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    Summary
    EudraCT Number:2012-005427-32
    Sponsor's Protocol Code Number:MeMeMe
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-07-09
    Trial 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 number2012-005427-32
    A.3Full title of the trial
    Randomized controlled trial of metformin and dietary restriction to prevent age-related morbid events in people with metabolic syndrome
    Sperimentazione controllata randomizzata di restrizione calorica e metformina per prevenire patologie età-correlate in persone con sindrome metabolica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of chronic diseases through diet and metformin
    Studio sulla prevenzione delle malattie croniche attraverso la dieta e il trattamento con metformina
    A.3.2Name or abbreviated title of the trial where available
    MeMeMe
    MeMeMe
    A.4.1Sponsor's protocol code numberMeMeMe
    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 SponsorFondazione IRCCS Istituto Nazionale dei Tumori
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Research Council
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale dei Tumori
    B.5.2Functional name of contact pointSC Epidemiologia e Prevenzione
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezian, 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number390223903515
    B.5.5Fax number390223903516
    B.5.6E-mailfranco.berrino@istitutotumori.mi.it
    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 GLUCOPHAGE
    D.2.1.1.2Name of the Marketing Authorisation holderBruno Farmaceutici SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNNA
    D.3.9.1CAS number 1115-70-4
    D.3.9.2Current sponsor codeMeMeMe
    D.3.9.3Other descriptive nameMETFORMIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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 placeboTablet
    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
    metabolic syndrome
    sindrome metabolica
    E.1.1.1Medical condition in easily understood language
    Metabolic syndrome, characterized by abdominal obesity, hypertension, high plasma glucose, high triglycerides, and low HDL cholesterol
    sindrome metabolica, caratterizzata da obesità addominale, ipertensione, glicemia alta, trigliceridi alti, e basso livello di colesterolo buono (HDL)
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to evaluate the effect of a comprehensive life-style intervention (including moderate physical activity and Mediterranean/macrobiotic diet with moderate calorie and protein restriction), and of treatment with Metformin (a calorie restriction mimetic drug) for the prevention of age-related chronic diseases
    L’obiettivo dello studio è di valutare gli effetti di un intervento volto a far cambiare lo stile di vita (con un programma comprendente moderata attività fisica e dieta Mediterranea/macrobiotica per ottenere una moderata restrizione calorica e proteica), e o di un trattamento con metformina (un farmaco mimetico di restrizione calorica) sulla prevenzione delle patologie croniche legate all’età.
    E.2.2Secondary objectives of the trial
    Evaluate the effect of the intervention on total mortality and on the incidence of specific chronic diseases (diabetes, myocardial infarction, stroke, cancers, and others).
    Valutare l’impatto dell’intervento sulla mortalità totale e sull’incidenza di specifiche patologie croniche (diabete, infarto cardiaco, ictus cerebrale, tumori e altre)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 55-74, waist circumference equal or greater than 85 cm for women and 100 cm for men, plus at least two other factors among those defining the metabolic syndrome.
    Età 55-74, circonferenza vita maggiore o uguale a 85 cm per le donne e 100 cm per gli uomini, più almeno altri due fattori fra quelli che definiscono la sindrome metabolica
    E.4Principal exclusion criteria
    -Dignosed diabetes (or baseline fasting glycemia above 7 mmol/L) at baseline examination - cancer (except skin carcinoma) diagnosed in the last 5 years, or under treatment. -Excessive frailty: in absence of agreed-upon measurements parameters and cutoff points, we will exclude subjects under the lower 5th percentile of the muscular mass distribution estimated by impedance in previous studies. - Conditions that controindicate the use of MET because may favour lactic acidosis: Renal, cardiac, hepatic, or respiratory insufficiency, serum creatinine > 124 µmol/L, or proteinuria. Curent treatment with K-sparing diuretics, or with proton pump inhibitors. Excessive alcohol consumption. -Distressing side effects of MET treatment, such as nausea and diarrhoea.
    - Diagnosi di diabete (o glicemia basale a digiuno superiore a 7mmol/L)
    -diagnosi di cancro (eccetto epiteliomi cutanei) negli ultimi 5 anni o in corso di trattamento
    - eccessiva debolezza, con massa magra impedenziometrica inferiore al 5° percentile
    - Condizioni che controindicano l’uso di metformina in quanto potrebbero favorire l’acidosi lattica: insufficienza renale, cardiaca, epatica o respiratoria. Creatinina sierica >124 µmol/L, o proteinuria. Trattamento con diuretici risparmiatori di potassio o con inibitori della pompa protonica. Eccessivo consumo di alcol
    - Effetti collaterali fastidiosi della metformina tipo nausea e/o diarrea
    E.5 End points
    E.5.1Primary end point(s)
    Total incidence of age related chronic diseases. We will retrieve records for all Age related chronic diseases but we will first concentrate the analysis on cancer, coronary heart disease, stroke, and diabetes
    Incidenza complessiva di malattie croniche legate all’età. Registreremo l’incidenza di tutte le patologie ma ci concentreremo prioritariamente su diabete, malattie cardiovascolari, tumori maligni.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 years
    5 anni
    E.5.2Secondary end point(s)
    Total mortality and incidence of specific chronic diseases
    Mortalità totale e incidenza di specifiche malattie croniche
    E.5.2.1Timepoint(s) of evaluation of this end point
    A longer follow-up, of the order of 8-10 years will be necessary to analyse the incidence of specific chronic diseases
    Una sufficiente potenza statistica per esaminare specifiche patologie richiederà un follow-up più prolungato, dell'ordine di 8-10 anni.
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    prevention of age related chronic diseases.
    prevenzione delle malattie croniche legate all'età.
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    disegno fattoriale con metformina versus placebo in doppio cieco e dieta e attività fisica in aperto
    factorial randomization by metformin/placebo, diet physical activity/not diet Physical activity
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    dieta versus raccomandazioni
    Diet versus recommendations
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    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
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state2000
    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)
    Reiteration of the lifestyle recommendations
    Reiterazione delle raccomandazioni di stile di vita
    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 Decision2014-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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