10. Tratamiento con corticoesteroides sistémicos o cambios en la dosis de hormona tiroidea en las seis semanas anteriores al consentimiento informado.
    11. Glucemia en ayunas > 240 mg/dl (= 13,3 mmol/l) en la selección.
    12. Insuficiencia cardiaca de clase III-IV según la clasificación de la NYHA (clase III: pacientes con limitaciones marcadas de la actividad; sólo están cómodos en reposo; Clase IV: pacientes que deben permanecer en reposo total, confinados en cama o silla; cualquier actividad física les provoca molestias y sufren síntomas en reposo) o antecedentes de insuficiencia cardiaca antes de este estudio.
    13. Cetoacidosis diabética en los 6 meses anteriores a la obtención del consentimiento informado.
    14. Pacientes en hemodiálisis, por la experiencia limitada con TZD en estos pacientes.
    15. Cualquier otra afección clínica que, en opinión del investigador, no permitiera la finalización segura del ensayo clínico y la administración segura de BI 1356 y pioglitazona.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de este estudio será la variación del valor HbA1c basal respecto al valor de HbA1c tras 24 semanas de tratamiento.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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) Information not present in EudraCT
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA72
    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 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
    Aquellos pacientes que finalicen el periodo de tratamiento del estudio de 24 semanas tendrán la opción de participar en un estudio abierto de extensión. Este estudio se tratará como un protocolo separado y los pacientes deberán otorgar nuevamente su consentimiento para participar.
    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 days
    E.8.9.2In all countries concerned by the trial years1
    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 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) No
    F.1.1.6Adolescents (12-17 years) No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 520
    F.4.2.2In the whole clinical trial 750
    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 Decision2008-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-19
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