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    Summary
    EudraCT Number:2015-005358-36
    Sponsor's Protocol Code Number:I8B-MC-ITRO
    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:2019-04-11
    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 number2015-005358-36
    A.3Full title of the trial
    I8B MC ITRO
    A Prospective, Randomized, Double Blind Comparison of LY900014 to Humalog in Adults with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
    Comparación prospectiva, aleatorizada y doble ciego de LY900014 con Humalog en adultos con diabetes de tipo 1 utilizando una infusión subcutánea continua de insulina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare an investigational ultra-rapid insulin LY900014 with Humalog given by insulin pump in people with type 1 diabetes.
    Estudio en el que se compara una insulina ultrarrápida en investigación (LY900014) con Humalog administradas mediante bomba de insulina a personas con diabetes de tipo 1.
    A.3.2Name or abbreviated title of the trial where available
    PRONTO Pump 2
    PRONTO Pump 2
    A.4.1Sponsor's protocol code numberI8B-MC-ITRO
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly Cork Ltd
    B.5.2Functional name of contact pointGennaro De Crescenzo
    B.5.3 Address:
    B.5.3.1Street AddressIsland House, 11 Eastgate Road, Eastgate Business Park
    B.5.3.2Town/ cityLittle Island, Co. Cork
    B.5.3.3Post codeT45 KD39
    B.5.3.4CountryIreland
    B.5.4Telephone number003491836 2958
    B.5.6E-mailensayosclinicos@lilly.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 nameultra-rapid formulation of insulin
    D.3.2Product code LY900014
    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 LISPRO
    D.3.9.1CAS number 133107-64-9
    D.3.9.4EV Substance CodeSUB08198MIG
    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.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 Humalog
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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 LISPRO
    D.3.9.1CAS number 133107-64-9
    D.3.9.4EV Substance CodeSUB08198MIG
    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
    Diabetes Mellitus, Type 1
    Diabetes mellitus de tipo 1
    E.1.1.1Medical condition in easily understood language
    Type 1 Diabetes
    Diabetes de tipo 1.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term 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 test the hypothesis that LY900014 is noninferior to Humalog on glycemic control ([NIM = 0.4% for HbA1c) in patients with T1D using CSII for 16 weeks
    Comprobar la hipótesis de que LY900014 no es inferior a Humalog en el control de la glucemia ([margen de ausencia de inferioridad (MAI) = 0,4 % para la HbA1c) en pacientes con DT1 que utilizan ISCI durante 16 semanas.
    E.2.2Secondary objectives of the trial
    1-To test the hypothesis that LY900014 is superior to Humalog in controlling 1 hour postprandial glucose (PPG) excursions
    2-To test the hypothesis that LY900014 is superior to Humalog in controlling 2 hour PPG excursions
    3-To test the hypothesis that LY900014 is superior to Humalog on improving glycemic control (HbA1c)
    4-To compare LY900014 and Humalog with respect to the rate of severe hypoglycemic events
    5-To compare LY900014 and Humalog with respect to the rate and incidence of documented postmeal hypoglycemia
    6-To compare LY900014 and Humalog with respect to the rate and incidence of documented hypoglycaemia
    7-To compare LY900014 and Humalog with respect to 1,5 AG
    8-To compare LY900014 and Humalog with respect to 10 point SMBG profiles
    9-To compare LY900014 and Humalog with respect to total, basal, and bolus insulin dose
    10-To compare LY900014 and Humalog with respect to the proportion of patients achieving HbA1c targets
    1 Comprobar la hipótesis de q LY900014 es superior a Humalog en control de las oscilaciones de la glucosa posprandial (GPP) durante 1 h
    2 Comprobar la hipótesis de q LY900014 es superior a Humalog en control de las oscilaciones de la GPP durante 2 h
    3 Comprobar la hipótesis de q LY900014 es superior a Humalog en mejora del control de la glucemia (HbA1c)
    4 Comparar LY900014 y Humalog cn respecto a la tasa de episodios de hipoglucemia grave
    5 Comparar LY900014 y Humalog cn respecto a la tasa e incidencia de hipoglucemia posprandial documentada
    6 Comparar LY900014 y Humalog cn respecto a la tasa e incidencia de hipoglucemia documentada
    7 Comparar LY900014 y Humalog cn respecto a la concentración de 1,5-AG
    8 Comparar LY900014 y Humalog con respecto a los perfiles de ACG de 10 puntos
    9 Comparar LY900014 y Humalog con respecto a la dosis de insulina total, basal y en bolo
    10 Comparar LY900014 y Humalog con respecto a la proporción de pacientes que consigan los objetivos de HbA1c
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Men or women diagnosed (clinically) with T1D for at least 1 year prior to screening, and continuously using insulin for at least 1 year
    •Are at least 18 years of age
    •Have been using CSII therapy for a minimum of 6 months prior to screening. Interruption of CSII is allowed during the 6 months prior to screening for up to a total of 14 days, such as during a hospitalization, a pump malfunction, or a “pump holiday”
    •Must be using a MiniMed 530G or 630G (US), 640G (EU), insulin pump for at least the last 90 days and willing to stay on the same pump throughout the study
    •Are willing to maintain their current bolus delivery speed (standard or quick) for the duration of the study
    •Have HbA1c values of ≥6.5 and ≤9.0%, as determined by the central laboratory at screening (Visit 1)
    •Have a body mass index (BMI) of ≤35.0 kg/m2 at screening (Visit 1)
    • Personas de ambos sexos con diagnóstico clínico de DT1 al menos desde 1 año antes de la selección que tomen insulina de forma continua al menos desde hace 1 año.
    • Tener al menos 18 años de edad.
    • Haber recibido tratamiento con ISCI al menos durante los 6 meses anteriores a la selección. Durante los 6 meses anteriores a la selección se permite que el tratamiento con ISCI se haya interrumpido durante 14 días en total, por ejemplo, por hospitalizaciones, un mal funcionamiento de la bomba o para "descansar de la bomba".
    • Haber utilizado las bombas de insulina MiniMed 530G o 630G (EE. UU.) o 640G (UE) al menos durante los últimos 90 días y estar dispuesto a continuar usando la misma bomba a lo largo del estudio.
    • Estar dispuesto a mantener la velocidad de administración actual en embolada (normal o rápida) durante el estudio.
    • Presentar en la selección (visita 1) una concentración de HbA1c ≥6,5 % y ≤9,0 % de acuerdo con los resultados obtenidos en el laboratorio central.
    • Presentar un índice de masa corporal (IMC) ≤35,0 kg/m2 en la selección (visita 1).
    E.4Principal exclusion criteria
    -Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the patient from following and completing the protocol
    -Have hypoglycemia unawareness as judged by the investigator
    -Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening
    -Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or DKA) within 6 months prior to screening
    -Have cardiovascular disease, within the last 6 months prior to screening, defined as stroke, decompensated heart failure New York Heart Association class III or IV (CCNYHA 1994), myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary arterial bypass graft

    Renal:
    a. History of renal transplantation
    b. Currently receiving renal dialysis
    c. Serum creatinine >2.0 mg/dL (177 µmol/L) at screening, or
    d. An estimated glomerular filtration rate of <30 mL/min/1.73 m2.

    -Hepatic: have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis, or cirrhosis), or elevated liver enzyme measurements as indicated below at screening
    a. Total bilirubin level (TBL) ≥2X the upper limit of normal (ULN) (with the exception of Gilberts Disease) as defined by the central laboratory,
    Or
    b. Alanine aminotransferase (ALT) ≥3X ULN as defined by the central laboratory,
    Or
    c. Aspartate aminotransferase (AST) ≥3X ULN as defined by the central laboratory

    -Hematologic: have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hemoglobinopathy, anemia that is clinically significant based on investigator judgement, or any other traits of known to interfere with measurement of HbA1c
    -Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations; includes those with gastric bypass) in the opinion of investigator
    -Have significant lipohypertrophy, lipoatrophy, or scars within the SC tissue in areas of infusion, in the opinion of the investigator
    -Have a history of abscess at an infusion site within the last 90 days prior to screening
    -Have vision loss or hearing loss that does not allow recognition of pump screens, alerts and alarms
    -Padecer cualquier otra enfermedad (incluidas toxicomanías, alcoholismo o trastornos psiquiátricos, entre los que se incluyen los trastornos alimenticios) que impida que el paciente siga y complete el protocolo.
    -Presentar hipoglucemia asintomática según el criterio del investigador.
    -Haber experimentado más de 1 episodio de hipoglucemia grave (cualquier episodio en el que el paciente precise asistencia de otra persona debido a la presencia de hipoglucemia neurológicamente incapacitante) en el transcurso de los 6 meses anteriores a la selección.
    -Haber acudido a urgencias o haber sido hospitalizado más de una vez por presentar un mal control glucémico (hiperglucemia o cetoacidosis diabética) en el transcurso de los 6 meses anteriores a la selección.
    -Haber experimentado una enfermedad cardiovascular en el transcurso de los 6 meses anteriores a la selección (accidente cerebrovascular, insuficiencia cardiaca descompensada de clase III o IV [de acuerdo con la New York Heart Association (1994)], infarto de miocardio, angina de pecho inestable, angioplastia coronaria transluminal percutánea o revascularización coronaria).
    Renal:
    a. Antecedentes de trasplante renal.
    b. Recibir en la actualidad diálisis renal.
    c. Concentración sérica de creatinina >2,0 mg/dl (177 µmol/l) durante la selección, o
    d. Filtración glomerular estimada <30 ml/min/1,73 m2.

    -Hepática: presentar durante la selección signos o síntomas clínicos claros de hepatopatía (por ejemplo, hepatitis aguda o crónica, o cirrosis) o elevación de las enzimas hepáticas, según se indica a continuación:
    a. Concentración total de bilirrubina (CTB) ≥2 veces el límite superior de la normalidad (LSN) (salvo si el paciente tiene la enfermedad de Gilbert) de acuerdo con una prueba realizada en el laboratorio central.
    O
    b. Concentración de alanina aminotransferasa (ALT) ≥3 veces el LSN de acuerdo con una prueba realizada en el laboratorio central.
    O
    c. Concentración de aspartato aminotransferasa (AST) ≥3 veces el LSN de acuerdo con una prueba realizada en el laboratorio central.

    -Hematológica: Haber recibido una transfusión de sangre o haber experimentado una pérdida importante de sangre en el transcurso de los 90 días anteriores a la selección, o presentar hemoglobinopatía, anemia que, de acuerdo con la opinión del investigador, tenga trascendencia clínica, o cualquier otra enfermedad que interfiera con la medición de la concentración de HbA1c.
    -Enfermedad gastrointestinal clínicamente importante (por ejemplo, gastroparesia clínicamente activa, asociada con fluctuaciones marcadas de los valores de glucosa [incluidos los pacientes con derivación gástrica]) de acuerdo con el criterio del investigador.
    -Lipohipertrofia, lipoatrofia o cicatrices importantes en el tejido subcutáneo de los lugares de infusión de acuerdo con el criterio del investigador.
    -Antecedentes de abscesos en un lugar de infusión en los 90 días anteriores a la selección.
    -Pérdida de visión o de sordera parcial que no permitan reconocer las pantallas, las alertas y las alarmas de la bomba.
    E.5 End points
    E.5.1Primary end point(s)
    Difference between LY900014 and Humalog in change from baseline to Week 16 in HbA1c
    Diferencia entre LY900014 y Humalog en la variación de la HbA1c entre el momento basal y la semana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    1.Difference between LY900014 and Humalog in the 1-hour PPG excursion (serum glucose measured 1 hour after the start of the meal minus fasting serum glucose) from a MMTT at Week 16
    2.Difference between LY900014 and Humalog in the 2-hour PPG excursion (serum glucose measured 2 hour after the start of the meal minus fasting serum glucose) from a MMTT at Week 16
    3.Difference between LY900014 and Humalog in change from baseline to Week 16 in HbA1c
    4.Rate (events/ patient/100 years) of severe hypoglycemic events from baseline through Week 16
    5.Rate (events/patient/year) and incidence (percent of patients with at least 1 event) of documented postmeal hypoglycemia within 1 and 2 hours after the start of the meal from baseline through Week 16
    6.Rate (events/patient/year) and incidence (percentage of patients with events) of documented hypoglycemic events from baseline through Week 16
    7.Change from baseline 1,5-AG values at Week 16
    8.Change from baseline 10-point SMBG values at Week 16
    9.Change from baseline in bolus/total insulin dose ratio at Week 16
    1. Diferencia entre LY900014 y Humalog en la oscilación de la GPP durante 1 hora (glucosa en suero medida 1 hora después del inicio de la comida menos la glucosa en suero en ayunas) en una MMTT (prueba de tolerancia de una comida mixta) en la semana 16
    2. Diferencia entre LY900014 y Humalog en la oscilación de la GPP durante 2 horas (glucosa en suero medida 2 horas después del inicio de la comida menos la glucosa en suero en ayunas) en una MMTT en la semana 16
    3. Diferencia entre LY900014 y Humalog en la variación de la HbA1c entre el momento basal y la semana 16
    4. Tasa (episodios/100 años/paciente) de episodios de hipoglucemia grave entre el momento basal y la semana 16
    5. Tasa (episodios/año/paciente) e incidencia (porcentaje de pacientes con al menos 1 episodio) de hipoglucemia posprandial documentada 1 y 2 horas después del inicio de la comida desde el momento basal hasta la semana 16
    6. Tasa (episodios/año/paciente) e incidencia (porcentaje de pacientes con episodios) de episodios de hipoglucemia documentados desde el momento basal hasta la semana 16
    7. Variación de los valores de 1,5-AG entre el momento basal y la semana 16
    8. Variación de los valores de ACG de 10 puntos entre el momento basal y la semana 16
    9. Variación del cociente de dosis de insulina en bolo/total entre el momento basal y la semana 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16 for all secondary endpoints
    Semana 16 para todos los criterios de valoración secundarios.
    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 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 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 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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Australia
    Austria
    Canada
    France
    Germany
    Hungary
    Israel
    Italy
    Spain
    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 - End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities for the last patient
    UVUPP (última visita o último procedimiento programado) : El final del ensayo es la fecha de la última visita o del último procedimiento programado para el último paciente del estudio según se detalla en el calendario de actividades.
    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 months9
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days6
    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: 380
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 420
    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)
    Patients will resume their previous diabetes therapy after completing
    the trial.
    Tras completar el ensayo, los pacientes reanudarán el tratamiento para la diabetes que recibieran antes de este.
    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 Decision2019-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-06
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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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