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    Summary
    EudraCT Number:2018-001057-26
    Sponsor's Protocol Code Number:IRFM-7468
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-05
    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 number2018-001057-26
    A.3Full title of the trial
    Management of the patient with heart failure and diabetes: may insulin be a problem? A pilot randomized clinical study (Insulin-HF).
    Trattamento del paziente con insufficienza cardiaca e diabete: l¿insulina pu¿ essere un problema? Studio pilota multicentrico randomizzato, (Insulin-HF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Management of the patient with heart failure and diabetes: may insulin be a problem?
    Trattamento del paziente con insufficienza cardiaca e diabete: l¿insulina pu¿ essere un problema?
    A.3.2Name or abbreviated title of the trial where available
    Insulin-HF
    Insulin-HF
    A.4.1Sponsor's protocol code numberIRFM-7468
    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 SponsorIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    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 Fam.Casiraghi -Premio Ric. Cardiov 2017
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    B.5.2Functional name of contact pointDIPARTIMENTO DI RICERCA CARDIOVASCO
    B.5.3 Address:
    B.5.3.1Street AddressVIA LA MASA, 19
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number02-39014508
    B.5.5Fax number02-33200049
    B.5.6E-maillidia.staszewsky@marionegri.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 HUMALOG - 100 U/ML SOLUZ. INIETTABILE 5 CARTUCCE 3 ML IM IV
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NEDERLAND BV
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.9Recombinant medicinal product Yes
    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 diabetes
    Insufficienza cardiaca e diabete
    E.1.1.1Medical condition in easily understood language
    Heart failure and diabetes
    Insufficienza cardiaca e diabete
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10007555
    E.1.2Term Cardiac failure (NOS)
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main endpoint of this pilot study is to assess comparatively in patients with heart failure and T2DM the benefit/risk profile over 1-year follow-up of two antidiabetic strategies, standard care with vs without insulin.
    L¿obiettivo primario dello studio ¿ confrontare in pazienti con insufficienza cardiaca e T2DM il rischio/beneficio di due strategie terapeutiche, standard per le cure del T2DM + insulina vs. standard per le cure del T2DM + non-insulina
    E.2.2Secondary objectives of the trial
    The effects of the two antidiabetic strategies will be also evaluated in terms of the following safety and efficacy markers:
    ¿ incidence of documented hypoglycemic episodes;
    ¿ body weight;
    ¿ natriuretic peptide;
    ¿ urinary albumin excretion;
    ¿ NYHA class
    ¿ hospitalizations for HF and for any cause;
    ¿ CV and non-CV mortality;
    ¿ episodes of ketoacidosis/lactic acidosis;
    ¿ LVEF and E/e¿ by echocardiography;
    ¿ HbA1c.
    Le due strategie in studio saranno confrontate anche mediante i seguenti indicatori di sicurezza ed efficacia:
    ¿ Incidenza di episodi documentati di ipoglicemia,
    ¿ Peso corporeo,
    ¿ Peptide natriuretici,
    ¿ Escrezione dell¿albumina urinaria,
    ¿ Classe NYHA,
    ¿ Ospedalizzazione per cause CV e per cause non-CV,
    ¿ Mortalit¿ CV e non-CV,
    ¿ Episodi di acidosi lattica/chetoacidosi
    ¿ Frazione di eiezione del ventricolo sinistro ed E/e¿ valutate con ecocardiografia,
    ¿ HbA1c.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women aged =70 years;
    2. at discharge after admission to hospital for worsening of HF or ambulatory patients with chronic HF;
    3. New York Heart Association (NYHA) class II or III;
    4. with any level of left ventricular ejection fraction;
    5. plasma natriuretic peptide (BNP) =200 pg/mL or N-terminal pro-BNP =900 pg/mL (NT pro-BNP)
    6. prior history or newly diagnosed T2DM
    7. candidate by the responsible physician to insulin therapy;
    8. signed informed consent.
    • pazienti di ambo i sessi =70 anni;
    • alla dimissione di un ricovero per peggioramento dell’IC o pazienti ambulatoriali con diagnosi di IC cronica;
    • classe funzionale NYHA II-III;
    • con qualsiasi livello di frazione di eiezione del ventricolo sinistro;
    • con concentrazione di peptide natriuretico di tipo B (BNP) =200 pg/ml oppure di NT-proBNP=900 pg/ml;
    • con pregressa o nuova diagnosi di T2DM;
    • candidati secondo criteri del medico responsabile a una terapia con insulina;
    • consenso informato firmato dal paziente.
    E.4Principal exclusion criteria
    1. significant renal insufficiency (GFR <30 mL/min/1.73 m2) or severe liver disease (liver function test abnormalities (alanine or aspartate aminotransferase = 3 × upper limit of normal [ULN]);
    2. levels of hemoglobin <10 g/dl;
    3. HbA1c =5% or =11%;
    4. unstable diabetes: type of diabetes presentation in patients with an anamnesis of frequent episodes of hypoglycemia, hyperglycemic hyperosmolar status, ketoacidosis or lacto acidosis;
    5. planned CV surgery or angioplasty in 3 months;
    6. any non-cardiac disease that shortens life expectancy to<1 year (e.g. most cancers);
    7. inability to comply with study protocol;
    8. participation to another interventional clinical study.
    • insufficienza renale significativa (GFR <30 mL/min/1.73 m2) o epatopatia grave (ALT o AST=3 x limite superiore di normalità (ULN);
    • concentrazione di emoglobina<10 g/dL;
    • livello di HbA1c=5% o =11%;
    • diabete instabile: paziente con frequenti episodi di ipoglicemia, di iperglicemia e condizioni di iperosmolarità o acidosi lattica/chetoacidosi;
    • intervento pianificato di chirurgia o angioplastica nei 3 mesi successivi alla randomizzazione;
    • malattia cardiaca e non cardiaca, che possa ridurre l’aspettativa di vita a <1 anno (i.e. principalmente le malattie tumorali);
    • impossibilità di seguire adeguatamente il protocollo dello studio;
    • partecipazione a un altro studio d’intervento.
    E.5 End points
    E.5.1Primary end point(s)
    The main endpoint of this pilot study is to assess in patients with heart failure and T2DM whether an anti-diabetic strategy of standard care without insulin decreases glucose variability compared to a strategy of standard care which includes insulin.
    L’endpoint primario di questo studio pilota è di valutare in pazienti con IC e T2DM, quanto una strategia di terapia antidiabetica standard senza insulina diminuisce la variabilità glicemica (espressione dell’instabilità metabolica) in confronto a una strategia terapeutica standard con insulina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    incidence of documented hypoglycemic episodes;; body weight; natriuretic peptide; urinary albumin excretion; NYHA class; hospitalizations for HF and for any cause; CV and non-CV mortality; episodes of ketoacidosis/lactic acidosis;; LVEF and E/e¿ by echocardiography;; HbA1c.
    incidenza di episodi documentati di ipoglicemia,; Peso corporeo; Peptide natriuretici; escrezione dell¿albumina urinaria; classe NYHA; ospedalizzazione per cause CV e per cause non-CV; Mortalit¿ CV e non-CV; episodi di acidosi lattica/chetoacidosi; frazione di eiezione del ventricolo sinistro ed E/e¿ valutate con ecocardiografia;; HbA1c.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months; 12 months; 12 months; 12 months; 12 months; 12 months; 12 months; 12 months; 12 months; 12 months
    12 mesi; 12 mesi; 12 mesi; 12 mesi; 12 mesi; 12 mesi; 12 mesi; 12 mesi; 12 mesi; 12 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 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    STANDARD PER LE CURE DEL T2DM NON-INSULINA
    STANDARDS OF CARE IN T2DM NON-INSULIN
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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 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
    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.1.1.1In 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 142
    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 No
    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 state142
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 142
    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)
    NA
    NA
    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 Decision2018-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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