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    Summary
    EudraCT Number:2015-002084-42
    Sponsor's Protocol Code Number:EFC13957
    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:2016-04-20
    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 number2015-002084-42
    A.3Full title of the trial
    6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents age 6 - 17 Years with Type 1 Diabetes Mellitus with a 6-month Safety Extension Period
    Estudio de 6 Meses, Multicéntrico, Aleatorizado, Abierto, de 2 Brazos Paralelos, para Comparar Eficacia y Seguridad de una Nueva Formulación de Insulina Glargina y Lantus® Inyectado Una Vez al Día en Niños y Adolescentes entre 6-17 años con Diabetes Mellitus Tipo 1, con un Periodo de Extensión de Seguridad de 6 meses
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the Safety and Efficacy of HOE901-U300 with Lantus in Children and Adolescents with Type 1 Diabetes Mellitus
    Comparación de la Eficacia y Seguridad de una Nueva Formulación de Insulina Glargina (HOE901-U300) y Lantus® en Niños y Adolescentes con Diabetes Mellitus Tipo 1
    A.3.2Name or abbreviated title of the trial where available
    EDITION JUNIOR
    EDITION JUNIOR
    A.4.1Sponsor's protocol code numberEFC13957
    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 Sponsorsanofi-aventis recherche & développement
    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 supportsanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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 Toujeo
    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 nameInsulin glargine
    D.3.2Product code HOE901 - U300
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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 GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeHOE901 - U300
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.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 Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen
    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.3.4Pharmaceutical 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 INNINSULIN GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeHOE901
    D.3.9.4EV Substance CodeSUB08196MIG
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 diabetes mellitus
    Diabetes Mellitus tipo I
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes mellitus
    Diabetes Mellitus tipo I
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of HOE901-U300 to Lantus in terms of glycated hemoglobin (HbA1c)
    Comparar la eficacia de una nueva formulación de insulina glargina (HOE901-U300) con Lantus en cuanto al cambio de hemoglobina glucosilada A1c (HbA1c)
    E.2.2Secondary objectives of the trial
    -To compare HOE901-U300 and Lantus in terms of:
    -Percentage of patients reaching target HbA1c and fasting plasma glucose (FPG).
    -To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.
    Comparar HOE901-U300 y Lantus en cuanto al:
    - Porcentaje de pacientes que logran el valor deseado de HbA1c (<7,5 %) y en glucosa plasmática en ayunas
    - Evaluar la seguridad de HOE901-U300, incluyendo el análisis de episodios de hipoglucemia, episodios de hiperglucemia con cetosis y el desarrollo de anticuerpos antiinsulina;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Children and adolescents with type 1 diabetes mellitus (T1DM) for at least 1 year confirmed by typical symptoms at diagnosis and/or by antibody testing (presence of anti-GAD [glutamic acid decarboxylase] or anti-IA2 [islet antigen 2/tyrosine phosphatase] or anti-islet cell antibodies) and/or clinical features (eg, history of ketoacidosis).
    -Signed written informed consent obtained from parent(s)/legal guardian and written or oral assent obtained from patient.
    - Niños y adolescentes con DMT1 desde hace al menos 1 año confirmada por síntomas típicos en el momento del diagnóstico y/o por pruebas de anticuerpos (presencia de anticuerpos anti-GAD [glutamic acid decarboxylase (descarboxilasa del ácido glutámico)], o anti-IA2 [islet antigen 2/tyrosine phophatase (antígeno de islote-2/tirosina fosfatasa)] o anticuerpos contra las células de los islotes) y/o signos clínicos (p. ej., antecedentes de cetoacidosis);
    - Consentimiento informado por escrito firmado obtenido de su(s) padre(s)/tutor(es) legal(es) y asentimiento escrito u oral obtenido del paciente.
    E.4Principal exclusion criteria
    -Age <6 years and ?18 years.
    -Less than 1 year on insulin treatment prior to screening visit.
    -Less than 6 months on basal plus mealtime insulin and self-monitoring of blood glucose prior to screening visit.
    -Patients using premix insulins in the last 3 months before screening visit or patients using human regular insulin as mealtime insulin in the last 3 months before screening visit.
    -Use of an insulin pump in the last 6 months before screening visit or plans to switch to pump within the next 6 months after screening visit.
    -No willingness to inject insulin glargine (Lantus or HOE901 [U300]) once daily.
    -HbA1c <7.5% or >10% at screening.
    -Initiation of any glucose-lowering medications in the last 3 months before screening visit.
    -Hospitalization or care in the emergency ward for diabetic ketoacidosis or history of severe hypoglycemia (as defined by need for glucagon or IV glucose) and accompanied by seizure and/or unconsciousness and/or coma in the last 3 months prior to screening visit.
    -Postmenarchal girls not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy. Abstinence from sexual intercourse will be considered as an acceptable form of birth control.
    -Pregnant or breast-feeding adolescents, or adolescents who intend to become pregnant during the study period, or who are at risk of getting pregnant due to any psychosocial reason during the study period.
    - Edad inferior a 6 años y mayor o igual a 18 años;
    - Menos de 1 año de tratamiento con insulina antes de la visita de selección;
    - Menos de 6 meses con insulina basal más insulina prandial y autocontrol de la glucemia antes de la visita de selección;
    - Pacientes que utilizasen insulinas premezcladas en los últimos 3 meses antes de la visita de selección o pacientes que utilizasen insulina humana regular como insulina prandial en los últimos 3 meses antes de la visita de selección;
    - Uso de una bomba de insulina en los últimos 6 meses antes de la visita de selección o intención de cambiar a la bomba en los 6 meses siguientes a la visita de selección;
    - Falta de disposición para inyectar la insulina glargina (Lantus o HOE901-U300) una vez al día;
    - HbA1c <7,5 % o >10 % en la selección;
    - Inicio de cualquier medicación hipoglucemiante en los últimos 3 meses antes de la visita de selección;
    - Hospitalización o visita a urgencias por cetoacidosis diabética o antecedentes de hipoglucemia severa (definida por la necesidad de glucagón o glucosa intravenosa (i. v.)) y acompañada por convulsiones y/o inconsciencia y/o coma en los últimos 3 meses antes de la visita de selección;
    - Niñas posmenárquicas que no estén protegidas por método(s) anticonceptivo(s) de alta eficacia y/o que no estén dispuestas o a las que no se pueda realizar pruebas de embarazo. La abstinencia de relaciones sexuales se considerará una forma aceptable de anticonceptivo;
    - Adolescentes embarazadas o en periodo de lactancia o adolescentes que pretendan quedarse embarazadas durante el periodo de estudio o que estén en riesgo de quedarse embarazadas debido a cualquier motivo psicosocial durante el periodo de estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c
    Cambio desde la basal en HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline; Week 26
    Basal; semana 26
    E.5.2Secondary end point(s)
    1- Percentage of patients with HbA1c values of <7.5% without any episode of severe and/or documented (SMPG <54 mg/dL; 3.0 mmol/L) symptomatic hypoglycemia during the last 3 months of the main 6-month on-treatment period
    2- Change from baseline in FPG
    3- Percentage of patients with FPG of ?130 mg/dL (7.2 mmol/L) without any episode of severe and/or documented (SMPG ?54 mg/dL; 3.0 mmol/L) symptomatic hypoglycemia during the last 3 months of the main 6-month
    4- Change from baseline in 24-hour mean plasma glucose based on 8-point self-monitored plasma glucose (SMPG) profiles
    5- Change from baseline in variability of 24-hour mean plasma glucose based on 8-point SMPG profiles
    6- Number (%) of patients with hypoglycemia
    7- Number (%) of patients with hyperglycemia with ketosis
    8- Number (%) of patients with adverse events
    1-Porcentaje de pacientes con valores de HbA1c <7,5% en el mes6 en general y sin ningún episodio de hipoglucemia sintomática severa y/o documentada (SMPG <54mg/dl; 3,0mmol/l) durante los últimos3meses delperiodo principalde aleatorización (desde la fecha de aleatorizaciónhasta el mes 6 (visita 14), independientemente dela interrupción del tratamiento del estudio);
    2- Cambio desde el inicio en la glucosa plasmática en ayunas
    3- Porcentaje de pacientes con GPA ?130 mg/dl (7,2 mmol/l) en el mes 6 en general y sin ningún episodio de hipoglucemia sintomática severa y/o documentada (SMPG ?54 mg/dl; 3,0 mmol/l) durante los últimos 3 meses del periodo principal de aleatorización de 6 meses;
    4- Cambio en la glucosa plasmática media durante 24 horas basado en los perfiles de SMPG de 8 puntos desde la visita basal hasta el mes 6;
    5- Cambio en la variabilidad de la glucosa plasmática media durante 24 horas basado en los perfiles de SMPG de 8 puntos desde la visita basal hasta el mes 6;
    6- (%) de los pacientes con hipoglucemia
    7- (%) de los pacientes con hiperglucemia en cetosis
    8- (%) de pacientes con acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- Week 26
    2- Baseline; Week 26
    3- Week 26
    4- Baseline; Week 26
    5- Baseline; Week 26
    6- Up to Month 12
    7- Up to Month 12
    8- Up to Month 12
    1- Semana 26
    2- Basal; Semana 26
    3- Semana 26
    4- Basal; Semana 26
    5- Basal; Semana 26
    6- Hasta el mes 12
    7- Hasta el mes 12
    8- Hasta el mes 12
    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 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 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) Yes
    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 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.8.2.4Number 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 concerned5
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Canada
    Chile
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Latvia
    Mexico
    Poland
    Romania
    Russian Federation
    Spain
    United Kingdom
    United States
    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
    LVLS
    Última visita del último paciente
    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 months26
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months26
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 564
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 282
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 282
    F.1.2Adults (18-64 years) No
    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
    Children
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Child / adolescents
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 564
    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)
    None
    Ninguno
    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 Decision2016-05-24
    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 trial2018-12-20
    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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