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    Summary
    EudraCT Number:2008-001249-24
    Sponsor's Protocol Code Number:BC21587
    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:2009-01-19
    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 number2008-001249-24
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, abierto, controlado con grupos activos, para comparar la eficacia, seguridad y tolerancia de taspoglutida (RO5073031) frente a insulina glargina en pacientes con diabetes de tipo 2 no tratados antes con insulina y controlados inadecuadamente con un tratamiento de combinación con metformina y sulfonilurea.
    A multi-center, double-blind, randomized, parallel group, placebo-controlled 12-week study to investigate glycemic parameters of efficacy, safety/ tolerability and pharmacokinetics of five dose levels of RO4998452 in patients with type 2 diabetes mellitus
    A.4.1Sponsor's protocol code numberBC21587
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 No
    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 nameSGLT2 co-transporter inhibitor
    D.3.2Product code RO4998452
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSGLT2 co-transporter inhibitor
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeRO4998452/F02
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeselective inhibitor of the sodium glucose co-transporter 2 (SGLT2)
    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 No
    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 nameSGLT2 co-transporter inhibitor
    D.3.2Product code RO4998452
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSGLT2 co-transporter inhibitor
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeRO4998452/F03
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeselective inhibitor of the sodium glucose co-transporter 2 (SGLT2)
    D.IMP: 3
    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 No
    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 nameSGLT2 co-transporter inhibitor
    D.3.2Product code RO4998452
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSGLT2 co-transporter inhibitor
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeRO4998452/F04
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeselective inhibitor of the sodium glucose co-transporter 2 (SGLT2)
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetes mellitus tipo 2
    Type 2 diabetes mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term 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
    Determinar la variación absoluta en la concentración de HbA1c desde la situación basal hasta el final del periodo de tratamiento en comparación con el placebo.
    E.2.2Secondary objectives of the trial
    Determinar los parámetros adicionales de eficacia, seguridad y tolerancia tras la administración de RO4998452 frente al placebo, incluyendo
    - la variación absoluta en la glucemia en ayunas desde la situación basal hasta el final del periodo de tratamiento
    - La respuesta glucémica con parámetros adicionales del control de la glucemia (tal como glucosa en sangre media diaria obtenida del perfil de glucosa en plasma de 7 puntos, fructosamina, prueba de tolerancia al alimento)
    - el perfil de tolerabilidad y de seguridad
    - los efectos sobre el peso corporal
    - La farmacocinética y la relación exposición-respuesta de RO4998452, incluida la influencia de las covariables (mediante análisis poblacional)
    Objetivos exploratorios:
    Determinar
    - Los efectos sobre la sensación de hambre y de sed
    - La curva dosis-respuesta de RO4998452 sobre la excreción de glucosa en orina de 24 h
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocolo BC21587RG: Proyecto de investigación del banco de muestras de Roche asociado al protocolo principal BC21587 . Versión A 13-Octubre-200 (castellano de fecha 28-Noviembre-2008).
    E.3Principal inclusion criteria
    - Pacientes con diagnóstico de diabetes de tipo 2 al menos 3 meses antes de la exploración de selección, según los criterios de la OMS
    - Pacientes que han recibido tratamiento con
    (1) dieta y ejercicio y una dosis estable de metformina (dosis diaria de 1,5 g a 3,0 g, pero no superior a la recomendada en la indicación aprobada localmente) durante al menos 3 meses o
    (2) con dieta y ejercicio
    - HbA1c mayor o igual que 7,0 % y menor o igual que 10,0 % en el periodo de selección y en la visita previa a la aleatorización
    - 18-75 años de edad (ambas incluidas) en el momento de la selección
    - IMC mayor que 22 kg/m2 y menor o igual que 45 kg/m2 en la visita de selección
    - Capaz y dispuesto a dar el consentimiento informado escrito y capaz para cumplir de forma independiente todos los requisitos del estudio
    E.4Principal exclusion criteria
    - Pacientes con diabetes mellitus de tipo 1
    - Antecedentes de cetoacidosis o acidosis láctica
    - Niveles séricos de péptico C en ayunas menor o igual que 1 ng/ml en la visita de selección para pacientes con un IMC menor o igual que 25 kg/m2
    - Glucosa plasmática en ayunas > 240 mg/dl (13,3 mmol/l)
    - Cualquier contraindicación de metformina, tal y como se figure en la indicación como, por ejemplo, insuficiencia cardíaca congestiva (clase III o IV de la NYHA, que requieren tratamiento farmacológico) o insuficiencia respiratoria
    - Antecedentes de cambios en el peso corporal en los 3 meses anteriores a la selección > 10% del peso corporal medido en la visita de selección
    - Pacientes tratados actualmente, o en los 12 meses anteriores a la visita de selección, con insulina (con la excepción de situaciones de emergencia en las que se administró insulina durante < 7 días consecutivos)
    - Pacientes tratados actualmente, o en los 2 meses anteriores a la visita de selección, con un agente antidiabético oral o inyectable, a excepción de dosis estables de metformina
    - Pacientes tratados actualmente, o en los 6 meses anteriores a la visita de selección, con cualquier agonista del PPAR gamma;
    - Antecedentes de tratamiento antidiabético triple
    - Pacientes tratados actualmente, o en los 4 meses anteriores a la visita de selección, con cualquier medicación adelgazante de prescripción facultativa u orlistat
    - Pacientes tratados con fármacos modificadores de lipoproteínas (p. ej., niacina, estatina) si la dosis o la pauta posológica se cambió en las 4 semanas anteriores a la selección. Las dosis y las pautas posológicas para fibratos deben ser estables durante 3 meses antes de la selección.
    - Pacientes en tratamiento con medicación antihipertensora y/u hormonas tiroideas si la(s) dosis no han estado estables durante al menos 4 semanas antes de la aleatorización
    - Tratamiento con corticosteroides sistémicos, inhalados o tópicos durante > 14 días en los 3 meses anteriores a la visita de selección
    - Alteración de la función hepática (sugerida por los niveles de ALT, AST, bilirrubina total o fosfatasa alacalina > 2,5 LSN) en la visita de selección
    - Hiponatremia (< 120 mM) o hipernatremia (> 150 mM) en la visita de selección o en los 3 meses anteriores a la visita de selección
    - Enfermedad renal o disfunción renal (sugerido por niveles de creatinina en suero iguales o mayores que 1,5 mg/dl (133 µmol/l) [varones], mayores o iguales que 1,4 mg/dl (124 µmol/l) [mujeres]) en la visita de selección
    - Antecedentes personales o familiares de glucosuria renal (= glucosuria en ausencia de diabetes mellitus)
    - Antecedentes de cirugía bariátrica o de resección del intestino delgado
    - Antecedentes de hipertensión no controlada (PAS > 150 mmHg y/o PAD > 95 mmHg, a pesar del tratamiento), < 3 meses antes de la selección
    - Infarto de miocardio o ictus en los 6 meses anteriores a la selección
    - Signos de complicación diabética significativa pre-diagnosticada que requiere tratamiento médico (p. ej., gastroparesia médicamente tratada, diagnóstico de retinopatía diabética proliferativa)
    - Cualquier enfermedad grave conocida (como cáncer, infección importante activa, trastornos psiquiátricos graves, trastorno gatrointestinal significativo clínico, enfermedad autoinmunitaria crónica, anemia crónica, todas las hemoglobinopatías) en la visita de selección que puedan interferir en la realización del estudio
    - Cualquier enfermedad nueva diagnosticada en la visita de selección, que requiera tratamiento durante más de 10 días o tratamientos crónicos que no puedan estabilizarse durante el periodo de selección
    - Toda anomalía en los análisis clínicos o ECG (p. ej., prolongación clínicamente significativa del QTc, antecedentes familiares de síndrome del QT largo, uso concomitante de antiarrítmicos de clase I tales como disopiramida, quinidina, procainamida, mexiletina, flecainida, propafenona) que, según el criterio del investigador, impida su participación segura en el estudio
    - Participación en un estudio con fármaco en fase de investigación en los 2 meses (o cinco semividas, lo que sea más largo) anteriores a la selección
    - Mujeres embarazadas o lactantes, con una prueba de embarazo positiva y mujeres en edad fértil que no estén utilizando dos métodos anticonceptivos adecuados, incluido un método de barrera
    - Antecedentes de alcoholismo o toxicomanía
    - Hipersensibilidad conocida a RO4998452 o a cualquiera de los componentes de su formulación
    - Personas con albinismo
    E.5 End points
    E.5.1Primary end point(s)
    Cambio absoluto de la HbA1c desde el valor basal hasta el valor del final del periodo de tratamiento.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    biomarker research
    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) 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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    The end of the trial is defined as the last visit of the last patient in the trial (LPLV).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 103
    F.4.2.2In the whole clinical trial 300
    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)
    There are no plans for treatment or medical supervision of the patients after the end of the trial. It will be left at the discretion of the Investigator to continue the original metformin monotherapy, or to initiate a monotherapy or combination therapy, after completion of the treatment period. The physician in charge of the patient should closely monitor glycemia levels during the transition period.
    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 Decision2009-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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