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    Summary
    EudraCT Number:2010-021069-63
    Sponsor's Protocol Code Number:BCB109(H8O-MC-GWDQ)
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    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
    Randomizovaná, placebem kontrolovaná klinická studie hodnotící výskyt kardiovaskulární příhody u pacientů s diabetes mellitus 2. typu po léčbě exenatidem podávaném jednou týdně.
    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 holderAstraZeneca AB
    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 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 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
    E.1.1.1Medical condition in easily understood language
    Cardiovascular disease in patients with type 2 diabetes
    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 20.0
    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.
    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)
    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.
    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.
    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.
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1360 patients with positively adjudicated primary endpoint events have been accrued
    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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1360 patients with positively adjudicated primary endpoint events have been accrued
    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 Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number 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 concerned6
    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
    Argentina
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Hong Kong
    India
    Israel
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Peru
    Philippines
    Russian Federation
    South Africa
    Spain
    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
    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 state230
    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
    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 Decision2011-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-24
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