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    Summary
    EudraCT Number:2009-018172-33
    Sponsor's Protocol Code Number:LANTU_C_04589
    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:2010-05-25
    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 number2009-018172-33
    A.3Full title of the trial
    Estudio de 24 semanas de duración, multicéntrico, abierto y comparativo de dos estrategias (insulina glargina frente a insulina premezclada) para el tratamiento de pacientes con diabetes de tipo 2 que han fracasado a los fármacos orales

    A 24-week, open, multicenter, comparative study of 2 strategies (including insulin glargine versus premixed insulin) for the therapeutic management of patients with type 2 diabetes failing oral agents
    A.3.2Name or abbreviated title of the trial where available
    GALAPAGOS
    A.4.1Sponsor's protocol code numberLANTU_C_04589
    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 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 APIDRA 100 Unidades/ml,solostar 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 GLULISINA
    D.3.9.3Other descriptive nameINSULIN GLULISINE
    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: 3
    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 NOVOMIX 30 Flexpen 100 U/ml, suspensión inyectable en una 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 Suspension 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 ASPARTA
    D.3.9.3Other descriptive nameINSULIN ASPART
    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.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 con fracaso a las intervenciones en el estilo de vida y a los fármacos orales
    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 una estrategia con insulina glargina en comparación con una estrategia con insulina premezcla en cuanto a porcentaje de pacientes que consiguen un valor de HbA1c inferior al 7% al final del período de tratamiento sin experimentar hipoglucemia sintomática documentada (confirmada por glucosa plasmática [GP] &#8804; 56 mg/dl (3,1 mmol/l) durante el período de tratamiento, en pacientes con diabetes de tipo 2 en los que el tratamiento con estilo de vida y fármacos orales ha fracasado
    E.2.2Secondary objectives of the trial
    Evaluar el efecto de la insulina glargina en comparación con la insulina premezcla en:
    -Evolución de los niveles de HbA1c durante el período de tratamiento
    -Porcentaje de pacientes que logran el objetivo de HbA1c < 7 % y que no experimentan hipoglucemia sintomática documentada, confirmada por una GP &#8804; 70 mg/dl (3,9 mmol/l)
    -Porcentaje de pacientes que logran el objetivo de HbA1c < 6,5% y que no experimentan hipoglucemia sintomática documentada, confirmada por una GP &#8804; 56 mg/dl (3,1 mmol/l)
    -Porcentaje de pacientes que logran el objetivo de HbA1c < 6,5% y que no experimentan hipoglucemia sintomática documentada, confirmada por una GP &#8804; 70 mg/dl (3,9 mmol/l)
    -Evolución de la glucosa plasmática en ayunas
    -Evolución de los perfiles de glucosa plasmática de 7 puntos
    -Evolución del peso
    -Aparición de hipoglucemia
    -Dosis de insulinas
    -Evolución de la función hepática
    - Resultados notificados por el paciente (RNP): cuestionarios DTSQs y DTSQc
    -Seguridad global
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Hombres o mujeres &#8805; 35 años
    • Con diabetes de tipo 2 diagnosticada hace más de un año.
    • No tratados previamente con insulina.
    • Tratados con intervenciones en el estilo de vida y antidiabéticos orales, al menos metformina a la dosis máxima tolerada (con una dosis mínima de 1 g/día) durante un mínimo de 3 meses.
    • HbA1c &#8805; 7,0 % y &#8804; 10,5%
    • IMC &#8804; 40 kg/m2
    • Capacidad y disposición para realizar una monitorización de la glucosa plasmática (GP) mediante el glucómetro entregado por el promotor y rellenar el diario del paciente.
    • Disposición y capacidad para cumplir con el protocolo de estudio.
    • Consentimiento informado firmado obtenido antes de cualquier procedimiento del estudio.
    E.4Principal exclusion criteria
    • Tratamiento con agonistas GLP-1 en los 3 meses previos a la entrada en el estudio.
    • Tratamiento previo con insulina (excepto para el tratamiento de la diabetes gestacional o tratamiento ocasional con insulina durante menos de 1 semana).
    • Diabetes que no sea de tipo 2 (p. ej., diabetes de tipo 1, diabetes secundaria a trastornos pancreáticos, uso de fármacos o sustancias químicas,…).
    • Mujeres embarazadas o en período de lactancia
    • Paciente hospitalizado (excepto para un examen rutinario de la diabetes)
    • Retinopatía proliferativa activa, definida por fotocoagulación o vitrectomía en los 6 meses previos 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 exploración de la retina, en los 2 años previos a la entrada en el estudio.
    • Antecedentes de sensibilidad a los fármacos del estudio o fármacos de estructura química similar.
    • Alteración de la función renal: aclaramiento de creatinina < 60 mL/min
    • Alteración de la función hepática (ALT, AST > 3 veces el límite superior de normalidad).
    • Enfermedad gastrointestinal grave
    • 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 5 últimos años
    • Trabajador 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
    E.5 End points
    E.5.1Primary end point(s)
    El criterio principal de eficacia será el porcentaje de pacientes con un valor de HbA1c < 7% al final del período de tratamiento, sin hipoglucemia sintomática documentada (confirmada por una GP menor o igual a 56 mg/dl) en el período de tratamiento de 24 semanas.
    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 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 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 No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 278
    F.4.2.2In the whole clinical trial 870
    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 Decision2010-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
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