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    The EU Clinical Trials Register currently displays   35540   clinical trials with a EudraCT protocol, of which   5840   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-005317-39
    Sponsor's Protocol Code Number:NewLira
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-01-17
    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 number2012-005317-39
    A.3Full title of the trial
    Liraglutide in type 1 diabetes - A randomised, double-blind, placebo-controlled, parallel group, multi-centre trial of 242 liraglutide treatment in subjects with newly-diagnosed type 1 diabetes (The NewLira Study)
    Liraglutid til type 1 diabetikere - Et randomiseret, dobbelt-blindet, placebo-kontrolleret, multi-center studie af effekten af liraglutid som
    supplement til insulinbehandling på beta-celle funktion hos ny opdagede patienter med type 1 diabetes (NewLira studiet).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Liraglutide in type 1 diabetes - A randomised, double-blind, placebo-controlled, parallel group, multi-centre trial of 242 liraglutide treatment in subjects with newly-diagnosed type 1 diabetes (The NewLira Study)
    Liraglutid til type 1 diabetikere - Et randomiseret, dobbelt-blindet, placebo-kontrolleret, multi-center studie af effekten af liraglutid som
    supplement til insulinbehandling på beta-celle funktion hos ny opdagede patienter med type 1 diabetes (NewLira studiet).
    A.3.2Name or abbreviated title of the trial where available
    NewLira
    NewLira
    A.4.1Sponsor's protocol code numberNewLira
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1137-3221
    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 SponsorDepartment of Endocrinology, Hvidovre Hospital
    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 A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCoordinating Investigator
    B.5.2Functional name of contact pointThomas Dejgaard
    B.5.3 Address:
    B.5.3.1Street AddressKettegård Allé 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post code2650
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4526796103
    B.5.6E-mailtfdejgaard@dadlnet.dk
    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 A/S
    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.3.4Pharmaceutical form Suspension for injection in pre-filled pen
    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.3.9.2Current sponsor codeno
    D.3.9.3Other descriptive nameGLP-1 analog
    D.3.9.4EV Substance CodeSUB25238
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,6
    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 in pre-filled pen
    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
    The effect of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.
    Also to investigate the effect on postprandial glucagon levels following sustacal meal test, HbA1c, insulin dose, self-monitored blood glucose profile,frequency of hypoglycaemic events, fasting and postprandial cholesterol profile, weight, waist circumference and quality of life.
    .
    Effekten af liraglutid 1,8 mg dagligt sammenlignet med placebo i 52 uger på ændringer i betacelle funktion hos patienter med nydiagnosticeret type 1 sukkersyge som supplement til insulin behandling
    Derudover undersøger ønsker vi at undersøge effekten på postprandielt glukagon niveau efter sustacal måltidstest, Hba1c, insulin dosis, blodsukkerprofil, hyppighed af hypoglukæmi, faste-samt postprandial kolesterol profil, vægt, livvidde og livskvalitet.
    E.1.1.1Medical condition in easily understood language
    The effect of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes
    Effekten af liraglutid 1,8 mg dagligt sammenlignet med placebo i 52 uger på ændringer i betacelle funktion hos patienter med nydiagnosticeret type 1 sukkersyge
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    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 and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.
    At undersøge effekten af liraglutid 1,8 mg en gang dagligt sammenlignet med placebo i 52 uger på ændringen i betacelle funktion i patienter med ny-diagnosticeret type 1 diabetes som et supplement til insulinbehandling
    E.2.2Secondary objectives of the trial
    To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in: Postprandial glucagon levels following sustacal meal test, HbA1c, insulin dose, self-monitored blood glucose profile, fasting and postprandial cholesterol profile, weight, waist circumference and quality of life.
    Other secondary objectives are to investigate the treatment effect on length of insulin remission period and frequency of hypoglycaemic events.
    At undersøge effekten af liraglutid 1,8 mg en gang dagligt sammenlignet med placebo i 52 uger som tillæg til insulinbehandling på ændringen i: glukagon respons efter sustacal måltidstest, HbA1c, insulindoser, blodsukker profiler målt af patienten selv (SMBG), lipid profil ved faste samt stimuleret med sustacal måltidstest, vægt, livvidde og livskvalitet.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    *Type 1 diabetes according to WHO criteria diagnosed ≤ 6 weeks before visit 0
    *Age 18 - 40 years – both inclusive
    *Postprandial C-peptide > 0.2 nmol/l following sustacal meal test
    *Able to understand the written patient information and to give informed consent
    *Type 1 diabetes ifølge WHO kriterier diagnosticeret ≤ 6 uger
    *Alder 18 - 40 år
    *C-peptid > 0,2 nmol/l efter en sustacal måltidstest.
    *I stand til at forstå den skriftlige patientinformation og til at give informeret samtykke
    E.4Principal exclusion criteria
    *Type 2 diabetes
    *Body mass index <20 kg/m2 at Visit 0
    *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
    *Pregnant or nursing women
    *Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
    *Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at visit 0
    *Cancer unless in complete remission for > 5 years
    *Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors, or other GLP-1 mimetics which in the Investigator’s opinion could interfere with glucose metabolism
    *Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 3 months
    *Inflammatory bowel disease
    *Calcitonin ≥ 50 ng/l at visit 0
    *Hypoglycaemia unawareness (unability to register low blood glucose)
    *Acute or chronic pancreatitis
    *History of thyroid adenoma or carcinoma
    *Known or suspected hypersensitivity to trial product or related products
    *Abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as deemed by the investigators
    *Receipt of an investigational drug within 30 days prior to visit 0
    *Simultaneous participation in any other clinical intervention trial
    *Type 2 diabetes
    *BMI < 20 kg/m2 ved besøg 0
    *Fertile kvinder, der ikke bruger kemiske (p-piller, hormonspiral, vaginal ring eller depotpræparater med gestagen) eller mekaniske (spiral) præventionsmidler
    *Gravide eller ammende kvinder
    *Nedsat nyrefunktion med eGFR < 60 ml/min/1,73 m2, dialyse patient eller nyretransplanteret ved besøg 0
    *Leversygdom med ALAT (alanin-aminotransferase – et enzym fra leveren) forhøjelse > 3 gange den øvre normalværdi ved besøg 0
    *Tidligere kræftsygdom, medmindre patienten har været sygdomsfri i > 5
    *Behandling med binyrebarkhormon tabletter, calcineurin hæmmere, dipeptidyl peptidase 4 (DPP4) hæmmere eller anden medicin som ifølge forsøgsansvarliges vurdering kan interagere med glukose metabolismen.
    *Manglende evne til at mærke for lavt blodsukker
    *Akut eller kronisk betændelse i bugspytkirtlen
    *Inflammatorisk tarmsygdom
    *Calcitonin ≥ 50 ng/l ved besøg 0
    *Tidligere godartede eller ondartede knuder i skjoldbryskkirtlen
    *Anden samtidig sygdom eller behandling, der efter forsøgsansvarliges vurdering gør patienten uegnet til studie deltagelse
    *Alkohol eller stof misbrug
    *Overfølsomhed over for liraglutid
    *Anvendelse af testpræparat indenfor 30 dage forud for besøg 0
    *Samtidig deltagelse i andre kliniske interventionsstudier
    E.5 End points
    E.5.1Primary end point(s)
    Change in area under the C-peptide curve to a sustacal meal from randomisation to the end of treatment.
    Ændring i C-peptid koncentrationen (et mål for insulinproduktionen) stimuleret ved en sustacal måltidstest fra besøg 1 til studieafslutning efter 52 ugers behandling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of treatment after 52 weeks of intervention.
    Til afslutningsbesøg efter 52 ugers behandling.
    E.5.2Secondary end point(s)
    Change in the following parameters from randomisation to the end of treatment:

    * Maximal postprandial C-peptide concentration following sustacal meal test
    * Incremental C-peptide response following sustacal meal test
    * Beta-cell sensitivity to glucose during the sustacal meal test as estimated by use of mathematical modelling
    * Glucagon response following sustacal meal test
    * Daily insulin dose
    * HbA1c
    * Self-monitored blood glucose (SMBG) profile
    * Fasting and postprandial lipid profile following sustacal meal test
    * Weight
    * Waist circumference
    * Quality of life
    Sekundære endepunkter er ændring fra besøg 1 til studieafslutning efter 52 ugers behandling i: Maksimal C-peptid koncentration efter sustacal måltidstest, stigning i C-peptid efter sustacal måltidstest, betacelle følsomhed for glukose under sustacal måltidstest udregnet ved matematisk model, HbA1c, insulindoser, blodsukker profiler målt af patienten selv (SMBG), glukagon respons efter sustacal måltidstest, lipid profil ved faste samt stimuleret med sustacal måltidstest, vægt, livvidde og livskvalitet
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of treatment after 52 weeks of intervention.
    Til afslutningsbesøg efter 52 ugers 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) 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 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 Yes
    E.8.1.7.1Other trial design description
    muliticenter
    multi-centre
    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 concerned8
    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 the 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 months6
    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.1.1.1In 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: 80
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    Followup on glycaemic control and optimisation of treatment
    Opfølgning på glykæmisk kontrol og optimering af behandling
    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 Decision2013-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-12
    P. End of Trial
    P.End of Trial StatusOngoing
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