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    Summary
    EudraCT Number:2008-006719-20
    Sponsor's Protocol Code Number:0431-082
    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:2010-12-09
    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 number2008-006719-20
    A.3Full title of the trial
    TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TECOS: A Cardiovascular Outcomes Study for Type 2 Diabetes
    A.3.2Name or abbreviated title of the trial where available
    TECOS
    A.4.1Sponsor's protocol code number0431-082
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.
    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 supportMerck Sharp & Dhome Corp., a subsidiary of Merck & Co.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Regional Business Support Center GmbH
    B.5.2Functional name of contact pointDr. Steven Hildemann
    B.5.3 Address:
    B.5.3.1Street AddressLindenplatz 1
    B.5.3.2Town/ cityHaar
    B.5.3.3Post code85540
    B.5.3.4CountryGermany
    B.5.4Telephone number+498962731350
    B.5.5Fax number+4989456655222
    B.5.6E-mailSteven.Hildemann@essex.de
    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 Januvia
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd.
    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 nameJanuvia 25 mg film-coated tablets
    D.3.2Product code MK-0431
    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 INNSitagliptin
    D.3.9.1CAS number 790712-60-6
    D.3.9.2Current sponsor codeMK-0431
    D.3.9.3Other descriptive nameSitagliptin phosphate monohydrate
    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 Yes
    D.2.1.1.1Trade name Januvia
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd.
    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 nameJanuvia 100 mg film-coated tablets
    D.3.2Product code MK-0431
    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 INNSitagliptin
    D.3.9.1CAS number 790712-60-6
    D.3.9.2Current sponsor codeMK-0431
    D.3.9.3Other descriptive nameSitagliptin phosphate monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 2
    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)
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    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 compare the impact of including sitagliptin as part of usual care vs. usual care without sitagliptin on CV outcomes as measured by the time to first event in the primary CV composite endpoint of CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.
    E.2.2Secondary objectives of the trial
    To compare the impact of including sitagliptin as part of usual care vs. usual care without sitagliptin on:
    1 The time to first event in a secondary composite CV endpoint of CV-related death, nonfatal MI, and nonfatal stroke
    2 The time to first event for each of the following individual CV
    endpoints: confirmed CV-related death, MI (fatal + nonfatal), stroke
    (fatal + nonfatal), and unstable angina requiring hospitalization.
    3 All-cause mortality
    4 Hospital admissions for congestive heart failure as reported by the investigator;
    5 Change from baseline in HbA1c over time
    6 Change in renal function and albuminuria over time
    7 In patients not receiving insulin at baseline, time to initiation of long-term insulin therapy. Long term insulin therapy is defined as a continuous period of insulin use of more than 3 months
    8 In patients not receiving insulin at baseline, time to addition of first co-interventional agent
    9 Medical resource utilization during the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Patient has T2DM with HbA1c of ≥ 6.5% (48 mmol/mol) and ≤ 8.0% (64 mmol/mol) (HbA1c must be documented within 3 months prior to study enrollment) while receiving metformin, pioglitazone, or a sulfonylurea as monotherapy or any dual combination of metformin, pioglitazone, or a sulfonylurea continuously without alteration in dose for at least 3 months OR a stable dose of insulin (±20% of the scheduled total daily insulin dose) either alone or in combination with a stable dose of metformin for at least 3 months
    b. Patient is able to see a usual care provider at least twice a year
    c. Patient is ≥ 50 years of age with preexisting vascular disease, defined as having any one of the following:
    c.1 History of a major clinical manifestation of coronary artery disease (i.e., myocardial infarction, surgical or percutaneous [balloon and/or stent] coronary revascularization procedure, or coronary angiography showing at least one stenosis ≥ 50% in a major epicardial artery or branch vessel);
    c.2 Ischemic cerebrovascular disease, including:
    c.2.1 History of ischemic stroke. Strokes not known to be hemorrhagic will be allowed as part of this criterion;
    c.2.2 History of carotid arterial disease as documented by ≥ 50 % stenosis documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography, with or without symptoms of neurologic deficit.
    c.3 Atherosclerotic peripheral arterial disease, as documented by objective evidence such as amputation due to vascular disease, current symptoms of intermittent claudication confirmed by an ankle-brachial pressure index or toe brachial pressure index less than 0.9 or history of surgical or percutaneous revascularization procedure.
    d. Female patients agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
    e. Patient understands the study procedures, alternative treatments available, and the risks involved with the study, and voluntarily agrees to participate by providing written informed consent.
    f. Patient agrees to provide permission to obtain all medical records necessary for complete data ascertainment during the follow-up period.
    E.4Principal exclusion criteria
    a. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
    b. Patient has a history of ≥2 episodes of severe hypoglycemia during the 12 months prior to enrollment. Severe hypoglycemia (hypoglycemia requiring assistance) refers to instances in which the patient was sufficiently disoriented or incapacitated as to require help from either another individual or from medical personnel (whether or not this assistance was actually provided).
    c. Patient has taken an approved or investigational DPP-4 inhibitor agent (e.g., sitagliptin, alogliptin, saxagliptin, or vildagliptin), or GLP-1 analogue (e.g., exenatide, exenatide LAR, or liraglutide), or a thiazolidinedione other than pioglitazone within the past 3 months.
    d. Patient has cirrhosis of the liver, as assessed by medical history.
    e. 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.
    f. Patient has a planned or anticipated revascularization procedure.
    g. Pregnancy or planned pregnancy during the trial period.
    h. Patient has medical history that indicates a life expectancy of < 2 years or might limit the individual’s ability to take trial treatments for the duration of the study.
    i. Patient has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose a risk to the patient, make participation not in the patient’s best interest, confound the results of the study (e.g., if patient cannot comply with requirements of the study), or interfere with the patient’s participation for the full duration of the study.
    j. Patient has an estimated GFR (calculated based on serum creatinine via the MDRD formula) of < 30 mL/min/1.73 m2.
    k. Patient has a known allergy or intolerance to sitagliptin.
    l. Patient has previously been enrolled in this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first confirmed CV in the primary composite CV endpoint: defined
    as the time from randomization to first confirmed event in the primary
    composite CV endpoint (CV-related death, nonfatal MI, nonfatal stroke,
    or unstable angina requiring hospitalization).
    E.5.1.1Timepoint(s) of evaluation of this end point
    CV endpoints are captured at baseline, month 4, month 8, annual visits (month 12, 24, 36, 48, 60, 72), telephone contacts, brief visits (month 18, 30, 42, 54, 66), end of study, and post-study phone contact
    E.5.2Secondary end point(s)
    - Time to first confirmed CV event in the secondary composite CV
    endpoint: defined as time from randomization to first confirmed event in the secondary composite CV endpoint (CV-related death, nonfatal MI, or nonfatal stroke).
    - Time to first confirmed CV event for individual CV endpoints: defined as time from randomization to each of the components of the primary
    composite endpoint (CV-related death, MI [fatal + nonfatal], stroke
    [fatal +nonfatal], and unstable angina requiring hospitalization).
    - Time to all-cause mortality: defined as time from randomization to death due to any cause.
    - Time to congestive heart failure: defined as time from randomization to hospital admission for congestive heart failure and treatment with
    intravenous diuretics, inotropes, or vasodilator therapy.
    - Change from baseline in urinary albumin to creatinine ratio over time.
    - Change from baseline in eGFR over time.
    - Change from baseline in HbA1c over time.
    - Time to initiation of chronic insulin therapy: defined as continuous use
    longer than three months in patients not receiving insulin at baseline.
    - Time to initiation of first co-interventional agent (i.e., next oral AHA or chronic insulin therapy in patients not receiving insulin at baseline).
    - Count of hospitalizations for any reason.
    E.5.2.1Timepoint(s) of evaluation of this end point
    (1, 2, 4, 7-9) Endpoints are captured at baseline, month 4, month 8, annual visits (month 12, 24, 36, 48, 60, 72), telephone contacts, brief visits (month 18, 30, 42, 54, 66), end of study, and post-study phone contact

    (3) Mortality: Date of death from any cause captured per patient

    (5) HbA1c: captured at baseline, month 4, month 8, annual visits (month 12, 24, 36, 48, 60, 72) and end of study

    (6) eGFR: captured at baseline, annual visits (month 12, 24, 36, 48, 60, 72), brief visits (month 18, 30, 42, 54, 66), and end of study
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 trial1
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA290
    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
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    Estonia
    European Union
    Finland
    France
    Germany
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Netherlands
    Norway
    Poland
    Romania
    Russian Federation
    Singapore
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Turkey
    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
    LVLS
    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 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: 6557
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8200
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5539
    F.4.2.2In the whole clinical trial 14757
    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)
    SOC
    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 Decision2011-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-30
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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