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    Summary
    EudraCT Number:2018-000832-82
    Sponsor's Protocol Code Number:GLYCEMIA-Heart
    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:2019-06-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-000832-82
    A.3Full title of the trial
    GLYcemic Control with EMpagliflozin vs standard of care in patients with type 2 dIAbetes and Heart failure: effects on cardiac remodeling and neurohormonal activation
    EFFETTI DI EMPAGLIFLOZIN SU RIMODELLAMENTO
    CARDIACO E ATTIVAZIONE NEUROORMONALE IN PAZIENTI CON DIABETE MELLITO TIPO 2 E SCOMPENSO CARDIACO CRONICO. UNO STUDIO PROSPETTICO, MONOCENTRICO, RANDOMIZZATO, INTERVENTISTICO, IN APERTO, DI FASE IV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GLYcemic Control with EMpagliflozin vs standard of care in patients with type 2 dIAbetes and Heart failure: effects on cardiac remodeling and neurohormonal activation
    EFFETTI DI EMPAGLIFLOZIN SU RIMODELLAMENTO
    CARDIACO E ATTIVAZIONE NEUROORMONALE IN PAZIENTI CON DIABETE MELLITO TIPO 2 E SCOMPENSO CARDIACO CRONICO. UNO STUDIO PROSPETTICO, MONOCENTRICO, RANDOMIZZATO, INTERVENTISTICO, IN APERTO, DI FASE IV
    A.3.2Name or abbreviated title of the trial where available
    GLYCEMIA-Heart
    GLYCEMIA-Heart
    A.4.1Sponsor's protocol code numberGLYCEMIA-Heart
    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 TOSCANA GABRIELE MONASTERIO
    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 supportFondazione Toscana Gabriele Monasterio
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Toscana Gabriele Monasterio
    B.5.2Functional name of contact pointU.O.C. Farmaceutica Ospedaliera
    B.5.3 Address:
    B.5.3.1Street AddressVia Aurelia Sud
    B.5.3.2Town/ cityMassa
    B.5.3.3Post code54100
    B.5.3.4CountryItaly
    B.5.4Telephone number0585493507
    B.5.5Fax number0585493508
    B.5.6E-mailfarmacisti@ftgm.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 JARDIANCE - 10 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL GMBH
    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 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 INNempagliflozin
    D.3.9.2Current sponsor codeempagliflozin
    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 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 JARDIANCE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL GMBH
    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 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 INNempagliflozin
    D.3.9.2Current sponsor codeempagliflozin
    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
    Heart failure and type 2 diabetes mellitus
    Scompenso cardiaco e Diabete mellito di tipo II
    E.1.1.1Medical condition in easily understood language
    Heart failure and type 2 diabetes mellitus
    Scompenso cardiaco e Diabete mellito di tipo II
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10063624
    E.1.2Term Type II diabetes mellitus inadequate control
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007554
    E.1.2Term Cardiac failure
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Test the effects of empagliflozin on neuro-hormonal activation, as exstimated by 1-year variation in NT-proBNP plasma concentrations
    Verificare gli effetti di empagliflozin sullo stato di attivazione neuroormonale, valutato attraverso la variazione a un anno delle concentrazioni circolanti di NT-proBNP
    E.2.2Secondary objectives of the trial
    - Test the effects of empagliflozin on left ventricular remodeling, defined as variations in endsystolic and end-diastolic left ventricular volumes at 1-year transthoracic echocardiographic follow-up.
    - Test the effects of empagliflozin on adrenergic and renin-angiotensin-aldosterone systems activation.
    - Test the effects of empagliflozin on exercise capacity, measured as peak oxygen consumption at cardiopulmonary test.
    - Verificare gli effetti di empagliflozin sul rimodellamento ventricolare sinistro, definito come variazione a un anno dei volumi telediastolico e telesistolico ventricolare sinistro all’ecocardiogramma transtoracico;
    - Verificare gli effetti di empagliflozin sul grado di attivazione del sistema reninaangiotensina- aldosterone e del sistema adrenergico;
    - Verificare gli effetti di empagliflozin sulla capacità funzionale, espressa come consumo di ossigeno al picco del test cardiopolmonare.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of type 2 diabetes mellitus with HbA1c ≥7.0% and ≤10.0%, on stable pharmacological therapy for at least one month;
    - Heart failure (diagnosed according to Framingham criteria) with left ventricular dysfunction (defined as left ventricular ejection fraction - EF <50%), New York Heart Association (NYHA) classes II-IV;
    - Stable therapy with ACEi/ARBs, beta-blockers and, when indicated, with aldosterone receptor antagonist and sacubitril/valsartan (in patients not treated with ACEi/ARBs) for at least one month;
    - Plasma levels of NT-proBNP ≥600 ng/L
    - Age ≥ 18 years;
    - Exstimated Glomerular Filtration Rate (evaluated with MDRD formula) ≥60 ml/min/1,73m2;
    - Informed Consent signature.
    - Diagnosi di DMT2 con valori di HbA1c ≥7,0% e ≤10,0%, in terapia stabile da almeno un mese;
    - Diagnosi di scompenso cardiaco (in accordo con i criteri di Framingham) in classe NYHA II-IV con evidenza di disfunzione sistolica ventricolare sinistra, definita come frazione di eiezione (FE) <50% a un ecocardiogramma transtoracico ottenuto entro i precedenti 3 mesi;
    - Terapia medica con ACEi/ARBs, betabloccanti e, ove indicato, con antagonisti recettoriali dell’aldosterone e con sacubitril/valsartan (nei pazienti non in terapia con ACEi/ARBs), stabile da almeno un mese;
    - Valori circolanti di NT-proBNP ≥600 ng/L;
    - Età ≥ 18 anni;
    - Filtrato glomerulare stimato (formula MDRD) ≥ 60 ml/min/1,73 m2;
    - Capacità di fornire il consenso allo studio.
    E.4Principal exclusion criteria
    - Patients with acute coronary syndromes, coronary revascularization, valvular surgery or resynchronization therapy in the previous 3 months;
    - Patients with type 1 diabetes mellitus (with undetectable C-peptide serum levels) or diabetes secondary to pancreasectomy, history of diabetic ketoacidosis, at least one episode of severe hypoglycemia in the previous 6 months;
    - Patients treated with pioglitazone or saxagliptin;
    - Severe obesity (BMI >40kg/m2);
    - Clinical history of recurrent or severe genitourinary infections;
    - Active malignancies;
    - Patients with estimated life expectancy <1 year;
    - Patients with significant hepatic function abnormalities (defined as ALT/AST elevation of more than 3-fold the upper limit of reference values or elevation of total bilirubin more than 1,5-fold the upper limit of reference values, without diagnosis of Gilbert’s Syndrome);
    - Uncontrolled thyroid disease;
    - Known or suspected allergy to the drugs subjected to investigation or to one or more of the excipients;
    - Pregnant, breast-feeding women or fertile women who do not follow an adequate contraception (all women must consent to abstinence from heterosexual-intercourse, or adopt any two of the following contraceptive measures considered efficacious as: bilateral
    tube ligation, male sterilization, use of hormonal contraceptives that inhibit ovulation, copper intrauterine devices; every barrier device must be used together with a spermicide cream);
    - Inability to sign the informed consent form.
    - pazienti con sindrome coronarica acuta, rivascolarizzazione coronarica, chirurgia valvolare o
    terapia di resincronizzazione nei 3 mesi precedenti l’arruolamento;
    - pazienti con diabete di tipo 1 (C-peptide negativo) o diabete secondario a pancreatite o pancreasectomia, storia di chetoacidosi diabetica, episodio di ipoglicemia severa che necessiti l’intervento di altre persone nei sei mesi precedenti l’arruolamento;
    - pazienti in trattamento con pioglitazone o saxagliptin, per i quali sono emerse evidenze di una associazione con un rischio incrementato di ospedalizzazione per scompenso cardiaco;
    - obesità grave (BMI >40kg/m2);
    - storia di infezioni genitourinarie ricorrenti o gravi;
    - malattia neoplastica attiva;
    - pazienti con aspettativa di vita stimata <1 anno;
    - pazienti con alterazione significativa della funzione epatica (definita come incremento delle AST/ALT >3 volte il limite superiore di normalità o di bilirubinemia totale > 1,5 volte il limite superiore di normalità in assenza di sindrome di Gilbert);
    - tireopatia non adeguatamente controllata;
    - allergia nota o sospetta al farmaco in studio o ad uno degli eccipienti;
    - donne in gravidanza o in allattamento al seno, donne fertili eterosessualmente attive in assenza di metodi contraccettivi efficaci;
    - rifiuto o incapacità di dare il consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    1-year variation in NT-proBNP plasma concentrations
    Variazione a un anno dei livelli circolanti di NT-proBNP
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 YEAR
    1 ANNO
    E.5.2Secondary end point(s)
    1-year variations in exercise capacity, measured as peak oxygen consumption at cardiopulmonary test
    Variazione a un anno della capacità funzionale del paziente, misurata con il consumo di ossigeno al picco del test cardiopolmonare
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 YEAR
    1 ANNO
    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 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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    i pazienti saranno randomizzati ad una delle due seguenti strategie farmacologiche di ottimizza
    Patients will be randomly allocated to one of the two following therapeutic strategies, both aimed
    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 EEA0
    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 months6
    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 months6
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 66
    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)
    the study does not have any plans for treatment after its conclusion
    non sono previsti programmi di trattamento una volta conclusa la sperimentazione
    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 Decision2018-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-13
    P. End of Trial
    P.End of Trial StatusOngoing
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