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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-006719-20
    Sponsor's Protocol Code Number:0431-082
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-27
    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 ConcernedSpain - AEMPS
    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 on Mono- or Dual Combination Oral Antihyperglycemic Therapy
    TECOS: Ensayo clínico aleatorizado y controlado con placebo para evaluar los sucesos cardiovasculares tras el tratamiento con sitagliptina en pacientes con diabetes mellitus de tipo 2 y control glucémico inadecuado con monoterapia o biterapia antidiabética oral
    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 Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck & Co., Inc.
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 25 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP AND DOHME LTD.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSITAGLIPTINA FOSFATO MONOHIDRATO
    D.3.9.1CAS number 790712-60-6
    D.3.9.2Current sponsor codeMK-0431
    D.3.9.3Other descriptive nameSITAGLIPTINA FOSFATO MONOHIDRATO
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 100 mg, comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP AND DOHME LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSITAGLIPTINA FOSFATO MONOHIDRATO
    D.3.9.3Other descriptive nameSITAGLIPTINA FOSFATO MONOHIDRATO
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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)

    Diabetes Mellitus tipo 2 (T2DM)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    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 cardiovascular (CV) outcomes as measured by the primary CV composite endpoint of CV-related death, nonfatal myocardial infarction (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) A secondary composite CV endpoint of CV-related death, nonfatal MI, and nonfatal stroke
    (2) Each of the components of the primary composite endpoint
    (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 (based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method) and albuminuria (based on urinary albumin to creatinine ratio) over time
    (7) 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) Time to addition of first co-interventional agent
    (9) Medical resource utilization during the trial
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic analysis = included in the Main Protocol

    Objectives:
    To investigate the relationships between genetic make-up and clinical events.
    The genetic analysis performed as part of this study may identify genetic loci that associate with cardiovascular outcomes in patients with T2DM or loci that associate with response to sitagliptin.
    E.3Principal inclusion criteria
    a. Patient has T2DM and has not previously required insulin other than for a short term, reversible illness (less than three consecutive months of insulin use), or during
    pregnancy.
    b. Patient is able to see a usual care provider at least twice a year
    c. Patient is receiving metformin, pioglitazone, or a sulfonylurea as monotherapy or any dual combination of metformin, pioglitazone, or a sulfonylurea continuously for at
    least 3 months without dose alterations, and has an HbA1c of ? 6.5% and ? 8.0%
    (HbA1c must be documented within 3 months prior to study enrollment). Patients whose HbA1c is > 8.0% may, at the discretion of the investigator, have their oral AHA therapy adjusted and be re-screened for randomization eligibility (HbA1c of ? 6.5% and ? 8.0%) following a 3-month period on a stable AHA dose.
    d. Patient is ? 50 years of age with preexisting vascular disease, defined as having any one of the following:
    - 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);
    - Ischemic cerebrovascular disease, including:
    o History of ischemic stroke. Strokes not known to be hemorrhagic will be allowed as part of this criterion;
    o 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.
    - 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.
    e. Female patients agree to use an effective method of contraception or must not
    otherwise be at risk of becoming pregnant.
    f. 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.
    g. 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, a history of ketoacidosis, or is
    currently taking insulin.
    b. Patient has taken an approved or investigational DPP-4 inhibitor agent (e.g., sitagliptin, alogliptin, saxagliptin, or vildagliptin), GLP-1 analogues (e.g., exenatide,
    exenatide LAR, or liraglutide), or a thiazolidinedione other than pioglitazone within
    the past 3 months.
    c. Patient has cirrhosis of the liver, as assessed by medical history.
    d. 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.
    e. Patient has a planned or anticipated revascularization procedure.
    f. Pregnancy or planned pregnancy during the trial period.
    g. 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.
    h. Patient has a history or current evidence of any condition, therapy, lab bnormality, 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.
    i. Patient has an estimated GFR (calculated based on serum creatinine via the MDRD
    formula [10]) of < 30 mL/min/1.73 m2.
    j. Patient has a known allergy or intolerance to sitagliptin.
    k. Patient has previously been enrolled in this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Primary CV composite endpoint consists of CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization. Primary efficacy endpoint is time to first confirmed CV event 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.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 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 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.8.3 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 EEA142
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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.1.1.1In 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.1.3Elderly (>=65 years) Yes
    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 state210
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4631
    F.4.2.2In the whole clinical trial 14000
    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 Decision2009-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-06
    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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