Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36348   clinical trials with a EudraCT protocol, of which   5989   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-007444-34
    Sponsor's Protocol Code Number:SYR-322_305
    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:2009-06-29
    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 number2008-007444-34
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego y con control activo para evaluar la duración de la eficacia y la seguridad de la alogliptina en comparación con glipizida utilizada en combinación con metformina en sujetos con diabetes de tipo 2

    A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination with Metformin in Subjects with Type 2 Diabetes
    A.4.1Sponsor's protocol code numberSYR-322_305
    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
    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
    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
    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
    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 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 Glipizide 5 mg tablets, BP
    D.2.1.1.2Name of the Marketing Authorisation holderGenerics UK Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameGlipizida
    D.3.4Pharmaceutical form Capsule, hard
    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 INNGlipizida
    D.3.9.1CAS number 29094-61-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 4
    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 Glucophage 500
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sante s.a.s
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameMetformina
    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 INNHidrocloruro de metformina
    D.3.9.1CAS number 1115-70-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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: 5
    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 Glucophage 850
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sante s.a.s
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameMetformina
    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 INNHidrocloruro de metformina
    D.3.9.1CAS number 1115-70-4
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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 mellitus de tipo II (DMT2) actualmente en tratamiento con una dosis diaria estable de metformina sola, pero que tienen un control glucémico insuficiente.

    Patients with type II diabetes mellitus (T2DM) who are currently treated with a stable daily dose of metformin alone but experiencing inadequate glycemic 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
    Evaluar la duración (hasta 2 años aproximadamente) de la eficacia de la alogliptina más metformina en comparación con glipizida más metformina medida por medio del cambio de la HbA1c desde la visita basal hasta la semana 52 ó 104 en adultos con DMT2
    E.2.2Secondary objectives of the trial
    - Evaluar otras medidas del control glucémico después del tratamiento con alogliptina más metformina en comparación con glipizida más metformina, incluidos el cambio de HbA1c con respecto a la visita basal en otra visita y el cambio de GA con respecto a la visita basal en todas las visitas.

    - Evaluar niveles de importancia clínica de la respuesta de HbA1c después del tratamiento con alogliptina más metformina en comparación con glipizida más metformina.

    - Evaluar los cambios en el peso corporal después del tratamiento con alogliptina más metformina en comparación con glipizida más metformina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Varones o mujeres de 18 a 80 años de edad con diagnóstico de DMT2.
    2. Los sujetos deben cumplir una de las siguientes condiciones:
    a) Control insuficiente con una dosis diaria estable > ó = 1.500 mg (o DMT documentada) de metformina durante al menos los 2 meses anteriores a la selección. El control glucémico insuficiente se define como una concentración de HbA1c > ó = 6,5 y < ó = 9,0%. Estos sujetos entrarán de inmediato en el periodo de estabilización siguiendo el calendario del estudio A.
    b) Control insuficiente (definido por un valor de HbA1c > ó = 7,5 y < ó = 10%) con una dosis de metformina <1.500 mg sin DMT documentada. Después de la visita previa a la selección, a estos sujetos se les aumentará inmediatamente la dosis de metformina hasta > ó = 1.500 mg (o DMT) durante 8 semanas de conformidad con el calendario del estudio B. Después de este periodo de 8 semanas, el sujeto debe cumplir las condiciones para entrar en el periodo de estabilización completando la visita de selección con un control glucémico insuficiente definido como una concentración de HbA1c > ó = 6,5 y < ó = 9,0%.
    3. No se admitirá el tratamiento con otros medicamentos antidiabéticos distintos de la metformina en los 2 meses anteriores a la selección (excepción: el sujeto ha recibido algún otro tratamiento antidiabético durante menos de 7 días en los 2 meses anteriores a la selección).
    4. Índice de masa corporal (IMC) > ó = 23 kg/m2 y < ó = 45 kg/m2.
    5. Concentración de péptido C en ayunas > ó = 0,8 ng/ml (> ó = 0,26 nmol/l).
    6. Los sujetos que tomen regularmente otros medicamentos no excluidos deben recibir una dosis estable durante al menos las 4 semanas anteriores a la selección. Sin embargo, el uso S/N (según necesidad) de medicamentos con o sin receta médica se permite a criterio del investigador.
    7. Las mujeres en edad fértil y los varones sexualmente activos deberán comprometerse a utilizar un método anticonceptivo adecuado desde el momento de selección y durante todo el estudio.

    NOTA: por definición, se consideran NO fértiles las mujeres esterilizadas quirúrgicamente o posmenopáusicas (definidas como las que han tenido su última menstruación regular hace al menos dos años). En la sección 9.1.13 Métodos anticonceptivos y evitación del embarazo se definen los métodos anticonceptivos aceptables.
    8. El sujeto o su representante legal es capaz de otorgar un consentimiento informado por escrito y está dispuesto a otorgarlo antes de la realización de cualquier procedimiento del estudio.
    9. El sujeto es capaz de entender y cumplir los requisitos del protocolo, incluidas las visitas programadas.
    10. El sujeto es capaz y está dispuesto a obtener determinaciones de la glucemia en su casa con un glucómetro y de completar los diarios.

    Además, para poder aleatorizar al paciente, hay que contestar afirmativamente a los siguientes criterios:
    1. Concentración de HBA1c > ó = 6,5% y < ó = 9,0% en la visita de la semana -1. (Si el sujeto no es apto para la aleatorización según este criterio, se puede repetir la determinación una vez a la semana durante otras 2 semanas como máximo.)
    2. GA <275 mg/dl (15,27 mmol/l) en la visita de la semana -1. (Si el sujeto no es apto para la aleatorización según este criterio, se puede repetir la determinación una vez a la semana durante otras 2 semanas como máximo.)
    3. Cumplimiento del 75% como mínimo, pero no más del 125%, de la pauta del medicamento en régimen abierto (metformina) durante el periodo de estabilización, según lo determinado por el recuento de comprimidos.
    4. No se permite el uso de glucocorticoides sistémicos inyectados (incluida la inyección intrarticular) u orales ni de medicamentos de reducción del peso durante los 3 meses anteriores a la aleatorización. (Sí se permite el uso de corticosteroides tópicos e inhalados.)
    E.4Principal exclusion criteria
    No podrán incorporarse al estudio los sujetos que cumplan cualquiera de los siguientes criterios:
    1. Presión arterial sistólica > ó = 150 mm Hg y/o presión diastólica > ó = 90 mm Hg en la visita de selección.
    2. Hemoglobina < ó = 12 g/dl (< ó = 120 g/l) en varones y < ó = 10 g/dl (< ó = 100 g/l) en mujeres.
    3. Alanina aminotransferasa >2,5 x límite superior de la normalidad.
    4. Creatinina en suero > ó = 1,5 mg/dl en varones y > ó = 1,4 mg/dl en mujeres o aclaramiento de creatinina < ó = 50 ml/min calculada por el laboratorio central mediante la aproximación de Cockcroft-Gault.
    5. Mujeres en edad fértil que tengan pensado quedarse embarazadas durante el estudio o que estén embarazadas (confirmado por una prueba de laboratorio, por ejemplo hCG en suero u orina) o que estén en periodo de lactancia.
    6. Sujetos con antecedentes de cáncer, excepto carcinoma escamocelular o basocelular de la piel que no haya estado en remisión completa durante al menos durante los 5 años anteriores a la selección. (Se admiten antecedentes de NIC I, II o III [neoplasia intraepitelial cervical] tratada.)
    7. Sujetos con antecedentes de tratamiento con láser para la retinopatía diabética proliferativa durante los 6 meses anteriores a la selección.
    8. Sujetos con antecedentes de parálisis gástrica diabética tratada, colocación de bandas elásticas en el estómago o cirugía de bypass gástrico.
    9. Sujetos con insuficiencia cardiaca de clase III o IV de la New York Heart Association con independencia del tratamiento. Pueden incorporarse al estudio los sujetos en tratamiento y estabilizados en la clase I o II.
    10. Sujetos con antecedentes de angioplastia coronaria, colocación de un stent coronario, cirugía de bypass coronario, infarto de miocardio, ictus o accidente isquémico transitorio (AIT) en los 3 meses anteriores a la selección.
    11. Sujetos con antecedentes de hemoglobinopatía que pueda afectar a la determinación de la HbA1c.
    12. Sujetos con antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH), el virus de la hepatitis B (VHB) o el virus de la hepatitis C (VHC).
    13. Sujetos con antecedentes de algún trastorno psiquiátrico que afecte a la capacidad para participar en el estudio.
    14. Sujetos con antecedentes de abuso de alcohol o de sustancias en los 2 años anteriores a la selección.
    15. Sujetos que hayan recibido cualquier medicamento en investigación en los 30 días anteriores a la selección o que hayan recibido algún medicamento antidiabético en investigación en los 3 meses anteriores a la selección.
    16. Sujetos que hayan recibido cualquier medicamento antidiabético inhibidor de la DPP-IV o miméticos del GLP-1 en cualquier visita anterior a la selección.
    17. Sujetos con alguna enfermedad o debilidad importante que, a juicio del investigador, le impidan completar el estudio.
    18. Sujetos con tratamiento previo en un estudio de investigación de la alogliptina.
    19. Sujetos que sean empleados del centro del estudio o familiares en primer grado (cónyuge, padre, hijo, hermano) de un empleado del centro del estudio que intervenga en la realización de este estudio.
    20. Sujetos con antecedentes de hipersensibilidad o alergia o que hayan tenido una reacción anafiláctica a algún inhibidor de de la DPP-IV, a la metformina o a la glipizida.
    21. Mujeres embarazadas o lactantes o que hayan planificado quedarse embarazarse antes de su participación en el estudio, durante éste o durante el mes siguiente a su terminación o que quieran donar óvulos durante dicho periodo.
    22. Varones que quieran engendrar un hijo o donar esperma durante antes del estudio, durante éste o durante el mes siguiente al final de su participación en el estudio.
    23. Sujetos que no entiendan el inglés hablado o escrito o el idioma en el cual haya una traducción certificada del consentimiento informado aprobado.
    E.5 End points
    E.5.1Primary end point(s)
    Cambio de la HbA1c con respecto la visita basal en las semanas 52 ó 104
    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 Yes
    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) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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 legalmente aceptable puede proporcionar el CI por escrito en nombre del sujeto, no obstante este último debe ser capaz de entender y cumplir las exiguencias del protocolo, incluidas las visitas al hospital programadas.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state104
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1100
    F.4.2.2In the whole clinical trial 2691
    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)
    Los pacientes volverán al cuidado habitual, según criterio del investigador.
    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 Decision2009-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-03
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA