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    Summary
    EudraCT Number:2012-004096-38
    Sponsor's Protocol Code Number:EFC12626
    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:2012-12-21
    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 number2012-004096-38
    A.3Full title of the trial
    A randomized, open-label, active-controlled, 3-arm parallel-group, 26-week study comparing the efficacy and safety of lixisenatide to that of insulin glulisine once daily and insulin glulisine three times daily in patients with Type 2 diabetes insufficiently controlled with insulin glargine with or without metformin
    Estudio aleatorizado, abierto, controlado con fármaco activo, con 3 brazos de grupos paralelos, de 26 semanas que compara la eficacia y seguridad de lixisenatida con la de insulina glulisina una vez al día y la de insulina glulisina tres veces al día en pacientes con diabetes tipo 2 insuficientemente controlados con insulina glargina con o sin metformina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of lixisenatide versus insulin glulisine on top of insulin glargine with or without metformin in type 2 diabetic patients
    Eficacia y seguridad de lixisenatida versus insulina glulisina con insulina glargina con o sin metformina en pacientes con diabetes tipo 2
    A.4.1Sponsor's protocol code numberEFC12626
    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 et 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 pointCSU Director
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 5ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 93 485 94 66
    B.5.5Fax number+34 93 489 54 66
    B.5.6E-mailbibiana.figueres@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 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 namelixisenatide
    D.3.2Product code AVE0010
    D.3.4Pharmaceutical form Solution for injection
    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 INNLixisenatide
    D.3.9.1CAS number 320367-13-3
    D.3.9.2Current sponsor codeAVE0010
    D.3.9.3Other descriptive nameLIXISENATIDE
    D.3.9.4EV Substance CodeSUB32251
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) 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 No
    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 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 namelixisenatide
    D.3.2Product code AVE0010
    D.3.4Pharmaceutical form Solution for injection
    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 INNLixisenatide
    D.3.9.1CAS number 320367-13-3
    D.3.9.2Current sponsor codeAVE0010
    D.3.9.3Other descriptive nameLIXISENATIDE
    D.3.9.4EV Substance CodeSUB32251
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(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 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) 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 No
    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 Apidra 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
    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 GLULISINE
    D.3.9.1CAS number 207748-29-6
    D.3.9.3Other descriptive nameINSULIN GLULISINE
    D.3.9.4EV Substance CodeSUB20054
    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 2 Diabetes mellitus
    Diabetes tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes
    Diabetes tipo 2
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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 lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin.
    Comparar lixisenatida versus insulina glulisina en cuanto a la reducción del nivel de HbA1c y cambio de peso corporal en la semana 26 en pacientes con diabetes tipo 2 no controlados adecuadamente con insulina glargina ± metformina.
    E.2.2Secondary objectives of the trial
    To compare the treatments/regimens on:
    ? The percentage of patients reaching the target of HbA1c <7% or ?6.5%
    ? Body weight;
    ? Self-Monitored Glucose profiles
    ? Fasting Plasma Glucose (FPG)
    ? Post-prandial plasma glucose /glucose excursions during a standardized
    meal test (subset of patients)
    ? Daily doses of insulins
    ? Safety and tolerability
    Evaluar el efecto de las 3 pautas posológicas/tratamientos de lixisenatida en:
    - El porcentaje de pacientes que han alcanzado el nivel objetivo de HbA1c menor a 7 % o menor o igual a 6,5 %
    - El peso corporal
    - Los perfiles de autocontrol de la glucosa plasmática (ACGP) de 7 puntos
    - La glucosa plasmática en ayunas (GPA)
    - La glucosa posprandial y las fluctuaciones de glucosa durante la prueba de ingesta alimentaria estándar (los pacientes que han recibido una inyección del producto en investigación [PEI] antes del desayuno)
    - Dosis diarias de insulina(s).
    - Evaluar la seguridad y tolerabilidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Patients with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1) .
    ? Patients treated with basal insulin for at least 6 months.
    ? Patients treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (ie type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20 %) and ?20 U/day for at least 2 months prior to visit 1.
    ? Patients treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that can be: metformin (?1.5g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor. The dose of OADs should be stable for at least 3 months prior to visit 1.
    ? Pacientes con diabetes mellitus tipo 2 diagnosticada al menos 1 año antes de la visita de selección (V1).
    ? Pacientes tratados con insulina basal durante al menos 6 meses
    ? Pacientes tratados durante al menos los 3 meses anteriores a la visita 1 con una pauta estable de insulina basal (es decir, tipo de insulina y hora/frecuencia de la inyección). La dosis de insulina debe ser estable (± 20 %) y ? 20 U/día durante al menos los 2 meses anteriores a la visita 1.
    ? Pacientes tratados con insulina basal sola o en combinación con 1, 2 o 3 antidiabéticos orales (ADO) que pueden ser: metformina (? 1,5 g/día o la dosis máxima tolerada), una sulfonilurea (SU) o un inhibidor de la dipeptidil-peptidasa-4 (DPP-4). La dosis de ADO debe mantenerse estable al menos durante los 3 meses anteriores a la visita 1.
    E.4Principal exclusion criteria
    ? At screening: age < legal age of majority
    ? At screening, HbA1c: < 7.5% and > 10.0% for patients treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for patients treated with basal insulin and a combination of oral anti-diabetic drugs which includes a SU and/or a DPP­4 inhibitor
    ?Women of childbearing potential with no effective contraceptive method, pregnancy or lactation
    ? Type 1 diabetes mellitus
    ?Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.
    ?Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.
    ?Previous treatment with exenatide, liraglutide or any other GLP-1 receptor agonist
    ?At screening, Body Mass Index (BMI) ?20 or >40 kg/m².
    ?Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.
    ? Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.
    ? History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
    ? At screening resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 95 mmHg
    ? Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
    ? Contraindication related to metformin (for patient receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.
    ? Patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease, if no treatment with metformin
    ? At screening, amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN)
    ? At screening ALT or AST>3ULN
    ? At screening calcitonin ?20 pg/ml (5.9 pmol/L)
    Exclusion Criteria for randomization at the end of the screening period before randomization:
    ? HbA1c <7.0% or >9.0%.
    ? 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).
    ? Amylase and/or lipase > 3 times ULN.
    ? En la selección: edad menor a la mayoría de edad legal
    ? HbA1c:
    - < 7,5 % y > 10,0 % en pacientes tratados con insulina basal sola o combinada con metformina únicamente.
    - < 7,0 % y > 10,0 % en pacientes tratados con insulina basal y una combinación de antidiabéticos orales, incluida una SU y/o un inhibidor de DPP-4.
    ? Tratamiento con hipoglucemiantes distintos a los indicados en los criterios de inclusión en los 3 meses anteriores a la selección.
    ? Tratamiento previo con insulina de acción rápida o corta que no esté relacionado con una hospitalización o una enfermedad aguda.
    ? Tratamiento previo con exenatida, liraglutida u otros agonistas del receptor de GLP-1.
    ? Anomalías analíticas en el momento de la selección, incluidos:
    - Amilasa y/o lipasa > 3 veces el límite superior del intervalo analítico normal (límite superior de la normalidad, LSN)
    - ALT o AST > 3 LSN
    - Calcitonina ? 20 pg/ml (5,9 pmol/l).
    ? Contraindicación relacionada con metformina (en los pacientes que reciben este tratamiento), insulina glargina, insulina glulisina o lixisenatida.
    ? Los pacientes con insuficiencia renal grave (aclaramiento de creatinina menor de 30 ml/min calculado por la fórmula de Cockroft y Gault) o con nefropatía terminal.
    ? Antecedentes personales o familiares directos de cáncer medular de tiroides (CMT) o enfermedades genéticas que predisponen al CMT (p. ej., síndromes de neoplasia endocrina múltiple).
    ? Antecedentes de pancreatitis idiopática, pancreatitis crónica, pancreatectomía o cirugía abdominal/gástrica.
    ? Reacción alérgica a cualquier agonista del receptor de GLP-1 o insulina glargina o insulina glulisina o metacresol.
    Criterios de exclusión de la aleatorización al final del periodo de selección:
    ? En la visita 7, HbA1c < 7,0 % o > 9,0 %.
    ? Media de la glucosa plasmática calculada mediante ACGP en ayunas a partir de las autodeterminaciones de los 7 días anteriores a la visita 8 (semana 0, D1) > 140 mg/dl (7,8 mmol/l).
    ? En la visita 7, amilasa y/o lipasa > 3 veces LSN.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in HbA1c
    - Change from baseline in body weight
    ? Variación en la HbA1c desde el periodo basal hasta la semana 26.
    ? Variación en el peso corporal desde el periodo basal hasta la semana 26
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 26
    semana 26
    E.5.2Secondary end point(s)
    - Percentage of patients reaching HbA1c <7%
    - Percentage of patients reaching HbA1c ?6.5%
    - Change in body weight from baseline
    - Percentage of patients with no weight gain.
    - Change in 7-point SMPG profiles from baseline
    - Change from baseline in FPG
    - Change from baseline in post-prandial glucose /glucose excursions during a standardized meal test (subset of patients)
    - Change from baseline in insulin glargine dose
    - Daily dose of insulin glulisine
    - Total daily dose of insulins
    - Documented (PG <60 mg/dl) symptomatic hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year)
    - Severe hypoglycemia
    ? Porcentaje de pacientes que alcanzan un nivel de HbA1c < 7 % en la semana 26.
    ? Porcentaje de pacientes que alcanzan un nivel de HbA1c ? 6,5 % en la semana 26.
    ? Variación en el peso corporal desde el periodo basal hasta la semana 26
    ? Porcentaje de pacientes sin aumento de peso.
    ? Variación en los perfiles de ACGP de 7 puntos desde el periodo basal hasta la semana 26
    ? Cambio en el nivel de glucosa plasmática en ayunas (GPA) desde el periodo basal hasta la semana 26.
    ? Cambio desde el periodo basal hasta la semana 26 en la glucosa posprandial y las fluctuaciones de glucosa durante una prueba de ingesta alimentaria estándar (pacientes que hayan recibido una inyección del PEI antes del desayuno).
    ? Variación en la dosis de insulina glargina desde el periodo basal hasta la semana 26.
    ? Dosis de insulina glulisina y dosis total de insulina en la semana 26.
    ? Dosis total de insulinas
    ? El porcentaje de pacientes que:
    - Han alcanzado el nivel objetivo de HbA1c < 7% en la semana 26 y no han experimentado hipoglucemia sintomática confirmada (GP < 60 mg/dl) durante el periodo de tratamiento de 26 semanas
    - Han alcanzado el nivel objetivo de HbA1c < 7% y no han experimentado aumento de peso en la semana 26
    - Han alcanzado el nivel objetivo de HbA1c < 7%, no han aumentado de peso en la semana 26 y no han experimentado hipoglucemia sintomática confirmada (GP < 60 mg/dl) durante el periodo de tratamiento de 26 semanas.
    ? Hipoglucemia severa
    E.5.2.1Timepoint(s) of evaluation of this end point
    - week 26

    - 26 weeks for:
    Documented (PG <60 mg/dl) symptomatic hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year)
    and
    Severe hypoglycemia
    Semana 26
    El porcentaje de pacientes que:
    - Han alcanzado el nivel objetivo de HbA1c < 7% en la semana 26 y no han experimentado hipoglucemia sintomática confirmada (GP < 60 mg/dl) durante el periodo de tratamiento de 26 semanas
    - Han alcanzado el nivel objetivo de HbA1c < 7% y no han experimentado aumento de peso en la semana 26
    - Han alcanzado el nivel objetivo de HbA1c < 7%, no han aumentado de peso en la semana 26 y no han experimentado hipoglucemia sintomática confirmada (GP < 60 mg/dl) durante el periodo de tratamiento de 26 semanas.
    ? Hipoglucemia severa
    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 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 trial3
    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 EEA116
    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
    Canada
    Chile
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Italy
    Latvia
    Lithuania
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Slovakia
    Spain
    Ukraine
    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 years1
    E.8.9.1In the Member State concerned months7
    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 months7
    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 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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 700
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 155
    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 330
    F.4.2.2In the whole clinical trial 855
    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)
    No specific plan for treatment or care after the subject has ended the participation in the trial.
    No hay un plan específico para el tratamiento o la atención después de que el sujeto haya finalizado la participación en el ensayo.
    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 Decision2013-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-03
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