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    Summary
    EudraCT Number:2015-004164-11
    Sponsor's Protocol Code Number:DAPA-BP
    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:2019-02-25
    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 number2015-004164-11
    A.3Full title of the trial
    Effect of dapagliflozin on flow-mediated dilation and blood pressure (DAPA-BP): a phase III, randomized, open-label, parallel group study in hypertensive patients with controlled type 2 diabetes
    Studio clinico di fase III randomizzato in aperto, controllato, a due bracci paralleli, per valutare l’effetto di Dapagliflozin sulla flow-mediated dilation e la pressione arteriosa in pazienti ipertesi con diabete mellito di tipo 2 ben controllato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of the glucose-lowering drug dapagliflozin on vascular function and blood pressure
    Effetto dell’antidiabetico orale dapagliflozin sulla funzione vascolare e sulla pressione arteriosa
    A.3.2Name or abbreviated title of the trial where available
    DAPA
    DAPA
    A.4.1Sponsor's protocol code numberDAPA-BP
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
    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 S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA OSPEDALIERO UNIVERSITARIA PISANA
    B.5.2Functional name of contact pointU.O. MEDICINA INTERNA III
    B.5.3 Address:
    B.5.3.1Street Addressc/o OSPEDALE S. CHIARA, edificio 43 - VIA ROMA 67
    B.5.3.2Town/ cityPISA
    B.5.3.3Post code56100
    B.5.3.4CountryItaly
    B.5.4Telephone number050-993482
    B.5.5Fax number050-993482
    B.5.6E-mailanna.solini@med.unipi.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) - 28 COMPRESSE
    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.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeNON DISPONIBILE
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 ESIDREX - 25 MG COMPRESSE 20 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA S.P.A.
    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 nameESIDREX
    D.3.2Product code NON DISPONIBILE
    D.3.4Pharmaceutical form 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 INNIDROCLOROTIAZIDE
    D.3.9.1CAS number 58-93-5
    D.3.9.2Current sponsor codeNON DISPONIBILE
    D.3.9.3Other descriptive nameIDROCLOROTIAZIDE
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Arterial hypertension
    Ipertensione arteriosa
    E.1.1.1Medical condition in easily understood language
    Arterial hypertension
    Ipertensione arteriosa
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020775
    E.1.2Term Hypertension arterial
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Aim of this project will be to evaluate the effect short-term (4 weeks) administration of dapagliflozin as compared to a thiazide diuretic on endothelial function as flow mediated dilation (FMD) of the brachial artery.
    Valutare la variazione della funzione endoteliale dell’arteria brachiale, misurata come flow mediated dilation (FMD) dopo 4 settimane di terapia con dapagliflozin o idroclorotiazide (studio principale “short term”)
    E.2.2Secondary objectives of the trial
    a) To assess the effects of short-term (4 weeks) treatment period with the two treatments on the following parameters:
    • Renal Resistive Index (RRI) before and after nitrate administration
    • Endothelial function as flow mediated dilation (FMD) of brachial artery
    • Carotid to femoral pulse wave velocity
    • Peripheral and Central BP measurement
    • 24h BP monitoring
    • 24h urinary albumin excretion
    • 24h diuresis for glucose, Na, K, Cl, Ca, Mg urinary excretion determination
    • Free water clearance and Na fractional excretion
    • PRA, aldosterone, catecholamines plasma levels
    • Daily glucose profile (7 determination in a day)
    Safety objective
    • Adverse events and adverse drug reactions
    • Estimated glomerular filtration rate (eGFR) (based on CKD-EPI formula starting from serum creatinine)
    • Routine laboratory parameters (haematology, blood chemistry and urinalysis).
    a) Valutare la variazione dopo 4 settimane (studio principale “short term”) di terapia con i due trattamenti dei seguenti parametri :
    • indici di resistività intraparenchimale renale (RRI) prima e dopo somministrazioni di nitrati
    • velocità dell’onda di polso carotido-femorale
    • pressione arteriosa clinica e centrale
    • pressione aretriosa monitorata delle 24 ore
    • escrezione urinaria delle 24 ore di albumina
    • escrezione urinaria delle 24 ore di Na, K, Cl, Ca, Mg
    • clearance dell’acqua libera, escrezione frazionata di sodio
    • PRA, aldosterone e catecolamine plasmatiche
    • marcatori plasmatici di stress ossidativo e attivazione e danno endoteliale
    • profilo glicemico giornaliero (7 determinazioni giornaliere).
    Obiettivi di sicurezza:
    • eventi avversi, reazioni avverse al farmaco
    • funzione renale (filtrazione glumerulare stimata, eGFR, basata sulla cretatininemia e la formula CKD-EPI)
    • esami ematochimici e urinari di routine (emocromo, biochimica clinica e analisi delle urine).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    TITLE: Acute study
    DATE 14-09-2015
    VERSION 1.4
    OBJECTIVES:
    b) To evaluate the effect of acute (2 days) administration of dapagliflozin on:
    • Endothelial function as flow mediated dilation (FMD) of brachial artery
    • Renal Resistive Index (RRI) before and after nitrate
    • Carotid to femoral pulse wave velocity
    • Peripheral and Central BP measurement
    • 24h diuresis for glucose, K, Cl, Ca, Mg urinary excretion determination
    • Free water clearance and Na fractional excretion
    • PRA, aldosterone, catecholamines plasma levels
    • Daily glucose profile (7 determinations in a day)
    TITOLO: Acute study
    DATA 14-09-2015
    VERSIONE 1.4
    OBIETTIVI:
    b) Valutare la variazione acuta (sotto-studio “acute”) dopo 2 giorni di terapia con dapagliflozin dei seguenti parametri:
    • funzione endoteliale dell’arteria brachiale, misurata come flow mediated dilation (FMD)
    • indici di resistività intraparenchimale renale (RRI) prima e dopo somministrazioni di nitrati
    • velocità dell’onda di polso (PWV) carotido-femorale
    • pressione arteriosa clinica e centrale
    • escrezione urinaria delle 24 ore di Na, K, Cl, Ca, Mg
    • clearance dell’acqua libera, escrezione frazionata di sodio
    • PRA, aldosterone e catecolamine plasmatiche
    • profilo glicemico giornaliero (7 determinazioni giornaliere)
    E.3Principal inclusion criteria
    Inclusion criteria for the main study (short-term study):
    1. Provision of informed consent prior to any study specific procedures
    2. Men or post-menopausal women that express their willing to participate in the study by signing the informed consent
    3. Subjects aged 30-69 years (inclusive)
    4. T2DM patients with adequate glucose control (HbA1c<7.5%), achieved with any oral anti-hyperglycemic treatment, whose BP values are not at target (e.g. clinic BP >140/90 mmHg or home BP >135/85 mmHg despite a therapeutic dose of ACE-inhibitors
    Inclusion criteria for the substudy (acute study):
    1. Provision of informed consent prior to any study specific procedures
    2. Men or post-menopausal women that express their willing to participate in the study by signing the informed consent
    3. Subjects aged 30-69 years (inclusive)
    4. T2DM patients with adequate glucose control (HbA1c<7.5%) achieved with any oral anti-hyperglycemic treatment, but treatment-naïve for hypertension whose blood pressure values are not controlled (e.g. clinic BP >140/90 mmHg or home BP >135/85 mmHg), in whose according to guidelines antihypertensive treatment is not yet compelling
    Criteri di inclusione (Studio principale, “Short term”):
    1. Firma del consenso informato prima di qualsiasi procedura specifica facente parte dello studio;
    2. Uomini o donne in post-menopausa che esprimano la loro volontà di partecipare allo studio;
    3. Età compresa tra 30 e 69 anni (inclusi);
    4. Pazienti con diabete mellito tipo 2 con controllo glicemico adeguato (HbA1c<7.5%) ottenuto con qualsiasi terapia antidiabetica, e ipertensione arteriosa con valori pressori non controllati (pressione arteriosa clinica >140/90 mmHg o domiciliare >135/85 mmHg) nonostante il trattamento con un ACE-inibitore dose a dosaggio adeguato.
    Criteri di inclusione (sotto-studio, “Acute”):
    1. Firma del consenso informato prima di qualsiasi procedura specifica facente parte dello studio;
    2. Uomini o donne in post-menopausa che esprimano la loro volontà di partecipare allo studio;
    3. Età compresa tra 30 e 69 anni (inclusi);
    4. Pazienti con diabete mellito tipo 2 con controllo glicemico adeguato (HbA1c<7.5%), e ipertensione arteriosa con valori pressori non controllati (pressione arteriosa clinica >140/90 mmHg o domiciliare >135/85 mmHg), mai trattati con farmaci antiipertensivi, in cui tale trattamento non è ancora obbligatorio in accordo con le linee guida
    E.4Principal exclusion criteria
    • Clinic BP values > 160/100 mmHg
    • eGFR<60ml/min/1.73 m2
    • Patients with NYHA III/IV heart failure
    • Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
    • Total bilirubin >2.0 mg/dL (34.2 µmol/L)
    • Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
    • Volume depleted patients or those who, in the judgement of the investigator, may be at risk for dehydration (use of other diuretics, laxatives, chronic diarrhoea etc)
    • History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin cancer
    • Patients unable to give a valid informed consent;
    • Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
    • Patients who received any investigational new drug within the last 12 weeks;
    • Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
    • Pressione arteriosa clinica > 160/100 mmHg;
    • Stima del filtrato glomerulare (eGFR)<60ml/min/1.73 m2;
    • Pazienti con insufficienza cardiaca classe NYHA III/IV;
    • Insufficienza epatica severa o alterazioni significative della funzione epatica, definite come aspartato aminotrasferasi (AST) >3x il limite superiore di noormalità (upper limit of normal - ULN) e/o alanina aminotrasferasi (ALT) >3x ULN;
    • Bilirubina totale >2.0 mg/dL (34.2 µmol/L);
    • Evidenzia sierologica di epatite virale, definite come Anticorpi AntiHBV IgM, HBsAg, anticorpi AntiHCV;
    • Pazienti disidratati o a rischio di disidratazione secondo il giudizio clinico (uso di altri diuretici o lassativi, diarrea, ecc);
    • Neoplasia negli ultimi 5 anni, escluso carcinoma cutaneo squamoso o basocellulare trattato con successo;
    • Pazienti non in grado di fornire un valido consenso informato;
    • Pazienti con scarsa probabilità di aderire al protocollo di studio o incapaci di capire la natura, gli scopi e le possibili conseguenze dello studio;
    • Pazienti che hanno ricevuto un qualsiasi trattamento sperimentale nelle ultime 12 settimane;
    • Dipendenti del Centro sperimentatore (sperimentatore principale, altri sperimentatori, coordinator dello studio, altro personale dipendente o a contratto) che abbiano coinvolgimento diretto nello studio proposto o in altri studi sotto la direzione dello stesso sperimentatore o dello stesso centro; familiari di dipendenti del Centro o degli sperimentatori.
    E.5 End points
    E.5.1Primary end point(s)
    Change in endothelial function of the brachial artery, measured as flow mediated dilation (FMD), after 4-week administration of dapagliflozin or hydrochlorothiazide (short-term study).
    Variazione della funzione endoteliale dell’arteria brachiale, misurata come flow mediated dilation (FMD) dopo 4 settimane di terapia con dapagliflozin o idroclorotiazide (studio principale “short term”)
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 WEEKS
    4 SETTIMANE
    E.5.2Secondary end point(s)
    Safety endpoints (adverse events and adverse drug reactions: eGFR haematology and blood chemistry laboratory parameters and urinalysis).
    7) Obiettivi di sicurezza (eventi avversi, reazioni avverse al farmaco, funzione renale, esami ematochimici e urinari di routine).
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 WEEKS
    4 SETTIMANE
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 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) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 55
    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)
    Patients continue with the assistance programs provided by the clinical practice.
    I pazienti proseguiranno con i programmi assistenziali previsti dalla 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 Decision2015-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-05
    P. End of Trial
    P.End of Trial StatusOngoing
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