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    Summary
    EudraCT Number:2014-003667-37
    Sponsor's Protocol Code Number:NA
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-11-05
    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 ConcernedFinland - Fimea
    A.2EudraCT number2014-003667-37
    A.3Full title of the trial
    Incretin-based therapy in preclinical type 1 diabetes in adults.
    Inkretiini-perusteinen tyypin 1 diabeteksen esiasteen hoito aikuisilla.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Incretin-based therapy in preclinical type 1 diabetes in adults.
    Inkretiini-perusteinen tyypin 1 diabeteksen esiasteen hoito aikuisilla.
    A.3.2Name or abbreviated title of the trial where available
    LiraAAB18-30
    A.4.1Sponsor's protocol code numberNA
    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 SponsorRiitta Veijola
    B.1.3.4CountryFinland
    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 supportUniversity of Oulu
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oulu
    B.5.2Functional name of contact pointDept of Children and Adolescents
    B.5.3 Address:
    B.5.3.1Street AddressKajaanintie 50
    B.5.3.2Town/ cityOulu
    B.5.3.3Post code90029
    B.5.3.4CountryFinland
    B.5.4Telephone number+35883155129
    B.5.5Fax number+35883155559
    B.5.6E-mailriitta.veijola@oulu.fi
    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 AuthorisationFinland
    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 nameVictoza
    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.3.11 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
    Type 1 diabetes
    Tutkittavat ovat 18-30-vuotiaita aikuisia, joilla tyypin 1 diabetekseen johtava tautiprosessi on käynnissä, koska heidän seerumissaan on todettu vähintään kahdenlaisia betasoluspesifisiä autovasta-aineita. Pitkäaikaisissa prospektiivisissa seurantatutkimuksissa on todettu, että multippeleille betasoluspesifisille autovasta-aineille positiivisilla henkilöillä on 15 vuoden seurannassa erittäin suuri riski (84.2%) sairastua kliiniseen tyypin 1 diabetekseen (Ziegler et al. JAMA 2013;309:2473-9).
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes
    Tyypin 1 diabeteksessa potilaalle kehittyy henkeä uhkaava insuliinipuutos. Hoitona on pysyvä insuliinikorvaushoito. Suomessa tauti on yleisempi kuin muualla. Ehkäisevää hoitoa ei toistaiseksi ole.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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
    The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and glucose metabolism, and whether liraglutide treatment is tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.
    Tutkimuksen päätarkoitus on selvittää 18-30 vuotiailla aikuisilla, joilla tyypin 1 diabetekseen johtava tautiprosessi on käynnissä, parantaako liraglutidin päivittäinen käyttö insuliinin eritystä ja glukoosiaineenvaihduntaa, ja onko liraglutidin käyttö siedettyä ja turvallista.
    E.2.2Secondary objectives of the trial
    In addition, the effect of daily liraglutide treatment on immunological variables will be studied. The rate of progression to dysglycaemia and overt diabetes will also be closely monitored.
    Lisäksi tutkimuksen tarkoituksena on selvittää päivittäisen liraglutidihoidon vaikutus immunologisiin muuttujiin sekä sokeriaineenvaihdunnan heikkenemisen ja diabeteksen kehittymisen nopeuteen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subjects are 18-30 years of age, positive for at least 2 islet autoantibodies, have normal glucose tolerance in OGTT and are not pregnant.
    Tutkittavat ovat 18-30 vuotiaita, positiivisia vähintään kahdelle saarekesoluspesifiselle autovasta-aineelle, heillä on normaali sokerinsieto OGTT-kokeessa ja he eivät ole raskaana.
    E.4Principal exclusion criteria
    Principal exclusion criteria are:
    • type 1 diabetes
    • previous treatment in the last three months with any antidiabetic medication
    • impaired liver or kidney function
    • past or current history of pancreatitis
    • serum calcitonin value above normal (>50 ng/l)
    • presence of any chronic metabolic, hematologic or malignant disease
    • obesity BMI ≥30
    • pregnancy
    Pääasialliset poissulkukriteerit ovat:
    • tyypin 1 diabetes
    • diabeteslääkitys tutkimusta edeltävän kolmen kuukauden aikana
    • heikentynyt maksan tai munuaisten toiminta
    • sairastettu tai parhaillaan sairastettava haimatulehdus
    • seerumin normaalia korkeampi kalsitoniinipitoisuus (>50 ng/l)
    • krooninen aineenvaihduntasairaus, hematologinen sairaus tai pahanlaatuinen sairaus
    • lihavuus, BMI ≥30
    • raskaus
    E.5 End points
    E.5.1Primary end point(s)
    Primary end points (1-3) are:
    1) serum C-peptide area under the curve (AUC) during 2-hour OGTT
    2) first phase insulin response (FPIR = 1 + 3 min serum insulin) during 10-min IVGTT
    3) serum insulin AUC during 10-min IVGTT
    Pääasialliset vastemuuttujat (1-3) ovat:
    1) seerumin C-peptidin pitoisuuskäyrän alla oleva pinta-ala (area under the curve (AUC)) kaksi tuntia kestävässä OGTT-kokeessa
    2) varhainen insuliinivaste (FPIR = 1 + 3 min serum insulin) 10 minuuttia kestävässä IVGTT-kokeessa
    3) seerumin insuliinin AUC 10 minuuttia kestävässä IVGTT-kokeessa
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints for evaluation of primary end points (1-3) are:
    1) 2 weeks before start of treatment and 4 wk, and 4, 6, 9, 12, 18 and 24 months after start of treatment
    2) At the start of treatment and 2 mo, 6 mo + 2 wk, 12 mo + 2 wk and 24 mo + 2 wk after start of treatment
    3) At the start of treatment and 2 mo, 6 mo + 2 wk, 12 mo + 2 wk and 24 mo + 2 wk after start of treatment
    Mittausajankohdat pääasiallisille vastemuuttujille (1-3) ovat:
    1) 2 viikkoa ennen hoitokokeen alkua ja 4 vk sekä 4, 6, 9, 12, 18 ja 24 kuukautta hoidon alkamisen jälkeen
    2) Hoitokokeen alkaessa ja 2 kk, 6 kk + 2 vk, 12 kk + 2 vk ja 24 kk + 2 vk hoidon alkamisen jälkeen
    3) Hoitokokeen alkaessa ja 2 kk, 6 kk + 2 vk, 12 kk + 2 vk ja 24 kk + 2 vk hoidon alkamisen jälkeen
    E.5.2Secondary end point(s)
    Secondary end points (1-6) are:
    1) safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
    2) tolerability: frequency of gastrointestinal side effects (diarrhea, nausea, vomiting)
    3) plasma glucose variability during continuous glucose monitoring (CGM)
    4) HbA1c
    5) proportion of subjects diagnosed with dysglycemia or type 1 diabetes
    6) time to the development of dysglycemia or type 1 diabetes from the start of the trial drug
    Toissijaiset vastemuuttujat (1-6) ovat:
    1) turvallisuus: seerumin ja virtsan amylaasi, seerumin lipaasi, seerumin kalsitoniini, hypoglykemia
    2) siedettävyys: ruuansulatukseen liittyvien sivuvaikutusten (ripuli, pahoinvointi, oksentelu) frekvenssi
    3) plasman glukoosipitoisuuden vaihtelu jatkuvan glukoosiseurannan aikana (continuous glucose monitoring (CGM))
    4) HbA1c
    5) osuus tutkittavista, joilla diagnosoidaan sokeriaineenvaihdunnan heikkeneminen tai tyypin 1 diabetes
    6) aika sokeriaineenvaihdunnan heikkenemiseen tai tyypin 1 diabeteksen kehittymiseen hoitokokeen alkamisesta
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints for evaluation of secondary end points (1-6) are:
    1) 2 weeks before start of treatment, at the start of treatment, 4 wk, 2 months, 4 mo, 6 mo + 2 wk, 9 mo, 12 mo, 18 mo and 24 mo + 2 wk after start of treatment
    2) 1, 2, 3, 4 wk and 2, 4, 6, 9, 12, 18, 24 mo after start of treatment
    3) 2 wk before start of treatment and 6, 12 and 24 mo after start of treatment
    4) 2 wk before start of treatment and 4 wk, and 2, 4, 6, 9, 12, 18 and 24 mo after start of treatment
    5) 2 wk before start of treatment and 4 wk, and 4, 6, 9, 12, 18 and 24 mo after start of treatment
    6) 2 wk before start of treatment and 4 wk, and 4, 6, 9, 12, 18 and 24 mo after start of treatment
    Mittausajankohdat toissijaisille vastemuuttujille (1-6) ovat:
    1) 2 viikkoa ennen hoitokokeen alkua, hoidon alkaessa, 4 vk, 2kk, 4 kk, 6 kk + 2 vk, , 9, 12 ja 18 kk sekä 24 kk + 2 vk kuukautta hoidon alkamisen jälkeen
    2) 1, 2, 3, 4 vk ja 2, 4, 6, 9, 12, 18 ja 24 kk hoidon alkamisen jälkeen
    3) 2 vk ennen hoitokokeen alkua, 6, 12, ja 24 kk hoidon alkamisen jälkeen
    4) 2 vk ennen hoitokokeen alkua, 4 vk, 2, 4, 6, 9, 12, 18 ja 24 kk hoidon alkamisen jälkeen
    5) 2 vk ennen hoitokokeen alkua ja 4 vk, 4, 6, 9, 12, 18 ja 24 kk hoidon alkamisen jälkeen
    6) 2 vk ennen hoitokokeen alkua ja 4 vk, 4, 6, 9, 12, 18 ja 24 kk hoidon alkamisen jälkeen
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 concerned3
    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
    LVLS
    Viimeisen tutkittavan viimeinen tutkimuskäynti
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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: 42
    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 state42
    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)
    Possibility for follow-up in the local study center.
    Mahdollisuus seurantaan paikallisessa tutkimuskeskuksessa.
    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 Decision2015-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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