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    The EU Clinical Trials Register currently displays   44241   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-011222-34
    Sponsor's Protocol Code Number:SYR-322_402
    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:2009-10-22
    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 number2009-011222-34
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar resultados cardiovasculares después del tratamiento con alogliptina en combinación con la asistencia habitual en sujetos con diabetes tipo 2 y síndrome coronario agudo.

    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate
    Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome
    A.4.1Sponsor's protocol code numberSYR-322_402
    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 SponsorTakeda Global Research & Development Centre (Europe) Ltd.
    B.1.3.4CountryUnited Kingdom
    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 nameAlogliptina
    D.3.2Product code SYR-322; SYR110322
    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.3.8INN - Proposed INNAlogliptina
    D.3.9.1CAS number 850649-62-6
    D.3.9.2Current sponsor codeSYR-322; SYR110322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    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 nameAlogliptina
    D.3.2Product code SYR-322; SYR110322
    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.3.8INN - Proposed INNAlogliptina
    D.3.9.1CAS number 850649-62-6
    D.3.9.2Current sponsor codeSYR-322; SYR110322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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.IMP: 3
    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 nameAlogliptina
    D.3.2Product code SYR-322; SYR110322
    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.3.8INN - Proposed INNAlogliptina
    D.3.9.1CAS number 850649-62-6
    D.3.9.2Current sponsor codeSYR-322; SYR110322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.25
    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 placeboFilm-coated tablet
    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 2 (DMT2) y síndrome coronario agudo (SCA).

    type 2 diabetes mellitus (T2DM) and acute coronary syndrome (ACS)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar que no existe exceso de riesgo de ACAI (acontecimientos cardíacos adversos importantes) después del tratamiento con alogliptina en comparación con placebo cuando se administra en combinación con la asistencia habitual en sujetos con DMT2 y SCA. Para los fines de este estudio, la combinación de ACAI principal consta de muerte por causas CV, infarto de miocardio (IM) no mortal e ictus no mortal.
    El criterio de valoración principal será el tiempo transcurrido entre la aleatorización y la aparición de un primer episodio de la combinación de ACAI principal.
    E.2.2Secondary objectives of the trial
    Evaluar el tiempo transcurrido entre la aleatorización y la aparición de un primer episodio de la combinación de ACAI secundaria: muerte por causas CV, IM no mortal, ictus no mortal y revascularización urgente por angina de pecho inestable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    La elegibilidad de los sujetos se determinará de acuerdo con los criterios siguientes:
    1. Sujetos de ambos sexos, mayores de 18 años y con un diagnóstico de DMT2 que, o bien están recibiendo tratamiento antidiabético en monoterapia o en combinación (con la excepción de un inhibidor de la DPP-4 o un análogo del GLP-1) antes de la selección.
    2. Los sujetos deberán cumplir los siguientes requisitos de HbA1c basados en el tratamiento basal siguiente:
    o Si el régimen antidiabético de un sujeto incluye monoterapia oral o una combinación por vía oral, debe tener una cifra de HbA1c entre el 7,0% y el 10,0%, ambos inclusive, en el momento de selección.
    o Si el régimen antidiabético incluye insulina, debe tener una cifra de HbA1c entre el 7,0% y el 9,0%, ambos inclusive, en el momento de selección.
    3. El sujeto tiene antecedentes de SCA (IM agudo o angina inestable que requiere hospitalización) en los 15 a 60 días anteriores a la aleatorización.
    4. Las mujeres en edad fértil y los varones sexualmente activos deberán comprometerse a utilizar de forma sistemática un método anticonceptivo adecuado a partir del momento de selección y durante todo el estudio.
    NOTA: por definición, se consideran NO fértiles las mujeres que han sido esterilizadas quirúrgicamente (histerectomía, ovariectomía bilateral, ligadura de trompas) o que son posmenopáusicas (definidas como las que tienen una edad mínima de 45 años y han tenido su última menstruación regular un año antes, como mínimo).
    5. El sujeto o su representante legal es capaz de otorgar su consentimiento informado por escrito y está dispuesto a otorgarlo antes de la realización de ningún procedimiento del estudio.
    6. El sujeto es capaz de entender y cumplir los requisitos del protocolo, incluidas las citas clínicas programadas.
    E.4Principal exclusion criteria
    No podrán participar en el estudio los sujetos que cumplan alguno de los criterios siguientes:
    1. El sujeto tiene signos de diabetes mellitus de tipo 1, incluidos los antecedentes de cetoacidosis o la necesidad de insulina durante el año posterior al diagnóstico de la diabetes mellitus.
    2. El sujeto está recibiendo un análogo del GLP-1 para controlar la glucemia de la DMT2 en el momento de selección.
    3. El sujeto ha recibido un inhibidor de la DPP-4 durante más de 14 días en total o en los 3 meses anteriores a la selección.
    4. El sujeto presenta cualquier trastorno CV hemodinámicamente inestable, como insuficiencia cardíaca (clase 4 de la NYHA), angina de pecho resistente, arritmias cardíacas incontroladas, cardiopatía valvular crítica e hipertensión arterial grave en el momento de selección.
    5. El sujeto ha sufrido un episodio de SCA menos de 15 días antes de la aleatorización según la definición recogida en el Apéndice E.
    6. El sujeto está hospitalizado en el momento de la visita basal/de aleatorizacion.
    7. El sujeto ha recibido diálisis en los 14 días anteriores a la selección.
    8. El sujeto tiene antecedentes de infección por el virus de la inmunodeficiencia humana.
    9. El sujeto tiene antecedentes de alcoholismo o drogadicción en los 6 meses anteriores a la visita de selección.
    10. El sujeto ha recibido un medicamento en investigación de cualquier tipo en los 30 días anteriores a la visita de selección o un medicamento antidiabético en investigación en los 3 meses anteriores a la visita de selección.
    11. El sujeto padece alguna enfermedad o debilidad importante que, a juicio del investigador, le impide participar en el estudio.
    12. El sujeto es un trabajador de un centro del estudio o un familiar directo (p. ej., cónyuge, padre, hijo o hermano) de un trabajador de un centro del estudio que participa en la realización de este estudio.
    13. En caso de que el sujeto sea una mujer, está embarazada (confirmación mediante un análisis de laboratorio, es decir, gonadotropina coriónica humana [hCG] en suero u orina, en las mujeres en edad fértil), tiene intención de quedarse embarazada durante el estudio o está dando el pecho.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal será el tiempo transcurrido entre la aleatorización y la aparición de un primer episodio de la combinación de ACAI principal:
    • Muerte por causas CV.
    • IM no mortal.
    • Ictus no mortal.
    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 No
    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 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 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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA364
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Un representante legal del sujeto puede proporcionar el consentimiento informado escrito en su nombre, pero, aún así, el sujeto debe ser capaz de entender y cumplir los requisitos del protocolo, incluidas las citas clínicas programadas.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2700
    F.4.2.2In the whole clinical trial 5400
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Después de su participación en el estudio, se prevé que cualquier decisión o asesoramiento relacionada con el tto. posterior de los pacientes la tomará su médico de cabecera basándose en las terapias disponibles y los tratamientos para su enfermedad de acuerdo con su asistencia habitual.
    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 Decision2009-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-10
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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