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    Summary
    EudraCT Number:2010-021069-63
    Sponsor's Protocol Code Number:H8O-MC-GWDQ
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-02
    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 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” (EXSCEL: EXenatide Study of Cardiovascular Event Lowering Trial)
    Studio EXSCEL (EXenatide Study of Cardiovascular Event Lowering). Uno studio clinico randomizzato, controllato verso placebo per la valutazione degli esiti cardiovascolari in seguito a trattamento con exenatide una volta alla settimana in pazienti con diabete mellito di tipo 2.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    .....
    .....
    A.3.2Name or abbreviated title of the trial where available
    EXSCEL
    EXSCEL
    A.4.1Sponsor's protocol code numberH8O-MC-GWDQ
    A.5.4Other Identifiers
    Name:.....Number:.....
    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 SponsorELI LILLY
    B.1.3.4CountryItaly
    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 supportElli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationElli Lilly and Company
    B.5.2Functional name of contact point.....
    B.5.3 Address:
    B.5.3.1Street AddressLilly House, Priestley Road
    B.5.3.2Town/ cityBasingstoke, Hampshire
    B.5.3.3Post codeRG24 9NL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44.1276.483403
    B.5.5Fax number+44.1276.483378
    B.5.6E-mailBayley_Janis@Lilly.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 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.3.10.3Concentration 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
    Diabete mellito di tipo 2
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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.1.3Condition 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 EQW, used in conjunction with the current usual care for glycemic control, on major macrovascular events when administered to patients with type 2 diabetes.
    L’obiettivo primario dello studio EXSCEL e' valutare, nei soggetti partecipanti con diabete di tipo 2, l’effetto di EQW in aggiunta alla terapia standard corrente per il controllo della glicemia, sui maggiori eventi macrovascolari quando amministrato in pazienti affetti da diabete di tipo 2.
    E.2.2Secondary objectives of the trial
    The secondary objectives of EXSCEL are to evaluate the effect of EQW treatment used in conjunction with 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 heart failure (CHF)
    Gli obiettivi secondari dello studio EXSCEL sono tesi a valutare l’effetto del trattamento con EQW utilizzato in combinazione con lo standard di cura corrente per il controllo della glicemia sui seguenti eventi:
    1.Mortalita' per tutte le cause;
    2.Ciascuna delle componenti dell’endpoint primario composito di eventi CV;
    3.Ospedalizzazione per sindrome coronarica acuta (SCA);
    4.Ospedalizzazione per scompenso cardiaco congestizio (CHF).
    E.2.3Trial contains a sub-study Yes
    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 ≥ 7.0 % and ≤ 10.0% on stable doses of up to three (i.e. 0-3) oral AHAs for at least 3 months i.e. no oral AHA adjustments in the past 3 months. Concomitant use of DPP-4 inhinbitors is permitted. - 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.
    - Il/la paziente presenta diabete mellito di tipo 2; -Il/la paziente dovra' essere in grado di recarsi dal medico curante almeno due volte all’anno. Il/la paziente presenta livelli di HbA1c 7,0% e 10,0% ed e' trattato/a da almeno 3 mesi con dosi stabili di un massimo di tre (i.e. 0-3) agenti antiperglicemici (AHA) orali, ovvero la terapia con AHA orali non deve aver subito aggiustamenti di dose negli ultimi 3 mesi. E' permesso l’uso di inibitori della DPP-4. -Saranno ritenuti validi solo i valori di HbA1c esaminati entro i tre mesi precedenti alla randomizzazione. Qualora in quei tre mesi fossero stati effettuati piu' esami e quindi siano disponibili piu' valori di HbA1c allora si terra' in considerazione il valore piu' recente. Per un/una paziente la cui HbA1c sia &gt;10,0% sara' possibile, a discrezione dello sperimentatore, procedere all’aggiustamento della terapia orale a base di AHA e sottoporre nuovamente il/la paziente a screening per l’idoneita' alla randomizzazione relativamente alla HbA1c (7,0% e 10,0%) dopo un periodo di 3 mesi a dosi stabili di AHA. -Possono essere arruolati i pazienti con qualsiasi livello di rischio CV e che soddisfano tutti gli altri criteri di inclusione. L’arruolamento sara' controllato in modo tale da ottenere approssimativamente un 40% di pazienti non interessati da precedenti eventi CV e un 60% di pazienti interessati da un precedente evento CV definito come almeno uno dei seguenti: storia di manifestazione clinica maggiore di coronaropatia, ovvero infarto del miocardio, procedura chirurgica o percutanea (palloncino e/o stent) di rivascolarizzazione coronarica o angiografia coronarica che evidenzi almeno una stenosi 50% in un’arteria epicardica maggiore o in una diramazione vascolare; -malattia cerebrovascolare ischemica, tra cui: storia di ictus ischemico. Gli ictus non emorragici saranno accettati in questo criterio; storia di arteriopatia carotidea documentata da stenosi 50% rilevata tramite ecocardiografia della carotide, risonanza magnetica (RM) o angiografia, con o senza sintomi di deficit neurologico; arteriopatia periferica aterosclerotica documentata da evidenza obiettiva come amputazione dovuta a vasculopatia, sintomi correnti di claudicazione intermittente confermata da un indice pressorio caviglia-braccio o alluce-braccio inferiore a 0,9 o storia di procedura chirurgica o di rivascolarizzazione percutanea. Le pazienti di sesso femminile non devono essere in stato di allattamento e devono acconsentire ad utilizzare un metodo di contraccezione efficace o diversamente non devono essere a rischio di sviluppare una gravidanza. Il/la paziente comprende le procedure dello studio, i trattamenti alternativi disponibili, i rischi correlati allo studio e acconsente volontariamente a partecipare fornendo il suo consenso informato scritto. Il/la paziente acconsente a fornire l’autorizzazione a ottenere tutte le cartelle cliniche necessarie per un completo accertamento dei dati durante il periodo di follow-up, nonche' alla comunicazione tra il centro di studio e il medico curante per facilitare la terapia di routine. Il/la paziente e' maggiorenne all’arruolamento.
    E.4Principal exclusion criteria
    Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis. - Patient has taken insulin within 2 weeks of screening visit or for greater than 1 week within 3 months of screening visit. - Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), EQW, VICTOZA (liraglutide), or taspoglutide. - 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 Multiple Endocrine Neoplasia Type 2 or calcitonin level of 100 ng/L or greater. - Patient has a history of pancreatitis.
    Il/la paziente presenta una diagnosi di diabete mellito di tipo 1 o una storia di chetoacidosi. Il/la paziente ha assunto insulina nelle 2 settimane precedenti la visita di screening o per piu' di una settimana nei 3 mesi precedenti la visita di screening. Il/la paziente e' stato precedentemente trattato/a con un agonista del recettore del GLP-1 approvato o sperimentale, p. es. BYETTA (exenatide), EQW, VICTOZA (liraglutide) o taspoglutide. Il/la paziente e' arruolato/a in un altro protocollo sperimentale che comporta l’utilizzo di un farmaco o dispositivo sperimentale o un intervento che interferirebbe con la conduzione dello studio. Il/la paziente ha programmato o prevede una procedura di rivascolarizzazione. La paziente e' in stato di gravidanza o pianifica una gravidanza durante il periodo di studio. Il/la paziente presenta una storia medica indicante un’aspettativa di vita &lt;2 anni o che potrebbe limitare la sua capacita' di assumere i trattamenti in studio nel corso della sperimentazione. Il/la paziente presenta una storia o evidenze correnti di qualsiasi condizione, terapia, anomalia nei risultati degli esami di laboratorio o altra circostanza che, nell’opinione dello sperimentatore o del coordinatore, potrebbe comportare rischi inaccettabili per la sua sicurezza, confondere i risultati dello studio (p. es. se il/la paziente non e' in grado di attenersi ai requisiti dello studio), o che potrebbe interferire con la sua partecipazione per l’intera durata dello studio. Il/la paziente presenta una malattia renale allo stadio terminale o una velocita' stimata di filtrazione glomerulare (eGFR) derivata dalla creatinina sierica (mediante la formula MDRD semplificata a 4 parametri) di &lt;30 mL/min/1,73 m2. Il/la paziente presenta un’allergia o un’intolleranza nota a exenatide. Il/la paziente presenta una storia di gastroparesi. Storia personale o familiare di cancro midollare della tiroide o neoplasia endocrina multipla di tipo 2 o livelli di calcitonina 100 ng/L. NOTA: i campioni di siero per la misurazione della calcitonina saranno prelevati allo screening. I pazienti possono essere randomizzati e iniziare il trattamento con il farmaco in studio prima che siano disponibili i risultati dell’esame della calcitonina. Qualora un/una paziente randomizzato/a risulti avere una concentrazione di calcitonina sierica tale da comportare la sua esclusione dallo studio, il trattamento con il farmaco in studio sara' sospeso e il/la paziente continuera' a essere monitorato/a per valutare il suo stato vitale e a far parte dell’analisi ”intention to treat”. Il/la paziente e' stato/a precedentemente arruolato/a nello studio EXSCEL. Il/la paziente presenta una storia di pancreatite.
    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. 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.
    Endpoint di efficacia primaria: Tempo al primo evento CV confermato dell’endpoint primario composito di eventi CV. Definito come il tempo dalla randomizzazione al primo decesso confermato per cause CV, IM non fatale o ictus non fatale.

    Endpoint di efficacia secondaria: -Tempo alla mortalita' per tutte le cause. Definito come il tempo dalla randomizzazione al decesso dovuto a qualsiasi causa. -Tempo al primo evento CV confermato per ciascun componente dell’endpoint primario composito. Definito come il tempo dalla randomizzazione a un decesso confermato per cause CV, IM non fatale o ictus non fatale. -Tempo all’ospedalizzazione per sindrome coronarica acuta. Definito come il tempo dalla randomizzazione a un ricovero ospedaliero confermato per angina instabile o infarto del miocardio con o senza sopraslivellamento del tratto ST. -Tempo all’ospedalizzazione per scompenso cardiaco. Definito come il tempo dalla randomizzazione al ricovero ospedaliero per scompenso cardiaco congestizio che necessita trattamento con diuretici endovenosi, inotropi o terapia con vasodilatatori.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study No
    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.8.2.4Number 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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA147
    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
    Ukraine
    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
    SI prega di fare riferimento al Protocollo
    SI prega di fare riferimento al Protocollo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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 Information not present in EudraCT
    F.1.1Number of subjects for this age range: 0
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2832
    F.4.2.2In the whole clinical trial 9500
    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)
    ....
    ....
    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 Decision2011-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-24
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