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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2010-021069-63
    Sponsor's Protocol Code Number:BCB109(H8O-MC-GWDQ)
    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:2014-03-17
    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 number2010-021069-63
    A.3Full title of the trial
    A randomized, placebo, controlled clinical trial to evaluate cardiovascular outcomes after treatment with Exenatide Once Weekly in patients with type 2 diabetes mellitus
    ENSAYO CLÍNICO ALEATORIZADO, CONTROLADO CON PLACEBO, PARA EVALUAR LOS RESULTADOS CLÍNICOS CARDIOVASCULARES TRAS EL TRATAMIENTO CON EXENATIDA UNA VEZ A LA SEMANA EN PACIENTES CON DIABETES MELLITUS DE TIPO 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test the Effects of Exenatide Once Weekly on Cardiovascular Outcomes in Patients with Type 2 Diabetes
    A.3.2Name or abbreviated title of the trial where available
    EXenatide Study of Cardiovascular Event Lowering Trial (EXSCEL)
    A.4.1Sponsor's protocol code numberBCB109(H8O-MC-GWDQ)
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmylin Pharmaceuticals, LLC
    B.1.3.4CountryUnited States
    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 supportAmylin Pharmaceuticals, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPAREXEL International
    B.5.2Functional name of contact pointProject Leader
    B.5.3 Address:
    B.5.3.1Street AddressEdificio Sollube - Plaza de Carlos Trías Bertrán, 7 ? 7ª plta.
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28020
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932174 716
    B.5.5Fax number+34913183 810
    B.5.6E-mailcarmen.andres@parexel.com
    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 BYDUREON 2mg
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/AstraZeneca EEIG
    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 nameExenatide
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    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 INNExenatide
    D.3.9.1CAS number 141732-76-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboPowder and solvent for suspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes mellitus
    Diabetes Mellitus Tipo 2
    E.1.1.1Medical condition in easily understood language
    Cardiovascular disease in patients with type 2 diabetes
    Enfermedad Cardiovascular en pacientes con Diabetes Mellitus tipo 2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of EXSCEL will be to evaluate the effect of exenatide once weekly (EQW), used in addition to the current usual care for glycemic control, on major macrovascular events when administered to patients with type 2 diabetes.
    El objetivo principal de EXSCEL es evaluar los efectos de EUS una vez a la semana, en su adición al tratamiento habitual actual para el control de la glucemia, sobre los acontecimientos macrovasculares mayores en su administración a pacientes con diabetes de tipo 2.
    E.2.2Secondary objectives of the trial
    The secondary objectives of EXSCEL are to evaluate the effect of EQW treatment used in addition to the current usual care for glycemic control on:
    (1) All cause mortality
    (2) Each of the components of the primary composite CV endpoint
    (3) Hospitalization for acute coronary syndrome (ACS)
    (4) Hospitalization for congestive heart failure (CHF)
    Los objetivos secundarios de EXSCEL son evaluar los efectos del tratamiento con EUS utilizado en adición al tratamiento habitual actual para el control glucémico sobre:
    1) Muerte por todas las causas
    2) Cada uno de los componentes del criterio de valoración CV compuesto principal
    3) Hospitalización por síndrome coronario agudo (SCA)
    4) Hospitalización por insuficiencia cardiaca congestiva (ICC)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Patients enrolled in the trial will have the option to consent separately to provide a whole blood sample for future pharmacogenomic analyses. The objective of collecting blood samples from which genetic analyses can be performed is to investigate the relationships between genetic make-up and clinical events. These samples will be drawn at baseline, or at any point in the trial at which consent is obtained from the patient.
    Patients enrolled in the trial will be asked to consent separately to provide two blood and one urine samples for future biomarker analyses. These specimens (preferably fasting) will be obtained at baseline (prior to drug exposure), annually and trial/early termination.
    A los pacientes participantes en el ensayo se les pedirá su consentimiento por separado para la obtención de una muestra de sangre completa para futuros análisis farmacogenómicos. El objetivo de la recogida de muestras de sangre para la práctica de análisis genéticos es investigar las relaciones entre la estructura genética y los acontecimientos clínicos. Dichas muestras se obtendrán en el momento basal o en cualquier otro momento del ensayo en el que el paciente otorgue su consentimiento
    E.3Principal inclusion criteria
    - Patient has type 2 diabetes mellitus
    - Patient will able to see a usual care provider at least twice a year
    - Patient has an HbA1c of >= 6.5% and <= 10.0% and is currently using one of the following treatment regimens:
    ?Treatment with up to three (i.e., 0-3) oral AHAs (concomitant use of DPP-4 inhibitors is permitted).
    ?Insulin therapy, either alone or in combination with up to two (ie., 0-2) oral AHAs (use of basal and prandial insulins is permitted in any combination of individual or premixed insulins)
    All patients should be on a stable diabetes management regimen, as assessed by the investigator, at the time of enrollment.
    - Patients with any level of CV risk.
    - Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
    - Patient agrees to provide permission to obtain all medical records necessary for complete data ascertainment during the follow-up period, and agrees to communication between the trial site and the usual care provider in order to facilitate routine care.
    - Patient is 18 years or older at enrollment.
    a) Diabetes mellitus de tipo 2
    b) Paciente capaz de acudir a su médico habitual como mínimo dos veces al año
    c) Paciente con HbA1c >= 6,5 % y <= 10,0% y que actualmente está con uno de los siguientes regímenes terapéuticos:
    ? Tratamiento con un máximo de tres (es decir, 0-3) AAH orales (se permite el uso concomitante de inhibidores de DPP-4)
    ? Insulina, bien sola o en combinación con un máximo de dos (es decir, 0-2) AAH orales (se permite el uso de insulinas basales y prandiales en cualquier combinación de insulinas individuales o premezclas)
    - Pacientes con cualquier nivel de riesgo CV.
    - Las mujeres no podrán estar amamantando y deberán mostrar su conformidad en utilizar un método anticonceptivo eficaz o, en caso contrario, no tener riesgo de embarazo.
    - Paciente que da su autorización para la obtención de todos los documentos médicos necesarios para poder disponer de los datos completos durante el período de seguimiento y que está de acuerdo en la comunicación entre el centro del estudio y su médico habitual para facilitar su atención normal.
    -Paciente de 18 años o más en el momento de su reclutamiento
    E.4Principal exclusion criteria
    - Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
    - Patient has a history (>= 2 episodes) of severe hypoglycemia within 12 months of enrollment.
    - Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. exenatide BID, exenatide once weekly, liraglutide, lixisenatide, albiglutide, taspoglutide, or dulaglutide.
    - Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
    - Patient has a planned or anticipated revascularization procedure.
    - Pregnancy or planned pregnancy during the trial period.
    - Patient has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient, confound the results of the trial e.g. if patient cannot comply with requirements of the trial, or likely to interfere with the patient?s participation for the full duration of the trial.
    - Patient has end-stage renal disease or an estimated glomerular filtration rate of <30 mL/min/1.73 m2.
    - Patient has a history of gastroparesis.
    - Personal or family history of medullary thyroid cancer or MEN2 (Multiple Endocrine Neoplasia Type 2) or calcitonin level > 40ng/L at baseline.
    - Patient has previously been enrolled in EXSCEL.
    - Patient has a history of pancreatitis.
    - Is an employee of Amylin Pharmaceuticals LLC, Bristol-Myers Squibb Company or AstraZeneca.
    - Paciente con diagnóstico de diabetes mellitus de tipo 1 o antecedentes de cetoacidosis.
    - Paciente con antecedentes (>= 2 episodios) de hipoglucemia severa en el plazo de los 12 meses anteriores a su reclutamiento.
    -Paciente que ha recibido tratamiento en algún momento con un agonista del receptor de GLP-1, ya sea aprobado o en investigación, como, por ejemplo, BYETTA (exenatida), BYDUREON (EUS), VICTOZA (liraglutida), LYXUMIA (lixisenatida), albiglutida, taspoglutida o dulaglutida.
    -Paciente que está participando en otro protocolo experimental que supone el uso de un medicamento o producto sanitario en investigación o de una intervención que pudiera interferir con el desarrollo de este ensayo.
    - Paciente con procedimiento de revascularización programado o previsible
    - Embarazo o búsqueda de embarazo durante el periodo del ensayo
    - Paciente con antecedente o evidencia actual de cualquier proceso, tratamiento, anomalía de laboratorio u otra circunstancia que, en opinión del investigador o coordinador, pueda conllevar un riesgo inaceptable para el paciente, confundir los resultados del ensayo (por ejemplo, si el paciente no pudiera cumplir con los requisitos del ensayo) o con probabilidad de interferir con la participación del paciente durante toda la duración del ensayo
    - Paciente con nefropatía terminal o con una tasa de filtración glomerular estimada (TFGe) obtenida a partir de su creatinina sérica (utilizando la fórmula sencilla del MDRD-4) <30 mL/min/1,73m2
    - Paciente con historia de gastroparesia
    - Antecedentes personales o familiares de cáncer medular de tiroides o de MEN2 (neoplasia endocrina múltiple de tipo 2) o nivel de calcitonina> 40 ng/L en el momento basal.
    - Paciente que ya ha sido anteriormente aleatorizado en EXSCEL
    - Paciente con antecedente de pancreatitis
    - Paciente que es empleado de Amylin Pharmaceuticals, LLC, Bristol -Myers Squibb Company, o de AstraZeneca
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint: Time to first confirmed CV event in the primary composite CV endpoint. Defined as the time from randomization to first confirmed CV-related death, nonfatal MI or nonfatal stroke.
    Criterio de valoración principal de la eficacia:Tiempo hasta el primer acontecimiento CV confirmado del criterio de valoración CV compuesto principal.Definido como el tiempo desde la aleatorización al primer acontecimiento confirmado de muerte de causa CV, IM no fatal o accidente cerebrovascular no fatal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1360 patients with positively adjudicated primary endpoint events have been accrued
    1360 pacientes con el criterio de valoracíón principal de eficacia positivamente adjudicado acumulados
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    - Time to all-cause mortality. Defined as time from randomization to death due to any cause.
    - Time to first confirmed CV event for each component of the primary composite endpoint.
    - Time to hospitalization for acute coronary syndrome.
    - Time to hospitalization for heart failure.
    Criterios secundarios de valoración de la eficacia
    ? Tiempo hasta el fallecimiento por cualquier causa
    Definido como el tiempo desde la aleatorización a la muerte por cualquier causa.
    ? Tiempo hasta el primer acontecimiento CV confirmado de cada componente del criterio de valoración CV compuesto principal.
    ? Tiempo hasta la hospitalización por síndrome coronario agudo.
    ? Tiempo hasta la hospitalización por insuficiencia cardiaca
    E.5.2.1Timepoint(s) of evaluation of this end point
    1360 patients with positively adjudicated primary endpoint events have been accrued
    1360 pacientes con el criterio de valoracíón principal de eficacia positivamente adjudicado acumulados.
    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 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 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 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.8.2.4Number of treatment arms in the trial2
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA261
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bulgaria
    Canada
    China
    Netherlands
    New Zealand
    Argentina
    Australia
    Brazil
    Chile
    Colombia
    Hong Kong
    India
    Korea, Republic of
    Malaysia
    Spain
    Thailand
    Israel
    Mexico
    Peru
    Philippines
    Russian Federation
    South Africa
    Taiwan
    Ukraine
    United States
    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
    LVLS
    Ultima visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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.1.2.1Number of subjects for this age range: 10500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3500
    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 state114
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5355
    F.4.2.2In the whole clinical trial 14000
    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)
    Standard care treatment
    Tratamiento médico 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 Decision2014-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-24
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