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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-005125-12
    Sponsor's Protocol Code Number:LIRALUNG
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-005125-12
    A.3Full title of the trial
    MULTICENTRE RANDOMIZED DOUBLE BLIND, CROSSOVER, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF LIRAGLUTIDE ON LUNG FUNCTION IN PATIENTS WITH TYPE 2 DIABETES MELLITUS (LIRALUNG STUDY)
    ESTUDIO MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CRUZADO Y CONTROLADO CON PLACEBO PARA EVALUAR EL EFECTO DE LIRAGLUTIDA SOBRE LA FUNCIÓN PULMONAR DE PACIENTES CON DIABETES MELLITUS TIPO 2 (ESTUDIO LIRALUNG)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY TO ASSESS THE EFFICACY OF LIRAGLUTIDE ON LUNG FUNCTION IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
    ESTUDIO PARA EVALUAR EL EFECTO DE LIRAGLUTIDA SOBRE LA FUNCIÓN PULMONAR DE PACIENTES CON DIABETES MELLITUS TIPO 2
    A.3.2Name or abbreviated title of the trial where available
    LIRALUNG
    LIRALUNG
    A.4.1Sponsor's protocol code numberLIRALUNG
    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 SponsorDr. Albert Lecube, Ph.D., M.D.
    B.1.3.4CountrySpain
    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 Pharma S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science S.L.
    B.5.2Functional name of contact pointDepartamento de Operaciones
    B.5.3 Address:
    B.5.3.1Street AddressC/Sant Antoni María Claret, 434
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08027
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914561105
    B.5.5Fax number0034914561126
    B.5.6E-mailraul.m@dynasolutions.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 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 nameLiraglutida
    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.3.9.3Other descriptive nameVictoza
    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
    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
    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 2 Diabetes
    Diabetes tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes
    Diabetes tipo 2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of treatment with liraglutide versus placebo on forced expiratory volume in one second (FEV1) in patients with type 2 diabetes mellitus
    Evaluar el efecto del tratamiento con liraglutida frente a placebo sobre el volumen espiratorio forzado en el primer segundo (FEV1) en pacientes con diabetes mellitus tipo 2
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of treatment with liraglutide versus placebo on various other related respiratory function parameters
    - To evaluate the effect of treatment with liraglutide versus placebo on respiratory parameters during sleep
    - To evaluate the effect of treatment with liraglutide versus placebo on serum proteins A and D of pulmonary surfactant
    - Evaluar el efecto del tratamiento con liraglutida frente a placebo sobre otros parámetros relacionados con la función respiratoria distintos a FEV1
    - Evaluar el efecto del tratamiento con liraglutida frente a placebo sobre los parámetros respiratorios durante el sueño.
    - Evaluar el efecto del tratamiento con liraglutida frente a placebo sobre los niveles séricos de las proteínas A y D del surfactante pulmonar
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed informed consent.
    Subjects between 40 and 65 years old.
    Diagnosis of type 2 diabetes mellitus with more than 5 years of evolution of disease.
    Metformin ( alone or in combination with sulfonylurea and / or insulin and / or tiazolidinendionas ) at a stable dose for at least the past 3 months.
    HbA1c ? 7,0 y ? 9,0 %.
    BMI between 30 and 40 kg / m2.
    No pulmonary disease (COPD, asthma, fibrosis, etc) known.
    Baseline FEV1 decline of equal or greater than 10% in the percentage of the theoretical value.
    Chest radiography without significant changes in the lung parenchyma .
    Pacientes que firman el consentimiento informado para participar en el
    estudio
    Edad entre 40 y 65 años.
    Diagnóstico de diabetes mellitus tipo 2 con más de 5 años de evolución de enfermedad.
    Tratamiento con metformina (en monoterapia o en combinación con sulfonilureas y/o insulina y/o tiazolidinendionas) a una dosis estable durante al menos los 3 meses anteriores.
    HbA1c ? 7,0 y ? 9,0 %.
    Índice de masa corporal entre 30 y 40 Kg/m2.
    Sin patología pulmonar (EPOC, asma, fibrosis, etc) conocida.
    Descenso basal del FEV1 igual o superior al 10 % en el porcentaje del valor teórico.
    Radiografía de tórax sin alteraciones significativas en el parénquima pulmonar.
    E.4Principal exclusion criteria
    Type 1 diabetes mellitus
    Treatment with inhibitors of dipeptidyl peptidase 4 glitazones and / or SGLT2 inhibitors.
    Active and former smokers for less than five years ago smoking.
    Chronic obstructive pulmonary disease.
    Respiratory sleep disorders that require treatment with CPAP (continuous positive pressure in the airway).
    Asthma treatment with bronchodilators.
    Previous bariatric surgery.
    Cardiovascular disease, heart failure and / or stroke.
    Pathology of the chest wall.
    Serum creatinine> 1.7 mg / dl.
    Abnormal results in liver function test (ALT / AST greater than twice the upper limit of normal).
    History of acute or chronic pancreatitis.
    Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia (MEN ) type 2.
    Active neoplasms or neoplastic patients considered disease-free history from less than 5 years ago.
    Women of childbearing age who are pregnant (positive pregnancy test within 14 days before the start of treatment) or intend to get pregnant.
    Lactating women.
    Women of childbearing potential not using adequate contraception (such as oral contraceptives, intrauterine device or barrier method of birth control along with spermicide or surgical sterilization) or unwilling to use during the study (as required by local laws or practices).
    Diabetes mellitus tipo 1.
    Tratamiento con inhibidores de dipeptidil peptidasa 4, glitazonas y/o inhibidores de SGLT2.
    Fumadores activos y ex fumadores desde hace menos de 5 años.
    Enfermedad obstructiva pulmonar crónica.
    Trastornos respiratorios del sueño que precisen de tratamiento con CPAP (presión positiva continua en la vía aérea).
    Asma en tratamiento con broncodilatadores.
    Cirugía bariátrica previa.
    Enfermedad cardiovascular, insuficiencia cardiaca y/o ictus.
    Patología de la pared torácica.
    Creatinina sérica > 1,7 mg/dl.
    Resultado anormal en la prueba de función hepática (valores de ALT/AST mayores de dos veces el límite superior de la normalidad).
    Antecedentes de pancreatitis aguda o crónica.
    Antecedentes personales o familiares de cáncer medular tiroideo o Neoplasia Endocrina Múltiple (MEN) tipo 2.
    Neoplasias activas o pacientes con antecedente neoplásico considerado libre de enfermedad desde hace menos de 5 años.
    Mujeres en edad fértil que están embarazadas (test de embarazo positivo en los 14 días antes del inicio del tratamiento) o que desean quedarse embarazadas.
    Mujeres en periodo de lactancia.
    Mujeres en edad fértil que no utilizan métodos anticonceptivos adecuados (como anticonceptivos orales, dispositivo intrauterino o método de barrera anticonceptivo junto con espermicida o esterilización quirúrgica) o no estén dispuestos a utilizarlos durante el estudio (según lo requieren las leyes o prácticas locales).
    E.5 End points
    E.5.1Primary end point(s)
    Forced expiratory volume in one second (FEV1)
    Volumen espiratorio forzado en el primer segundo (FEV1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Basal / screening visit
    Visit during the treatment period in weeks 11 and 18
    l
    Visita basal/screening
    Visita durante el periodo de tratamiento en las semanas 11 y 18
    E.5.2Secondary end point(s)
    Other parameters derived from spirometry:
    - Forced vital capacity (FVC,)
    - Maximum average expiratory flow (FEF 25-75)
    - FEV1 / FVC

    Parameters derived from measurements of static lung volumes:
    - Residual volume (RV)
    - Total lung capacity (TLC)
    - Residual functional capacity (RFC, its acronym in English)

    Transfer factor of the lung for carbon monoxide (DLCO)

    6-minute walk test

    Parameters of an unassisted home respiratory polygraphy:
    - Apnea-hypopnea index
    - Percentage of accumulated time with oxygen saturation less than 90% (TA90).

    Serum surfactant protein A and D in serum.
    Otros parámetros derivados de la espirometría forzada:
    - Capacidad vital forzada (FVC, de sus siglas en inglés)
    - Flujos espiratorios medio máximo (FEF25-75)
    - Cociente FEV1/FVC

    Parámetros derivados de las mediciones de volúmenes pulmonares estáticos:
    - Volumen residual (RV, de sus siglas en inglés)
    - Capacidad pulmonar total (TLC, de sus siglas en inglés)
    - Capacidad funcional residual (RFC, de sus siglas en inglés)

    Factor de transferencia del pulmón para monóxido de carbono (TLCO, de sus siglas en inglés)

    Datos de la prueba de marcha de 6 minutos

    Parámetros de una poligrafía respiratoria domiciliaria no asistida:
    - Índice de apnea-hipopnea
    - Porcentaje de tiempo acumulado con saturaciones de oxígeno menores de 90% (TA90).

    Niveles séricos de la proteína surfactante A y D en suero.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Basal / screening visit
    Visit during the treatment period in weeks 2, 7, 13 and 18
    Visit end of treatment or early withdrawal
    Visita basal/screening
    Visita durante el periodo de tratamiento en las semanas 2, 7, 13, 13 y 18
    Visita final de tratamiento o de abandono prematuro
    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 Yes
    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 No
    E.8.1.6Cross over Yes
    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 concerned6
    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
    Visit end of treatment or early withdrawal
    Visita final de tratamiento o de abandono prematuro
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 76
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with legal representative
    Pacientes con representante legal
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state76
    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)
    According to standard clinical care
    Según práctica clínica habitual
    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 Decision2016-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-16
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