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    Summary
    EudraCT Number:2012-005778-74
    Sponsor's Protocol Code Number:NN9211-4083
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-06
    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 number2012-005778-74
    A.3Full title of the trial
    The efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes. A 26 week randomised, insulin capped, placebo-controlled, double-blind, parallel group, multinational, multi-centre trial
    Efficacia e sicurezza di liraglutide in aggiunta al trattamento con insulina nel diabete di tipo 1. Studio della
    durata di 26 settimane, randomizzato, con dose limite di insulina , controllato con placebo, in doppio cieco, a gruppi paralleli, multinazionale, multicentrico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes
    Efficacia e sicurezza di liraglutide in aggiunta al trattamento con insulina nel diabete di tipo 1.
    A.3.2Name or abbreviated title of the trial where available
    ADJUNCT TWO™
    A.4.1Sponsor's protocol code numberNN9211-4083
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1138-0619
    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 SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointGlobal Clinical Registry (GCR,1452)
    B.5.3 Address:
    B.5.3.1Street AddressVandtårnsvej 114, VTB
    B.5.3.2Town/ citySøborg
    B.5.3.3Post code2860
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.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
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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.3.9.4EV 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 number6.0
    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 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 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
    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
    Diabetes Mellitus, Type 1
    Diabete Mellito di tipo 1
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes
    Diabete di tipo 1
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10045228
    E.1.2Term Type I diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm superiority of liraglutide compared to placebo, both adjunct to insulin treatment, on glycaemic control, after 26 weeks of treatment in subjects with established type 1 diabetes in inadequate glycaemic control.
    Confermare la superiorità di liraglutide in confronto con
    placebo nel controllo glicemico, in entrambi in aggiunta al trattamento con insulina,
    dopo 26 settimane di trattamento in soggetti con diagnosi di diabete di tipo 1 in
    controllo glicemico inadeguato.
    E.2.2Secondary objectives of the trial
    1. To confirm superiority of liraglutide compared to placebo, both adjunct to insulin treatment, with regards to body weight loss after 26 weeks of treatment in subjects with established type 1 diabetes in inadequate glycaemic control.
    2. To evaluate safety and tolerability of liraglutide compared to placebo, both adjunct to insulin treatment, during 26 weeks of treatment in subjects with type 1 diabetes in inadequate glycaemic control.
    1. Confermare la superiorità di liraglutide in confronto con
    placebo, entrambi in aggiunta al trattamento con insulina, sulla perdita di peso
    corporeo dopo 26 settimane di trattamento in soggetti con diagnosi di diabete di tipo 1
    con un inadeguato controllo glicemico.
    2. Valutare la sicurezza e la tollerabilità di liraglutide in
    confronto con placebo, entrambi in aggiunta al trattamento con insulina, durante 26
    settimane di trattamento in soggetti con diabete di tipo 1 con un inadeguato controllo
    glicemico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
    2. Male or female, aged ≥ 18 years at the time of signing informed consent
    3. Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to Visit 1 (i.e. screening)
    4. Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment ≥ 6 months prior to Visit 1 (i.e. screening)
    5. Stable insulin treatment ≥ 3 months prior to Visit 1 (i.e. screening), as judged and documented by the investigator
    6. HbA1c 7.0–10.0 % (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53–86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
    1. Consenso informato ottenuto prima di qualsiasi attività correlata allo studio. Per
    attività correlate allo studio s’intende qualsiasi procedura svolta all’interno dello
    studio, incluse le attività richieste per stabilire l’idoneità a partecipare dei
    pazienti.
    2. Uomini o donne con età ≥ a 18 anni al momento della firma del consenso
    informato.
    3. Diabete mellito di tipo 1 (diagnosticato clinicamente) da ≥ 12 mesi prima della
    visita 1 (visita di screening).
    4. Trattamento basal-bolus o con CSII (continuous subcutaneous insulin infusion)
    da ≥ 6 mesi dalla visita 1.
    5. Trattamento stabile con insulina ≥ 3 mesi prima della visita 1 (visita di
    screening), valutato e documentato dallo sperimentatore.
    6. Valori di HbA1c fra 7.0-10.0 %, estremi inclusi (Controllo del Diabete e studio
    delle complicanze (DCCT)), analizzati dal laboratorio centrale (visita 1,
    screening) e corrispondenti a 53-86 mmol/mol (Federazione Internazionale della
    Clinica Chimica (IFCC))
    E.4Principal exclusion criteria
    1. Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors
    2. Use of any medication, which in the investigator’s opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject’s safety. Premix insulin is not allowed
    3. Known proliferative retinopathy or maculopathy requiring acute treatment
    4. Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
    5. Uncontrolled/ untreated blood pressure at screening (Visit 1) (after resting for 5 min) while sitting > 160 mmHg for systolic or >100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
    6. History of acute or chronic pancreatitis
    7. Screening (Visit 1) calcitonin value ≥ 50 ng/L
    8. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN2)
    9. Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
    1. Precedente uso di agonisti del recettore del GLP-1 o di inibitori del DDP- IV
    2. Uso di qualsiasi farmaco che secondo lo sperimentatore può interferire con il
    controllo glicemico (es. corticosteroidi sistemici) o con influire sulla sicurezza del
    soggetto. Non è permessa l’insulina premiscelata.
    3. Accertata retinopatia proliferativa o maculopatia che necessiti trattamento
    acuto.
    4. Neuropatia severa, in particolare neuropatia autonoma, es. gastroparesi, a
    giudizio dello sperimentatore.
    5. Pressione sanguigna incontrollata/non trattata allo screening (visita 1)(dopo una
    attesa di 5 minuti) > di 160 mmHg per la sistolica e > di 100 mmHg per la distolica
    durante la seduta (è permesso ripetere la misurazione a visita 2 (prima di effettuare le
    attività connesse allo studio) per escludere ipertensione da camice-bianco
    6. Storia di pancreatite cronica o acuta.
    7. Valore di Calcitonina allo screening (visita 1) ≥ 50 ng/L.
    8. Storia familiare o personale di carcinoma midollare della tiroide o neoplasia
    endocrina multipla di tipo 2 (MEN 2).
    9. Diagnosi di neoplasie maligne entro gli ultimi 5 anni(ad eccezione del carcinoma
    delle cellule basali o squamose della pelle).
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in glycosylated haemoglobin (HbA1c)
    Variazione del valore iniziale dell’emoglobina glicata (HbA1c)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 26 weeks of treatment
    Dopo 26 settimane di trattamento.
    E.5.2Secondary end point(s)
    1. Change from baseline in body weight
    2. Number of treatment-emergent symptomatic hypoglycaemic episodes
    1. Variazione dal valore di partenza del peso corporeo
    2. Numero di episodi ipoglicemici sintomatici in seguito al trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. After 26 weeks of treatment
    2. During 26 weeks of treatment
    1. Dopo 26 settimane di trattamento
    2. Durante le 26 settimane di trattamento
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 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 trial6
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA92
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    European Union
    South Africa
    United States
    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
    Ultima visita ultimo soggetto
    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 months11
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days14
    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: 744
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 804
    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)
    N/A
    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 Decision2014-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
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