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    Summary
    EudraCT Number:2011-001408-37
    Sponsor's Protocol Code Number:CARDIODIAB
    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:2012-04-10
    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 number2011-001408-37
    A.3Full title of the trial
    Effects of Liraglutide on left ventricular (LV) morphology, function and energy metabolism in patients with type 2 diabetes and heart failure : an in vivo cardiac Magnetic Resonance Imaging and 31P Spectroscopy study.
    Effetti della Liraglutide sul metabolismo energetico, morfologia e funzione del ventricolo sinistro (VS) nei pazienti con diabete di tipo 2 e insufficienza cardiaca: uno studio in vivo con Risonanza Magnetica cardiaca e spettroscopia del 31P.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Liraglutide on metabolism and function of the left ventricle in patients with type 2 diabetes and heart problems: study with RMN investigations
    Effetto della Liraglutide sul metabolismo e sulla funzionalita' del ventricolo sinistro nei pazienti con diabete di tipo 2 e problemi cardiaci : studio di risonanza magnetica.
    A.4.1Sponsor's protocol code numberCARDIODIAB
    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 CENTRO S. RAFFAELE DEL MONTE TABOR
    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 supportNOVO NORDISK
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione San Raffaele del Monte Tabor
    B.5.2Functional name of contact pointMedicina generale - indirizzo diab.
    B.5.3 Address:
    B.5.3.1Street Addressvia Olgettina,60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number02.26432614
    B.5.5Fax number02.26432771
    B.5.6E-mailperseghin.gianluca@hsr.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 VICTOZA*SC 2PEN 3ML 6MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderNOVO NORDISK 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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIRAGLUTIDE
    D.3.9.1CAS number 204656-20-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Yes
    D.3.11.13.1Other medicinal product typenatura chimica
    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.2.1.2Country 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 INNGLIMEPIRIDE
    D.3.9.1CAS number 93479971
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Yes
    D.3.11.13.1Other medicinal product typenatura chimica
    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
    patients affected by type 2 diabetes and heart failure
    pazienti maschi affetti da diabete di tipo 2 e scompenso cardiaco
    E.1.1.1Medical condition in easily understood language
    type 2 diabetes and heart failure
    diabete di tipo 2 e scompenso cardiaco
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10012654
    E.1.2Term Diabetic complications cardiovascular
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    verify the hypothesis whether the administration of Liraglutide is able not only to improve glycemic control but also energy metabolism and function of the left ventricle (LV) in patients with type 2 diabetes
    verificare l'ipotesi se la somministrazione di Liraglutide è in grado di migliorare non solo il compenso glicemico ma anche il metabolismo energetico e la funzione del ventricolo sinistro (VS) nei pazienti con diabete di tipo 2
    E.2.2Secondary objectives of the trial
    to identify the pathogenic mechanisms responsible for the potential improvement of left ventricular function during treatment with liraglutide in patients with type 2 diabetes.
    identificare i meccanismi patogenetici responsabili del potenziale miglioramento della funzione ventricolare sinistra durante il trattamento con Liraglutide nei pazienti con diabete di tipo 2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age between 40-70 years - men with type 2 diabetes for at least 1 year - HbA1c> 7% but less than 10% for at least the last 6 months during treatment with metformin 2 g / day - Ejection Fraction <50% but not more than 25%
    - Età compresa tra 40-70 anni - uomini affetti da diabete di tipo 2 da almeno 1 anno - HbA1c &gt; 7% ma inferiore al 10% per almeno gli ultimi 6 mesi durante il trattamento con metformina a 2 g/die - Frazione di eiezione &lt; 50% ma superiore al 25%
    E.4Principal exclusion criteria
    - Body mass index> 32 kg/m2 - autonomic neuropathy - Creatinine> 1.5 mg / dl - Any disease / condition that might interfere with the study - Unstable Angina - Arrhythmia - Patients on metabolic treatment (trimetazidine, acipimox, perhexeline, thyroid hormones) - Patients unable to attend the study or to undergo testing protocol (contraindications to MRI such as pacemakers, metal objects and non-removable) - Claustrophobia - Anterior myocardial infarction
    - Indice di massa corporea &gt;a 32 kg/m2 - Neuropatia autonomica - Creatinina &gt; 1,5 mg/dl - Qualsiasi malattia/condizione che possa interferire con lo studio - Angina instabile - Aritmie - I pazienti in terapia metabolica (trimetazidina, acipimox, perhexeline, ormoni tiroidei) - Pazienti con impossibilità di frequentare lo studio o di sottoporsi a test di protocollo (controindicazioni alla RM come pacemaker e oggetti metallici non rimovibili) - Claustrofobia - infarto miocardico anteriore
    E.5 End points
    E.5.1Primary end point(s)
    20% increase in the ratio PCr / ATP ratio than in Liraglutide Glimepiride study obtained by magnetic resonance spectroscopy 31P.
    incremento 20% del rapporto PCr/ATP ratio in Liraglutide rispetto a Glimepiride ottenuta mediante studio di risonanza magnetica in spettroscopia del 31P.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 months, 4 months
    1 mese, 4 mesi
    E.5.2Secondary end point(s)
    10% increase in ejection fraction compared with Liraglutide Glimepiride obtained by cine cardiac magnetic resonance imaging study.
    incremento del 10% della frazione di eiezione in Liraglutide rispetto a Glimepiride ottenuta mediante studio di cine risonanza magnetica cardiaca.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 months, 4 months
    1 mese, 4 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 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.8.6 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 years0
    E.8.9.1In the Member State concerned months24
    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.1.1Number of subjects for this age range: 0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female No
    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 state30
    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)
    depending on the observed response to treatment - both on target glycemic control than on that on target of ejection fraction - the patient will continue the intervention began during treatment or change (if not satisfactory).
    a seconda della risposta osservata ai trattamenti – sia sul target compenso glicemico che su quello di frazione di eiezione – il paziente proseguirà l’intervento iniziato durante il trattamento o lo modificherà (se non soddisfacente).
    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 Decision2011-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-12
    P. End of Trial
    P.End of Trial StatusOngoing
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