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    Summary
    EudraCT Number:2011-001732-37
    Sponsor's Protocol Code Number:TAK-875_306
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-09-13
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-001732-37
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects with Type 2 Diabetes and with Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events
    Studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato con placebo, volto a valutare gli outcomes cardiovascolari registrati in seguito all'assunzione di TAK-875, 50 mg in aggiunta alla terapia standard in soggetti affetti da diabete di tipo 2 in presenza di malattia cardiovascolare o di fattori di rischio multipli per episodi cardiovascolari.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Cardiovascular Outcomes after TAK-875 or placebo assumption
    Valutazione gli outcomes cardiovascolari registrati in seguito all'assunzione di TAK-875 o del placebo.
    A.3.2Name or abbreviated title of the trial where available
    TAK-875, 50 mg CV Ouycomes Study
    TAK-875, 50 mg Studio sugli outcomes CV
    A.4.1Sponsor's protocol code numberTAK-875_306
    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 SponsorTAKEDA EUROPE RESEARCH & DEVELOPMENT CENTRE 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 supportTakeda Global Research & Development Centre (Europe) Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Global Research & Development Centre (Europe) Ltd.
    B.5.2Functional name of contact pointProgram Manager
    B.5.3 Address:
    B.5.3.1Street Address61 Aldwych
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2B4AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044 02031168000
    B.5.5Fax number0044 02031168199
    B.5.6E-mailclinicaloperations@tgrd.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 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 nameTAK-875
    D.3.2Product code TAK-875
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 codeTAK-875
    D.3.9.3Other descriptive nameTAK-875
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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
    Type 2 diabetes mellitus (T2DM)
    Diabete mellito di tipo 2 (T2DM)
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Diabete di 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 15.0
    E.1.2Level LLT
    E.1.2Classification code 10063624
    E.1.2Term Type II diabetes mellitus inadequate control
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10029505
    E.1.2Term Non-insulin-dependent diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    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 is to demonstrate that no excess risk of CV
    composite events exists following treatment with
    TAK-875 compared with placebo when given in combination with
    Standard of Care in subjects with T2DM and clinically evident CV disease
    or multiple risk factors for CV events. For purposes of this study, the
    primary MACE composite comprises CV death, nonfatal myocardial
    infarction (MI), nonfatal stroke, and hospitalization for unstable angina
    (with or without revascularization).
    L’obiettivo primario è dimostrare che non esiste un rischio eccessivo di eventi CV compositi a seguito di trattamento con TAK-875, rispetto al placebo, se somministrato in combinazione con la terapia standard in soggetti con T2DM e malattia CV clinicamente manifesta o fattori di rischio multipli per eventi CV. Per gli scopi del presente studio, il MACE primario composito comprende il decesso CV, l’infarto miocardico (IM) non fatale, l’ictus non fatale e il ricovero per angina instabile (con o senza rivascolarizzazione).
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate time from randomization to
    secondary MACE composite: CV death, nonfatal MI, and nonfatal stroke.
    L’obiettivo secondario è di valutare il tempo dalla randomizzazione al MACE secondario composito: decesso CV, IM non fatale e ictus non fatale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who are 18 years of age or older;
    2. Have a diagnosis of T2DM with an HbA1c between 7.0% and 10.5%,
    inclusive;
    3. Subjects must have documentation of one of 3 High Risk factors
    (documented history of myocardial infarction, documented symptomatic
    peripheral arterial disease, or documented cerebrovascular disease), or
    have one of 4 Intermediate Risk factors (stable angina, multi vessel
    XML File Identifier: 3KIxJCkHVYW4I3hdCWePdfXWVDM=
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    coronary disease, history of percutaneous coronary intervention, or
    specific clinical criteria);
    4. Stable baseline ALT or AST levels;
    5. Subject is able and willing to monitor glucose with a home glucose
    monitor and consistently record blood glucose concentrations in diaries;
    6. If female of childbearing potential and sexually active with a nonsterilized
    male partner, agrees to use adequate contraception
    throughout duration of the study and for 30 days after last dose of study
    medication.
    Soggetti di almeno 18 anni di età; con diagnosi di T2DM, con HbA1c tra 7,0% e 10,5%, inclusi; i soggetti devono avere documentazione di uno dei 3 fattori di rischio CV elevati (anamnesi documentata di IM, malattia arteriosa periferica sintomatica documentata o malattia cerebrovascolare documentata) o avere documentazione di uno dei 4 fattori di rischio CV intermedi (angina stabile, malattia coronarica multivasale, anamnesi di intervento coronarico percutaneo o criteri clinici specifici); livelli di ALT o AST stabili al basale; soggetto in grado e disposto a monitorare il glucosio a casa con un glucosimetro e a registrare regolarmente le concentrazioni di glucosio ematico nei diari; se di sesso femminile, in età fertile e sessualmente attiva con un partner di sesso maschile non sterilizzato, disposta ad adottare una contraccezione adeguata per l’intera durata dello studio e per 30 giorni dopo l’ultima dose del farmaco dello studio.
    E.4Principal exclusion criteria
    1. Subjects who have received any investigational medication within 30
    days prior to Screening or any investigational
    antidiabetic medication or excluded medications within 3 months prior to
    Screening;
    2. Have been randomized into a previous TAK-875 study;
    3. Are an immediate family member, study site employee, or are in a
    dependant relationship with a study site employee involved in the
    conduct of this study;
    4. Are diagnosed with type 1 diabetes mellitus or latent
    autoimmune diabetes in adults;
    5. Hemodynamically unstable, including severe heart failure (New York
    Heart Association Class IV);
    6. Hospitalized at Screening Visit for the cardiovascular inclusion event;
    7. Have an alanine aminotransferase (ALT) and/or aspartate
    aminotransferase (AST) level >3.0x upper limit of normal (ULN); 8. Have
    a total bilirubin level >ULN at screening;
    9. Have an estimated glomerular filtration rate (eGFR) ≤15
    mL/min/1.73m2 based on Modification of Diet in Renal Disease (MDRD)
    calculation and is not currently or expected to start dialysis within the
    next 6 months;
    10. Have uncontrolled thyroid disease;
    11. Have a known history of infection with human
    immunodeficiency virus (HIV);
    12. Have a known history of active infection with Hepatitis B virus (HBV)
    or Hepatitis C virus (HCV) requiring antiviral treatment;
    13. Have a history of drug or alcohol abuse within the 2 years prior to
    Screening;
    14. Have a history of hypersensitivity, allergies, or has had an
    anaphylactic reaction(s) to TAK-875;
    15. Have a history of cancer that has been in remission for <5 years
    prior to Screening, with the exception of basal cell carcinoma
    or Stage 1 squamous cell carcinoma of the skin;
    16. If female, is pregnant or lactating or intending to become pregnant
    or donate ova throughout the study period and within 1 month after.
    Soggetti che: hanno ricevuto un qualsiasi farmaco sperimentale entro 30 giorni dallo Screening o un qualsiasi farmaco antidiabetico sperimentale o farmaci non autorizzati entro 3 mesi dallo Screening; sono stati randomizzati in un precedente studio su TAK-875; sono familiari diretti, impiegati del centro dello studio o in una relazione di dipendenza con un/a impiegato/a del centro dello studio coinvolto/a nella conduzione del presente studio; hanno una diagnosi di diabete mellito di tipo 1 o diabete autoimmune latente dell’adulto; presentano instabilità emodinamica, tra cui grave insufficienza cardiaca (classe IV in base alla New York Heart Association); in occasione della visita di Screening per l’evento di inclusione CV vengono ricoverati; hanno un livello di alanina aminotrasferasi (ALT) e/o di aspartato aminotrasferasi (AST) &gt;3,0 volte il limite superiore di normalità (Upper Limit of Normal, ULN); hanno un livello di bilirubina totale &gt; ULN allo Screening; hanno una velocità di filtrazione glomerulare stimata (estimated Glomerular Filtration Rate, eGFR) ≤15 ml/min/1,73m2 in base al calcolo della Modificazione della dieta nella malattia renale (Modification of Diet in Renal Disease, MDRD), attualmente non sottoposti a dialisi o per i quali non si prevede di iniziare la dialisi nei successivi 6 mesi; hanno una malattia tiroidea incontrollata; hanno un’anamnesi nota di infezione da virus dell’immunodeficienza umana (HIV); hanno un’anamnesi nota di infezione attiva da virus dell’epatite B (HBV) o da virus dell’epatite C (HCV) che richieda trattamento antivirale; hanno un’anamnesi di abuso di alcol o droghe entro 2 anni dallo Screening; hanno un’anamnesi di ipersensibilità, allergie o reazione/i anafilattica/che a TAK-875; hanno un’anamnesi di cancro, che è stato in remissione per &lt;5 anni dallo Screening, ad eccezione del carcinoma cutaneo basocellulare o squamocellulare di stadio 1; o se di sesso femminile, sono incinte o in allattamento, o intendono rimanere incinte o donare ovuli nel corso del periodo dello studio ed entro 1 mese dopo la sua fine.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the time from randomization to
    the first occurrences of any event in the primary
    MACE composite (CV death, nonfatal MI, nonfatal stroke, hospitalization
    for unstable angina, with or without
    revascularization).
    L’endpoint primario per questo studio è il tempo dalla randomizzazione alle prime manifestazioni di un qualunque evento rientrante nel MACE primario composito (decesso CV, IM non fatale, ictus non fatale e ricovero per angina instabile, con o senza rivascolarizzazione).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint for evaluation of primary endpoint will depend on when any of
    the events in the primary MACE composite will occur.
    Il tempo di rilevazione di tale end point primario dipende da quando si verificheranno eventi di MACE primario composito.
    E.5.2Secondary end point(s)
    Secondary endpoint for this study is the time from randomization to the
    first occurrence of any event in the secondary MACE composite (CV
    death, nonfatal MI, nonfatal stroke).
    L’endpoint secondario per questo studio è il tempo dalla randomizzazione alla prima manifestazione di un qualunque evento rientrante nel MACE secondario composito (decesso CV, IM non fatale, ictus non fatale).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint for evaluation of secondary endpoint will depend on when any
    of the events in the secondary MACE composite will occur.
    Il tempo di rilevazione di tale end point primario dipende da quando si verificheranno eventi di MACE secondario composito.
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA152
    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
    Argentina
    Australia
    Brazil
    Canada
    China
    Croatia
    Guatemala
    Hong Kong
    Israel
    Korea, Democratic People's Republic of
    Korea, Republic of
    Malaysia
    Mexico
    New Zealand
    Peru
    Philippines
    Russian Federation
    South Africa
    Taiwan
    Thailand
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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.1.1Number of subjects for this age range: 0
    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.1.2.1Number of subjects for this age range: 2000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3000
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1170
    F.4.2.2In the whole clinical trial 5000
    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)
    The subject should be returned to the care of a physician and standard therapies as required.
    Il soggetto deve essere restituito alle cure di un medico e alle terapie standard come richiesto.
    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 Decision2013-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-12-27
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