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    Summary
    EudraCT Number:2010-018437-21
    Sponsor's Protocol Code Number:LANTU_C_03680
    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:2010-04-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-018437-21
    A.3Full title of the trial
    Estudio comparativo, multicéntrico, internacional, aleatorizado (1:1), abierto, de grupos paralelos y 24 semanas de duración, de insulina glargina frente a liraglutida en pacientes con diabetes tipo 2 sin insulinoterapia previa, tratados con fármacos orales y no controlados suficientemente, seguido de un período de extensión de 24 semanas con insulina glargina para los pacientes que no hayan conseguido un control adecuado con liraglutida”
    "A 24-week, multicenter, international, randomized (1:1), parallel-group, open-label, comparative study of insulin glargine versus liraglutide in insulin-naïve patients with Type 2 diabetes treated with oral agents and not adequately controlled, followed by a 24-week extension period with insulin glargine for patients not adequately controlled with liraglutide"
    A.3.2Name or abbreviated title of the trial where available
    EAGLE (Efficacy Assessment of insulin Glargine versus LiraglutidE after oral agents failure)
    A.4.1Sponsor's protocol code numberLANTU_C_03680
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSANOFI AVENTIS GROUPE
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 LANTUS 100 Unidades/ml solución inyectable en pluma precargada
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS DEUTSCHLAND GMBH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNINSULINA GLARGINA
    D.3.9.1CAS number 160337-95-1
    D.3.9.3Other descriptive nameINSULIN GLARGINE
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 solución inyectable en pluma precargada
    D.2.1.1.2Name of the Marketing Authorisation holderNOVO NORDISK A/S
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNLIRAGLUTIDA
    D.3.9.3Other descriptive nameLIRAGLUTIDA
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetes tipo 2 no adecuadamente controlada
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11
    E.1.2Level LLT
    E.1.2Classification code 10063624
    E.1.2Term Diabetes melitus tipo II inadecuadamente controlada
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar la superioridad de la insulina glargina frente a liraglutida en términos de porcentaje de pacientes que alcanzan un nivel de HbA1c < 7% al final del período comparativo en pacientes con diabetes de tipo 2 no controlados con intervenciones en el estilo de vida y fármacos orales
    E.2.2Secondary objectives of the trial
    Analizar el efecto de la insulina glargina en comparación con la liraglutida sobre los siguientes parámetros:
    - Nivel de HbA1c.
    - Porcentaje de pacientes cuya HbA1c ha disminuido pero que sigue siendo &#8805; 7% al final del período comparativo.
    - Porcentaje de pacientes cuya HbA1c ha aumentado al final del período comparativo.
    - Glucosa plasmática en ayunas (GPA).
    - Perfiles de glucosa plasmática (GP) de 7 puntos.
    - Aparición de hipoglucemia.
    - Peso.
    - Acontecimientos adversos.
    - Resultados notificados por el paciente (RNP). DTSQs, DTSQc y ADDQoL.
    - Costes del tratamiento específicos de la diabetes.

    Objetivos del período de extensión:
    Analizar el efecto de la insulina glargina en pacientes no controlados adecuadamente con liraglutida sobre los siguientes parámetros:
    - Nivel de HbA1c.
    - GPA.
    - Perfiles de GP de 7 puntos.
    - Aparición de hipoglucemia.
    - Peso.
    - Acontecimientos adversos.
    - RNPs: DTSQs, DTSQc y ADDQoL.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criterios de inclusión periodo comparativo:
    -Pacientes entre 35 y 75 años, inclusive.
    -Con diabetes de tipo 2 diagnosticada hace al menos 1 año.
    -Tratados con intervenciones en el estilo de vida y metformina a la dosis máxima tolerada (con una dosis diaria mínima de 1 g), sola o en combinación con un secretagogo de insulina oral (sulfonilurea, glinida o inhibidor de la DPP-IV), durante más de 3 meses.
    -7,5% < HbA1c menor o igual a 12%.
    -IMC entre 25 y 40 kg/m2, inclusive.
    -Capacidad y disposición para realizar el autocontrol de la GP con el medidor de glucosa suministrado por el promotor y rellenar el diario del paciente.
    -Disposición y capacidad para cumplir el protocolo del estudio.
    -Consentimiento informado firmado antes de iniciar cualquier procedimiento del estudio.

    Criterios de inclusión periodo extensión
    -Pacientes aleatorizados en el grupo de liraglutida que hayan completado el período comparativo de 24 semanas.
    -HbA1c mayor o igual a 7 %.
    -Dosis de metformina de acuerdo con los criterios de inclusión de la visita 1 (es decir, dosis máxima tolerada, con dosis diaria mínima de 1 g) y que se haya mantenido estable durante el período comparativo.
    E.4Principal exclusion criteria
    Criterios exlusión periodo comparativo
    - Tratamiento previo con análogos GLP-1 o insulina (excepto el tratamiento de la diabetes gestacional o el tratamiento ocasional con insulina durante menos de 1 semana).
    -Tratamiento con tiazolidindionas o inhibidores de la alfa-glucosidasa durante los 3 meses anteriores a la entrada en el estudio.
    -Diabetes que no sea diabetes de tipo 2 (p. ej., secundaria a trastornos pancreáticos, ingesta de fármacos o agentes químicos…).
    -Mujeres embarazadas (las mujeres en edad fértil deberán tener una prueba de embarazo negativa al entrar en el estudio y utilizar un método anticonceptivo aprobado médicamente).
    -Mujeres lactantes.
    -Pacientes hospitalizados (excepto hospitalizaciones para revisiones rutinarias de la diabetes).
    -Retinopatía proliferativa activa, definida por fotocoagulación o vitrectomía en los 6 meses anteriores a la entrada en el estudio, o cualquier otra retinopatía inestable (de progresión rápida) que pueda requerir fotocoagulación o tratamiento quirúrgico durante el estudio, documentada por una exploración de la retina realizada durante los 2 años anteriores a la entrada en el estudio.
    -Deterioro de la función renal (aclaramiento de creatinina < 60 ml/min).
    -Deterioro de la función hepática (ALT, AST > o = 2,5 veces el límite superior de normalidad).
    -Antecedentes personales o familiares de carcinoma medular de tiroides.
    -Síndrome de neoplasia endocrina múltiple de tipo 2.
    -Enfermedad gastrointestinal grave (incluidas enfermedad inflamatoria intestinal y gastroparesia diabética).
    -Insuficiencia cardiaca congestiva.
    -Antecedentes de pancreatitis aguda.
    -Tratamiento con corticoesteroides con acción sistémica potencial en los 3 meses previos a la entrada en el estudio.
    -Abuso de alcohol o drogas en los últimos 5 años.
    -Antecedentes de sensibilidad a los fármacos del estudio o a fármacos con estructura química similar.
    -Trabajadores de turno de noche
    -Presencia de cualquier situación (médica, psicológica, social o geográfica), actual o prevista, que pueda comprometer la seguridad del paciente o limitar el éxito de su participación en el estudio.

    Criterios de exclusión periodo de extensión
    -Tratamiento con antidiabéticos orales que no sean metformina y la sulfonilurea habitual del paciente, si la toma, o insulina durante el período comparativo (excepto en caso de emergencia, durante un período inferior a 7 días).
    -Tratamiento con corticoesteroides con acción sistémica potencial en los últimos 3 meses del período comparativo.
    -Mujeres embarazadas (las mujeres en edad fértil deberán tener una prueba de embarazo negativa al entrar en el período de extensión y utilizar un método anticonceptivo aprobado médicamente.
    -Mujeres lactantes.
    -Pacientes hospitalizados (excepto hospitalizaciones para revisiones rutinarias de la diabetes).
    -Retinopatía proliferativa activa, definida por fotocoagulación o vitrectomía durante el período comparativo, o cualquier otra retinopatía inestable (de progresión rápida) que pueda requerir fotocoagulación o tratamiento quirúrgico durante el período de extensión.
    -Deterioro de la función renal (aclaramiento de creatinina < 60 ml/min).
    -Deterioro de la función hepática (ALT, AST mayor o igual a 2,5 veces el límite superior de normalidad).
    - Antecedentes de sensibilidad a insulina glargina
    E.5 End points
    E.5.1Primary end point(s)
    El criterio principal será el porcentaje de pacientes que alcancen una HbA1c < 7% al final del período comparativo (semana 24).
    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 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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Calidad de vida
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    Seguido de un periodo de extensión de 24 semanas
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA91
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state84
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 590
    F.4.2.2In the whole clinical trial 930
    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 Decision2010-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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