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    Summary
    EudraCT Number:2009-011222-34
    Sponsor's Protocol Code Number:SYR-322_402
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-08-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-011222-34
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate
    Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome

    A.4.1Sponsor's protocol code numberSYR-322_402
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00968708
    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 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 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 codeWC2B 4AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+440203116 8000
    B.5.5Fax number+440203116 8199
    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 nameAlogliptin
    D.3.2Product code SYR-322; SYR110322
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNAlogliptin
    D.3.9.1CAS number 850649-62-6
    D.3.9.2Current sponsor codeSYR-322; SYR110322
    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) 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.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 nameAlogliptin
    D.3.2Product code SYR-322; SYR110322
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNAlogliptin
    D.3.9.1CAS number 850649-62-6
    D.3.9.2Current sponsor codeSYR-322; SYR110322
    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) 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.IMP: 3
    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 nameAlogliptin
    D.3.2Product code SYR-322; SYR110322
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNAlogliptin
    D.3.9.1CAS number 850649-62-6
    D.3.9.2Current sponsor codeSYR-322; SYR110322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.25
    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 placeboFilm-coated tablet
    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) and acute coronary syndrome (ACS)
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes mellitus and Acute coronary syndrome (a medical emergency that requires immediate hospital admission).
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that no excess risk of composite MACE exists following treatment with alogliptin compared with placebo when given in combination with Standard of Care in subjects with T2DM and ACS. For purposes of this study, the primary MACE composite comprises CV death, nonfatal MI, and nonfatal stroke.
    E.2.2Secondary objectives of the trial
    To demonstrate superiority of alogliptin versus placebo with respect to the primary MACE composite: CV death, nonfatal MI and nonfatal stroke. To evaluate time from randomization to the first occurrence of any event in the secondary MACE composite: CV death, nonfatal MI, nonfatal
    stroke, and urgent revascularization due to unstable angina.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    optional Pharmacogenomic sub-study: section 6.2.1 of main protocol

    DNA samples will be used to study genetic factors contributing to the subjects’ response to alogliptin in terms of efficacy and safety and cardiovascular and metabolic outcomes. The objective of this pharmacogenomic study is to gain a better understanding of the association of genetic variation on the response to study medication and the risk of cardiovascular and metabolic disease.
    E.3Principal inclusion criteria
    Subject eligibility is determined according to the following criteria:
    1. Male or female subjects 18 years of age or older who have a diagnosis of T2DM, who either are receiving monotherapy or combination antidiabetic therapy (with the exception of a DPP-4 inhibitor or GLP-1 analogue) prior to Screening.
    2. Subjects must meet the following HbA1c requirements based on the following baseline therapy: (please note that HbA1c can be repeated during Screening):
    • If a subject’s antidiabetic regimen includes oral monotherapy or oral combination therapy, the subject must have an HbA1c level between 6.5% and 11.0%, inclusive, at Screening.
    • If the subject’s antidiabetic regimen includes insulin, the subject must have an HbA1c level between 7% and 11%, inclusive, at Screening.
    3. Subject has a history of ACS (acute MI or unstable angina requiring hospitalization as defined in Appendix E) within 15 to 90 days prior to randomization.
    4. Female subjects of childbearing potential who are sexually active who agree to routinely use adequate contraception from Screening throughout the duration of the study.
    NOTE: Women NOT of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation) or who are postmenopausal (defined as at least 45 years and above and at least 1 year since last regular menses).
    5. Subject or the subject’s legally acceptable representative is able and willing to provide written informed consent prior to the initiation of any study procedures.
    6. The subject is capable of understanding and complying with protocol requirements, including scheduled clinic appointments.
    E.4Principal exclusion criteria
    Any subject who meets any of the following criteria will not qualify for entry into the study:
    1. Subject has signs of or is diagnosed with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
    2. Subject is currently receiving a GLP-1 analogue for glycemic control of T2DM at Screening.
    3. Subject has received a DPP-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening.
    4. Subject has any hemodynamically unstable CV disorder including heart failure (NYHA Class 4), refractory angina, uncontrolled arrhythmias, critical valvular heart disease, and severe hypertension at Screening.
    5. Subject has had an ACS event less than 15 days prior to randomization according to the definition outlined in Appendix E of protocol.
    6. Subject is hospitalized at Baseline/Randomization Visit. Subjects who have been discharged from an acute hospital to a cardiac rehabilitation center or nursing home at Baseline/Randomization Visit are not excluded.
    7. Subject has received dialysis within 14 days prior to Screening.
    8. Subject has a history of infection with human immunodeficiency virus.
    9. Subject has a history of alcohol or substance abuse within the 6 months prior to the Screening Visit.
    10. Subject has received any investigational drug within the 30 days prior to the Screening Visit or has received an investigational antidiabetic drug within the 3 months prior to the Screening Visit.
    11. Subject has any major illness or debility that, in the investigator’s opinion, prohibits the subject from participating in the study.
    12. The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, and sibling) of a study site employee who is involved in conduct of this study.
    13. Subject is pregnant (confirmed by laboratory testing, ie, serum/urine human chorionic gonadotropin [hCG]) in females of childbearing potential), intends to become pregnant during the study, or is lactating.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the time from randomization to the first occurrence of any event in the primary MACE (major adverse cardiac event) composite:
    - CV death.
    - Nonfatal MI.
    - Nonfatal stroke.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A primary MACE composite event could occur at any time during the study, so there is no fixed timepoint for evaluation of an individual event. Unblinded analyses of accrued events will be performed at the intervals described in the protocol(section 13.1.4)
    E.5.2Secondary end point(s)
    The secondary endpoint will be the time from randomization to the first occurrence of any event in the secondary MACE composite:
    - CV death.
    - Nonfatal MI.
    - Nonfatal stroke.
    - Urgent revascularization due to unstable angina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A secondary MACE composite event could occur at any time during the study, so there is no fixed timepoint for evaluation of an individual event. Unblinded analyses of accrued events will be performed at the intervals described in the protocol(section 13.1.4)
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA301
    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
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Denmark
    Egypt
    Finland
    France
    Germany
    Greece
    Guatemala
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Japan
    Jordan
    Korea, Republic of
    Kuwait
    Latvia
    Lithuania
    Malaysia
    Mexico
    New Zealand
    Peru
    Philippines
    Poland
    Portugal
    Puerto Rico
    Qatar
    Romania
    Russian Federation
    Saudi Arabia
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Arab Emirates
    United Kingdom
    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
    Last visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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 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: 4500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 900
    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
    A subject’s legally acceptable representative may provide written informed consent on their behalf, however, the subject must still be capable of understanding and complying with the protocol requirements, including scheduled clinic appointments.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1500
    F.4.2.2In the whole clinical trial 5400
    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)
    After participation in the trial, it is envisaged that any decision or advice concerning further treatment of patients will be made by their usual health care providers based on the available therapies and treatments for their condition in
    accordance with their usual standard of care
    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 Decision2009-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-10
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