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    Summary
    EudraCT Number:2007-006640-22
    Sponsor's Protocol Code Number:LANTU_C_02762
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-07-08
    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 number2007-006640-22
    A.3Full title of the trial
    Superioridad de insulina glargina Lantus frente a NPH: “Tratar hasta alcanzar la Normoglucemia”.
    Comparación del efecto de insulina glargina vs insulina NPH en pacientes con diabetes mellitus de tipo 2 no tratados previamente con insulina, que reciben al menos un antidiabético oral y no están bien controlados.
    A.3.2Name or abbreviated title of the trial where available
    LANTU_C_02762
    A.4.1Sponsor's protocol code numberLANTU_C_02762
    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
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    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.3.1Product nameinsulina glargina
    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.3.10 Strength
    D.3.10.1Concentration unit U/ml 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 Insuman Basal
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    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.3.1Product nameinsulina humana
    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 INNinsulin human
    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 mellitus de tipo 2
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049746
    E.1.2Term Insulin-requiring type II diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es demostrar la superioridad de insulina glargina con respecto a insulina NPH, en el cambio de la HbA1c con respecto al valor basal al terminar el periodo de tratamiento.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este estudio son comparar entre los grupos de tratamiento:

    • Glucosa plasmática (en ayunas, nocturna) en el tiempo,
    • Cambios con respecto al valor basal en la HbA1c en el tiempo,
    • Porcentaje de pacientes que alcanzan el objetivo de HbA1c < 7% y < 6,5% entre los dos grupos de tratamiento,
    • Uso de insulina prandial como medicación de rescate a los 6 meses,
    • Incidencia y tasa de hipoglucemia (sintomática diurna y nocturna, asintomática y severa),
    • Dosis diaria de insulina en cada visita,
    • Cambio del peso corporal con respecto al basal,
    • Evolución de los perfiles de 8 puntos de GP,
    • Seguridad global,
    • Resultados comunicados por el paciente (satisfacción con el tratamiento).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criterios de inclusión
    1. Edad entre 30 y 70 años, ambos inclusive,
    2. Diabetes mellitus de tipo 2 (DMT2) sin experiencia previa de tratamiento con insulina,
    3. DMT2 diagnosticada al menos hace 1 año,
    4. Tratado al menos con un ADO en dosis estables durante 3 meses como mínimo: la monoterapia o la combinación deben incluir metformina (dosis diaria de al menos 1700 mg), a menos que esté contraindicado o que sea mal tolerada,
    5. HbA1c ≥7,0% y < 9,0%,
    6. IMC < 40 kg/m2,
    7. Capacidad y disposición para realizar mediciones de glucosa plasmática en su domicilio, usando el glucómetro y el diario del paciente proporcionados por el promotor,
    8. Consentimiento informado obtenido por escrito en el momento de la inclusión en el estudio,
    9. Disposición y capacidad de cumplir con el protocolo del estudio.
    E.4Principal exclusion criteria
    Criterios de exclusión
    1. Tratamiento con agonistas del GLP-1 en los 3 meses previos al ingreso en el estudio,
    2. Tratamiento con inhibidores de la DPP-IV en los 3 meses previos al ingreso en el estudio,
    3. Diabetes mellitus que no es de tipo 2,
    4. Retinopatía proliferativa activa definida por fotocoagulación o vitrectomía en los 6 meses previos a la visita 1, o cualquier otra retinopatía inestable (que progrese rápidamente) que requiera fotocoagulación o tratamiento quirúrgico durante el estudio (tiene que haberse realizado un estudio del fondo del ojo en los 2 años anteriores a la entrada en el estudio),
    5. Alteración de la función renal: creatinina sérica ≥ 1,5 mg/dl (≥ 133 µmol/l) o ≥ 1,4 mg/dl (≥ 124 µmol/l) en hombres y mujeres, respectivamente,
    6. Antecedentes de sensibilidad a los fármacos del estudio o a otros fármacos que tengan una estructura química similar,
    7. Alteración de la función hepática (ALT o AST > 3 veces el límite superior de la normalidad),
    8. Embarazo o lactancia,
    9. Tratamiento con corticoesteroides sistémicos en los 3 meses previos a la admisión en el estudio o probabilidad de requerir tratamientos no permitidos durante el estudio,
    10. Tratamiento con un producto en investigación en los 30 días anteriores a la visita 1
    11. Abuso de alcohol o sustancias en el último año,
    12. Presencia de cualquier condición (médica, fisiológica, social o geográfica), actual o esperada, que, en opinión del investigador, pudiera poner en peligro la seguridad del paciente o el éxito de la participación del paciente mientras dure el estudio

    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia será el cambio de la HbA1c con respecto al valor basal al final del tratamiento.
    Los datos recogidos para evaluar los criterios de eficacia y seguridad son los siguientes:

    En momentos concretos:
    • HbA1c basal y en las semanas 12, 24 y 36,
    • Evaluación de la glucosa plasmática en ayunas medida por el paciente en 6 días consecutivos antes del basal y de las semanas 12, 24 y 36,
    • Durante la semana previa a la visita basal y en las semanas 12, 24 y 36 los pacientes registrarán un perfil de glucosa plasmática de 8 puntos dos veces a la semana (cuando mejor les convenga): inmediatamente antes y 2 horas después del desayuno, la comida y la cena, al acostarse y a las 3:00 de la madrugada antes de empezar el tratamiento con insulina, y 5 ó 6 horas después de la inyección de insulina durante la fase de tratamiento. Para ajustar la dosis de insulina se usarán uno o ambos valores nocturnos,
    • Necesidad de añadir insulina prandial en el mes 6,
    • El peso corporal en la visita basal y en las semanas 4, 8, 12, 24 y 36.
    • Dosis diarias de insulina en cada visita,
    • Perfil lipídico basal y en la semana 36,
    • Resultados comunicados por el paciente: La satisfacción con el tratamiento se valorará usando el cuestionario DTSQs en la visita basal y en las 12, 24 y 36 y el DTSQc en la semana 36,
    • Constantes vitales en cada visita.

    En todo el estudio:
    • Episodios de hipoglucemia,
    • Acontecimientos adversos.
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months23
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months23
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 239
    F.4.2.2In the whole clinical trial 670
    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 Decision2008-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-31
    P. End of Trial
    P.End of Trial StatusOngoing
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