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    Summary
    EudraCT Number:2011-002468-26
    Sponsor's Protocol Code Number:DKprotokol(LIVE)v5
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-12
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-002468-26
    A.3Full title of the trial
    Liraglutide in chronic heart failure. A randomised, double-blind, placebo-controlled study of the effect of LIraglutide on left VEntricular function in chronic heart failure patients with and without type 2 diabetes (The LIVE-study).
    Liraglutid’s effekt ved hjertesvigt. Et randomiseret, dobbelt-blindet, placebo-kontrolleret studie af effekten af LIraglutid på venstre VEntrikelfunktion hos kronisk hjertesvigt patienter med og uden type 2 diabetes (LIVE-studiet).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Liraglutide in chronic heart failure. A randomised, double-blind, placebo-controlled study of the effect of LIraglutide on the left VEntricular function in patients with chronic heart failure with and without type 2 diabetes (The LIVE-study).
    Liraglutid’s effekt ved hjertesvigt. Et randomiseret, dobbelt-blindet, placebo-kontrolleret studie der vuderer effekten af LIraglutid på venstre VEntrikelfunktion hos kronisk hjertesvigt patienter med og uden type 2 diabetes (LIVE-studiet).
    A.3.2Name or abbreviated title of the trial where available
    LIVE
    LIVE
    A.4.1Sponsor's protocol code numberDKprotokol(LIVE)v5
    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 SponsorAllan Flyvbjerg
    B.1.3.4CountryDenmark
    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.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNordsjællands Hospital
    B.5.2Functional name of contact pointLise Tarnow
    B.5.3 Address:
    B.5.3.1Street AddressDyrehavevej 29
    B.5.3.2Town/ cityHillerød
    B.5.3.3Post code3400
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4540895257
    B.5.6E-maillise@vibeholm.com
    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 6 mg/ml injektionsvæske
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameLiraglutide
    D.3.2Product code EU/1/09/529/002
    D.3.4Pharmaceutical form Suspension for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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 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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary objective: To investigate the effect of Liraglutide 1.8 mg once daily compared to placebo on left ventricular eject fraction in Chromic heart failure patients with and without Type 2 diabetes after 24 weeks of treatment.

    Secondary objectives: To investigate the effect of Liraglutide 1.8 mg once daily compared to placebo on left ventricular diastolic function, on plasma levels of NT-proBNP, on symptoms of heart failure and quality of life over 24 weeks of treatment.
    E.1.1.1Medical condition in easily understood language
    To investigate the effect of Liraglutide in Chromic heart failure patients with and without Type 2 diabetes after 24 weeks of treatment.

    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    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
    To investigate the effect of Liraglutide 1.8 mg once daily compared to placebo for 24 weeks on left ventricular systolic function in CHF patients with and without T2D.
    At undersøge effekten af Liraglutid 1,8 mg én gang dagligt sammenlignet med placebo i 24 uger på venstre ventrikel systoliske funktion (LVEF) hos CHF patienter med og uden T2D.
    E.2.2Secondary objectives of the trial
    To investigate the effect of Liraglutide compared to placebo on:
    • Left ventricular diastolic function
    • Functional capacity measured by a six minute walk test (6MWT)
    • Plasma NT-proBNP levels
    • Blood pressure
    • Quality of life - estimated by a standardised questionnaire (Minnesota Living with Heart Failure questionnaire (MLHF))
    At undersøge effekten af Liraglutid sammenlignet med placebo på:
    • Venstre ventrikels diastoliske funktion
    • Venstre ventrikel systolisk funktion målt ved TDI:1) Summerede systoliske peak hastigheder i AV blok, 2) s’ og a’ relation 3) Global strain, 4) ESV, og 5) EDV
    • Funktionel kapacitet, målt ved en 6 minutters gangtest
    • Plasma NT-proBNP niveauer
    • Blodtryk
    • Livskvalitet vurderet ved et standardiseret spørgeskema (Minnesota Living with Heart Failure questionnaire (MLHF))
    • Indlæggelse og død pga. hjertesvigt
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • CHF (NYHA-class I, II or III) at visit 0
    • LVEF ≤ 45 % (measured within 30 days prior to visit 1)
    • Age 30 to 85 (both inclusive)
    • Optimal medical treatment in 3 months and stable treatment with ACE-inhibitors, AT2-antagonists, beta-blockers and/or aldosterone antagonists for the last 30 days prior to randomisation (visit 1)
    • Able to understand the written patient information and to give informed consent

    For patients with diabetes exclusively
    • T2D (WHO criteria), diagnosed at least 3 months prior to visit 0
    • Patients with diabetes must be either untreated or treated with one or more oral anti-diabetic drugs or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs
    • Stable dose of anti diabetic treatment for 30 days prior to randomisation (visit 1)
    • CHF (NYHA-klasse I, II eller III) ved besøg 0
    • LVEF ≤ 45 % (inden for 30 dage før besøg 1)
    • Alder 30 til 85 (begge inklusive).
    • Stabil og optimal behandling med ACE-hæmmere, AT2-antagonister, β-blokkere og/eller aldosteron antagonister samt evt. indsættelse af bi-ventrikulær pacemaker minimum 3 måneder forud for randomisering (besøg 1)
    • Kunne forstå den skriftlige patientinformation og kunne give informeret samtykke.

    For patienter med diabetes
    • T2D (WHO kriterier), diagnosticeret mindst 3 måneder forud for besøg 0
    • Patienter med diabetes skal enten være ubehandlet eller behandlet med en eller flere orale antidiabetiske lægemidler eller behandlet med humant NPH-insulin eller langtidsvirkende insulinanalog, alene eller i kombination med orale medicin
    • Stabil dosis af antidiabetisk behandling i 30 dage forud for randomisering (besøg 1)
    E.4Principal exclusion criteria
    •Cardiac
    • Myocardial infarction (MI) within the last three months prior to visit 0
    • Coronary revascularization within the last three months prior to visit 0
    • Hospitalisation due to incompensated heart disease within 30 days prior to randomisation (visit 1)
    • CHF (NYHA class IV)
    • ECG suggestive of malign ventricular arrhythmia at visit 0
    • Prolonged QT-interval (>500 ms) at visit 0
    • Uncorrected valvular heart disease at visit 0
    • Current myocardial or pericardial infection
    • Obstructive hypertrophic cardiomyopathy
    • Current planned coronary revascularisation
    • Poor image quality on echocardiography

    Diabetes
    • Type 1 diabetes
    • HbA1c >10% measured at visit 0
    • Diabetic gastroparesis
    • Use of GLP-1 receptor agonists (Exenatide, Liraglutide or other) or glitazones, pramlintide or any DPP-IV inhibitor within 30 days prior to randomisation (visit 1)
    • Use of insulin other than human NPH-insulin or long-acting insulin analogue within 30 days prior to randomisation (visit 1)

    Other/general
    • Known or suspected hypersensitivity to trial product or related products
    • Alcohol/drug abuse
    • Pregnant or nursing women
    • Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
    • Cancer unless in complete remission for ≥5 years
    • Liver disease with elevated plasma alanine aminotransferase (ALT) of more than three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
    • Inflammatory bowel disease
    • Acute or chronic pancreatitis
    • Compromised kidney function (eGFR < 30 ml/min), dialysis or kidney transplantation
    • History of thyroidea adenoma or carcinoma
    • Severely elevated blood pressure (systolic >180 mmHg and/or diastolic >105 mmHg)
    • Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
    • Simultaneous participation in any other clinical intervention trial
    • Receipt of an investigational drug with 30 days prior to visit 0
    Kardiologisk
    • Myokardieinfarkt (MI) indenfor de sidste 3 måneder forud for besøg 0
    • Koronar revaskularisering inden for de sidste 3 måneder forud for besøg 0
    • Indlæggelse på grund af inkompenseret hjertesygdom inden for 30 dage før randomisering (besøg 1)
    • NYHA klasse IV
    • EKG tydende på malign ventrikulær arytmi ved besøg 0
    • Forlænget QT-interval (>500 ms) ved besøg 0
    • Ukorrigeret klapfejl ved besøg 0
    • Aktuel myokardie eller perikardie infektion
    • Obstruktiv hypertrofisk kardiomyopati
    • Aktuel planlagt koronar revaskularisering
    • Dårlig billedkvalitet på ekkokardiografi
    • Atrieflimren med påskyndet ventrikelfrekvens (i hvile > 100/min)

    Diabetes
    • Type 1 diabetes
    • HbA1c >10% målt ved besøg 0
    • Diabetisk gastroparese
    • Brug af GLP-1 receptor agonister (Exenatid, Liraglutid eller andre) eller glitazoner, pramlintid eller DPP-IV hæmmere inden for 30 dage forud for randomisering (besøg 1)
    • Brug af insulin andet end humant NPH-insulin eller langtidsvirkende insulinanalog inden for 30 dage forud for randomisering (besøg 1)

    Andre
    • Kendt eller mistænkt overfølsomhed over for Liraglutid
    • Alkohol/stofmisbrug
    • Gravide og ammende kvinder
    • Fertile kvinder der ikke bruger kemiske (P-piller, depotinjektion af progesteron, subdermal gestagen implantation, hormonel vaginalring eller transdermal depotplaster) eller mekaniske (spiraler) svangerskabsforebyggende midler
    • Kræft med mindre der er komplet remission i ≥ 5 år
    • Leversygdom med plasma alanin aminotransferase (ALAT) til over tre gange den øvre normalværdi (målt ved besøg 0 med mulighed for en gentagelse af analysen inden for en uge, den sidste målte værdi er afgørende)
    • Inflammatorisk tarmsygdom
    • Akut eller kronisk betændelse i bugspytkirtlen (pankreatit)
    • Nedsat nyrefunktion (eGFR <30 ml / min), dialyse eller nyretransplantation
    • Anamnese med thyroidea adenom eller karcinom
    • Svært forhøjet blodtryk (systolisk >180 mmHg og/eller diastolisk >105 mmHg)
    • Anden samtidig sygdom eller behandling, der i henhold til investigators vurdering gør patienten uegnet til deltagelse i studiet
    • Samtidig deltagelse i et andet klinisk interventionsstudie
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint
    Change in LVEF measured by 3D echocardiography at visit 1 and at the end of treatment after 24 weeks of intervention.

    Primære endepunkter
    Ændringen i LVEF målt ved 3D ekkokardiografi fra randomisering besøg 1 og til afslutningen af 24 ugers intervention.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of treatment after 24 weeks of intervention
    Til afslurningsbesøget, efter den 24 ugers perioden med behandling
    E.5.2Secondary end point(s)
    Secondary endpoints
    Changes from randomisation (visit 1) to end of treatment after 24 weeks of intervention in:
    • Diastolic function
    • Systolic function measured by TDI: 1) summed systolic peak velocities (s’) in the AV-plane, 2) global strain, 3) ESV, and 4) EDV
    • Functional capacity, measured by 6MWT
    • Plasma NT-proBNP levels
    • Blood pressure
    • Quality of life - evaluated by MLHF questionnaire
    • Hospitalisation
    • Mortality
    Sekundære endepunkter
    Ændringen i følgende parametre fra randomisering (besøg 1) og til afslutningen af behandlingen efter 24 ugers intervention:
    • Venstre ventrikels diastoliske funktion
    • Venstre ventrikel systolisk funktion målt ved TDI:1) Summerede systoliske peak hastigheder i AV blok, 2) s’ og a’ relation 3) Global strain, 4) ESV, og 5) EDV
    • Funktionel kapacitet, målt ved en 6 minutters gangtest
    • Plasma NT-proBNP niveauer
    • Blodtryk
    • Livskvalitet vurderet ved et standardiseret spørgeskema (Minnesota Living with Heart Failure questionnaire (MLHF))
    • Indlæggelse og død pga. hjertesvigt
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of treatment after 24 weeks of intervention
    Ved besøget efter den 24 ugers perioden med behandling
    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 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 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 concerned5
    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 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
    • Pregnancy or desire hereof
    • Safety considerations as assessed by the investigator
    • Withdrawal of informed consent
    • Graviditet eller ønske herom
    • Sikkerhedshensyn vurderet af investigator
    • Tilbagetrækning af informeret samtykke
    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 months5
    E.8.9.1In the Member State concerned days
    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) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state240
    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)
    Post trial treatment according to national and local guidelines in the hospitals
    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 Decision2011-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-01
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