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    Summary
    EudraCT Number:2016-003614-27
    Sponsor's Protocol Code Number:GIA-DAP-16-005
    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:2018-02-08
    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 number2016-003614-27
    A.3Full title of the trial
    Study on the effect of dapagliflozin on myocardial insulin sensitivity and perfusion (DapaHeart)
    Study on the effect of dapagliflozin on myocardial insulin sensitivity and perfusion (DapaHeart)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ND
    ND
    A.3.2Name or abbreviated title of the trial where available
    DAPA HEART
    DAPA HEART
    A.4.1Sponsor's protocol code numberGIA-DAP-16-005
    A.5.4Other Identifiers
    Name:NDNumber:ND
    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 SponsorUNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI
    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 supportASTRAZENECA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCLINICAL TRIAL CENTER
    B.5.2Functional name of contact pointCRO ACCADEMICA
    B.5.3 Address:
    B.5.3.1Street AddressLARGO AGOSTINO GEMELLI, 8
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0688805566
    B.5.5Fax number0688805567
    B.5.6E-mailbetty.polikar@policlinicogemelli.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 FORXIGA - 10 MG - COMPRESSE RIVESTITE CON FILM- USO ORALE - BLISTER CALENDARIZZATO (ALU/ALU) - 30X1 COMPRESSA (DOSE UNITARIA)
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL- MYERS SQUIBB/ASTRAZENECA EEIG
    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.3.1Product nameFORXIGA
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDAPAGLIFLOZIN
    D.3.9.2Current sponsor codeND
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 placeboFilm-coated tablet
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    TYPE 2 DIABETES
    DIABETE TIPO 2
    E.1.1.1Medical condition in easily understood language
    ND
    ND
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10027433
    E.1.2Term Metabolism and nutrition disorders
    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 is to assess the effect of dapagliflozin on myocardial insulin sensitivity.
    L'obiettivo primario è quello di valutare l'effetto di Dapagliflozina sull'insulino-sensibilità miocardica.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the global heart function, the metabolic systemic effects of dapagliflozin, and the glycemic control.
    Inoltre, verranno valutati gli effetti di Dapagliflozina sulla funzione complessiva cardiaca, sulla sensibilità insulinica sistemica e sul controllo glicemico complessivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Female or male subjects aged between 40 and 75 inclusive.
     Patients who have been surgically sterilized (hysterectomy or tubal-ligation) at least 12 months prior to screening, or
     are postmenopausal having had no regular menstrual bleeding for at least one (1) year prior to screening. Menopause will be confirmed by a plasma follicle stimulating hormone (FSH) level of > 35 IU/mL at screening, or
     Women with childbearing potential willing not to start a pregnancy during the course of the study and non-nursing women
     Men having relationships with women with childbearing potential willing not to procure a pregnancy during the course of the study;
    3. Patients with type 2 diabetes
    4. Patients with established, stable CAD, defined as ≥30% coronary stenosis in at least one major coronary vessel on invasive coronary angiography (ICA) or computed tomography angiography (CTA) performed within 12 months from screening and no indication to revascularization
    5. Patients with a clinical indication for 13N-ammonia PET-CT, as established by a cardiologist, nuclear medicine physician or diabetologists
    6. Patients with a body mass index (BMI) equal or greater than 25 kg/m2 but less than 35 kg/m2 [BMI = Weight (kg) / Height squared (m2)]
    7. Patients with a HbA1c between 7,5% and 8,5% according to the actual clinical conditions of the patients;
    8. Patients with a diabetes duration <10 years;
    9. Patients with stable medical therapy [including other anti-hyperglycemic agents (see Table 1, section 5.2.1 for all therapies allowed, as per current standard treatment); pioglitazone and basal-bolus insulin treatment are excluded, as reported in the exclusion criteria 15] for at least 3 months prior to the screening visit (including stable insulin dose defined as no variation more than 30% in daily insulin dose within the preceding 3 months,. The reference for the initial prescription of the insulin dose starts from the values described in Table 1, section 5.2.1,. and is then titrated on the metabolic assessment done for each patient).
    10. Patients with Fasting C-peptide > 1 ng/mL (0.33 nmol/L) at Visit 0
    1. Consenso Informato firmato e datato dal paziente, prima di iniziare qualsiasi procedura prevista dallo studio
    2. Soggetti di sesso femminile o maschile di età compresa tra i 40 e i 75 anni• Pazienti di sesso femminile che sono state chirurgicamente sterilizzate (isterectomia o legatura delle tube) almeno 12 mesi prima della visita di screening, o
    • sono in post-menopausa, in assenza di ciclo mestruale regolare da almeno un (1) anno prima della visita di screening. La menopausa sarà confermata da un livello di ormone follicolo plasma stimolante (FSH) di> 35 UI / ml alla visita di screening, o
    • Le donne in età fertile che sono disposte a non iniziare una gravidanza durante il corso dello studio e/o in allattamento
    • Uomini che hanno una relazione con donne in età fertile che sono disposti a non procurare una gravidanza durante il corso dello studio 3. diabete mellito di tipo 2
    4. malattia coronarica stabile, definita come stenosi coronariche ≥30% in almeno uno dei principali vasi coronarici su coronarografia invasiva o mediante angiografia tomografica computerizzata effettuata entro 12 mesi dallo screening e con nessuna indicazione alla rivascolarizzazione
    5. indicazione clinica per eseguire PET-CT con 13N-ammoniaca, come da indicazione di cardiologo, medico di medicina nucleare o diabetologo
    6. indice di massa corporea (BMI) uguale o superiore a 25 kg/m2, ma inferiore a 35 kg/m2 [BMI = peso (kg)/altezza al quadrato (m2)]
    7. emoglobina glicata tra 7,5%, e 8,5%, secondo in base alla classe di rischio del paziente
    8. durata del diabete <10 anni
    9.Pazienti con terapia medica stabile (compresi gli altri agenti anti-iperglicemici, ad eccezione di pioglitazone e trattamento con insulina secondo schema basal-bolus) per almeno 3 mesi prima della visita di screening (compresa dose stabile di insulina definita come variazione non superiore al 30% della dose giornaliera di insulina nei precedenti 3 mesi, a giudizio dello sperimentatore). Il riferimento dei valori per la prescrizione iniziale della dose di insulina è descritto nella Tabella 1, sezione 5.2.1 e viene poi modulata sulla valutazione metabolica eseguita per ogni paziente)
    10. C-peptide> 1 ng/mL (0,33 nmol / L), a digiuno, alla Visita di screening
    E.4Principal exclusion criteria
    1. Type 1 diabetes (as assessed by medical history); previous diagnosis of Latent Autoimmune Diabetes of Adults (LADA), and or not fulfilling inclusion criteria #10
    2. History of diabetic ketoacidosis or hyperosmolar non ketotic coma
    3. NYHA class III or IV
    4. Unstable angina
    5. Previous re-vascularisation (either percutaneous coronary intervention or coronary artery bypass graft)
    6. Reduced left ventricular ejection fraction (≤50%)
    7. Increased likelihood of developing diabetic ketoacidosis (history of DKA, alcohol consumption, volume depletion dehydration, clinical conditions causing diarrhea, vomit and anorexia)
    8. Moderate to severe renal impairment (eGFR<60 ml/min/1.73m2 as calculated by the modification of diet in renal disease [MDRD] equation or end-stage renal disease); overt proteinuria, defined as Spot urine Microalbumin/Cr ratio of >300 mg/g at screening (Visit 0)
    9. Severe liver dysfunction
    10. Asthma
    11. Uncontrolled blood pressure
    12. Symptomatic tachy- or bradyarrhythmias
    13. Previous acute myocardial infarction
    14. Contraindications to adenosine: known hypersensitivity to adenosine or to any of the excipients; sick sinus syndrome, second or third degree atrio-ventricular block (except in patients with a functioning artificial pacemaker); chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma bronchiale); long QT syndrome; severe hypotension; decompensated states of heart failure
    15. Use of pioglitazone; use of loop diuretics; basal-bolus insulin therapy; use of systemic steroids less than 3 days prior to the screening visit (Visit 0)
    16. Known hypersensitivity to the active substance or to any of the excipients in study drug
    17. Inability to provide informed consent
    18. Participation in another clinical study with an investigational product during the previous 30 days
    19. Patients with history of breast, bladder and prostate cancer
    20. Patients will undergo to surgical procedures
    21 Patients with acute urinary tract infection
    22 Patients with history of intolerance to galactose and lactose
    23. Severe/uncontrolled medical conditions, causing volume depletion
    1. Diabete di tipo 1 (valutato mediante anamnesi) o diagnosi pregressa di Diabete Autoimmune dell’Adulto (LADA), e/o in caso di non rispondenza al criterio di inclusione #10
    2. storia di chetoacidosi diabetica o coma iperosmolare non-chetosico;
    3. classe NYHA III o IV;
    4. angina instabile;
    5. pregressa rivascolarizzazione (o intervento coronarico percutaneo o bypass coronarico);
    6. ridotta frazione di eiezione ventricolare sinistra (≤50%)
    7. maggior rischio di sviluppare chetoacidosi diabetica (storia di coma iperosmolare chetosico, consumo di alcol, deplezione di volume, disidratazione, condizioni cliniche che determinano vomito, diarrea e anoressia)
    8. insufficienza renale da moderata a grave (eGFR <60 ml/min/1,73m2 come calcolato dalla mediante formula MDRD o stadio terminale della malattia renale); Proteinuria franca, definita come microalbuminuria > 300 mg/g allo screening
    9. insufficienza epatica grave
    10. asma bronchiale
    11. ipertensione arteriosa non controllata
    12. tachicardia sintomatica o bradiaritmie
    13. precedente infarto miocardico acuto
    14. controindicazioni all'adenosina: nota ipersensibilità all’adenosina o ad uno qualsiasi degli eccipienti; sick sinus syndrome, blocco atrio-ventricolare di secondo o terzo grado (ad eccezione dei pazienti con pacemaker funzionante); malattia polmonare cronica ostruttiva con evidenza di broncospasmo (ad esempio asma bronchiale); sindrome del QT lungo; ipotensione grave; insufficienza cardiaca scompensata
    15. uso di pioglitazone; uso di diuretici dell'ansa; terapia insulinica multiniettiva secondo schema basal-bolus; uso di steroidi sistemici meno di 3 giorni prima della visita di screening
    16. iIpersensibilità al principio attivo o ad uno qualsiasi degli eccipienti del farmaco in studio
    17. incapacità di fornire il consenso informato
    18. partecipazione a un altro studio clinico con un prodotto in sperimentazione negli ultimi 30 giorni
    19. pazienti con storia di neoplasia a carico di mammella, vescica o prostata
    20. pazienti che verranno sottoposti a procedure chirurgiche
    21. pazienti con infezione acuta del tratto urinario
    22. pazienti con storia di intolleranza al galattosio e/o lattosio
    23. gravi e instabili condizioni cliniche che causano deplezione di volume
    E.5 End points
    E.5.1Primary end point(s)
    myocardial glucose uptake (MGU)
    uptake di glucosio miocardico
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 MONTHS
    15 MESI
    E.5.2Secondary end point(s)
    • Myocardial perfusion
    • Systemic insulin sensitivity
    • Pericardial fat
    • Glycemic control
    • Cardiac function
    • Body weight
    • Blood pressure
    • Urinary output
    • Urinary glucose output
    • perfusione miocardica
    • sensibilità insulinica periferica
    • grasso pericardico
    •controllo glicemico
    •funzione cardiaca
    • peso corporeo
    • pressione arteriosa
    • escrezione urinaria
    • glicosuria
    E.5.2.1Timepoint(s) of evaluation of this end point
    15 MONTHS
    15 MESI
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    CLINICAL STUDY REPORT AVAIABILITY
    DISPONIBILITA' DEL CLINICAL STUDY REPORT
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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: 1
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-02-08. Yes
    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 state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 52
    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)
    NORMAL CLINICAL PRACTICE
    NORMALE PRATICA CLINICA
    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 Decision2017-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-20
    P. End of Trial
    P.End of Trial StatusOngoing
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