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    Summary
    EudraCT Number:2018-002371-18
    Sponsor's Protocol Code Number:I8B-MC-ITSB
    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:2019-04-09
    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 number2018-002371-18
    A.3Full title of the trial
    A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog with an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents with Type 1 Diabetes
    PRONTO-PEDS
    Estudio prospectivo, aleatorizado y con enmascaramiento doble, en el que se compara LY900014 con Humalog, con un grupo en el que se administra LY900014 posprandial sin enmascaramiento, en niños y adolescentes con diabetes de tipo 1: PRONTO-PEDS
    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 insulin lispro in children with type 1 diabetes
    Estudio en el que se compara una insulina ultrarrápida en investigación (LY900014) con la insulina lispro en niños con diabetes de tipo 1.
    A.3.2Name or abbreviated title of the trial where available
    PRONTO-Peds
    PRONTO-Peds
    A.4.1Sponsor's protocol code numberI8B-MC-ITSB
    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 pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressIsland House, Eastgate Road, Eastgate Business Park
    B.5.3.2Town/ cityLittle Island
    B.5.3.3Post code.
    B.5.3.4CountryIreland
    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 lispro
    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.3.1Product nameHumalog®
    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 CodeSUB08195MIG
    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, tipo 1
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Diabetes
    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 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 test the hypothesis that LY900014 is noninferior to Humalog on glycemic control (NIM=0.4% for HbA1c) in patients 1 to <18 years of age with T1D when administered as prandial insulin in combination with basal insulin as part of a multiple daily injection regimen for 26 weeks
    Contrastar la hipótesis de que LY900014 no es inferior a Humalog desde el punto de vista del control glucémico (margen de no inferioridad [MNI] = 0,4 % para la HbA1c) en pacientes de entre 1 y < 18 años con DT1 cuando se administra como insulina prandial en combinación con una insulina basal, como parte de un tratamiento con múltiples inyecciones diarias durante 26 semanas.
    E.2.2Secondary objectives of the trial
    -To test the hypothesis that LY900014 administered as postprandial insulin up to 20 minutes after the start of a meal (LY900014+20) is noninferior to Humalog, administered as prandial insulin (0 to 2
    minutes prior to the meal), on glycemic control (NIM=0.4% for HbA1c)

    -To test the hypothesis that LY900014 is superior to Humalog in improving glycemic control (HbA1c) when administered as prandial insulin (0 to 2 minutes prior to the meal)

    -To compare LY900014, LY900014+20, and Humalog with respect to the incidence and rate of documented post-dose hypoglycemia
    -Contrastar la hipótesis de que LY900014 administrado como insulina posprandial hasta 20 minutos después del inicio de una comida (LY900014+20) no es inferior a Humalog, cuando se administra como insulina prandial entre 0 y 2 minutos antes de las comidas, desde el punto de vista del control glucémico (MNI = 0,4 % para la HbA1c).
    -Contrastar la hipótesis de que LY900014 es superior a Humalog desde el punto de vista de la mejoría del control glucémico (HbA1c), cuando se administra como insulina prandial (entre 0 y 2 minutos antes de las comidas).
    -Comparar LY900014, LY900014+20 y Humalog con respecto a la incidencia y la tasa de hipoglucemia documentada tras la administración de la dosis.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol Addendum I8B-MC-ITSB(3) A Prospective, Randomized, Double-Blind Comparison of
    LY900014 to Humalog with an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents with Type 1 Diabetes, PRONTO-Peds, 28.November2018

    The primary objective of this addendum (I8B-MC-ITSB [3]) is to compare LY900014 and
    Humalog, when administered as prandial insulin (0 to 2 minutes prior to the start of a meal), with
    respect to the incremental glucose AUC 0-2hours after the start of meals obtained from up to
    10 days of CGM use at Week 26.
    Adenda al protocolo I8B-MC-ITSB (3): Estudio prospectivo, aleatorizado y con enmascaramiento doble, en el que se compara LY900014 con Humalog, con un grupo en el que se administra LY900014 posprandial sin enmascaramiento, en niños y adolescentes con diabetes de tipo 1: PRONTO-PEDS (28 de noviembre de 2018).
    El objetivo principal de esta adenda (I8B-MC-ITSB [3]) es comparar LY900014 y Humalog cuando se administra como insulina prandial (entre 0 y 2 minutos antes del inicio de una comida), desde el punto de vista del aumento gradual del área bajo la curva (ABC) de glucosa entre 0 y 2 horas después del inicio de las comidas, determinado mediante la medición continua de la glucosa (MCG) durante un período de hasta 10 días en la semana 26.
    E.3Principal inclusion criteria
    [1] Male or female patients with T1D for at least 6 months and diagnosed by an endocrinologist (pediatric or adult), diabetes specialist, or a physician with expertise in treating pediatric patients with Type 1 diabetes.
    [2] Are at least 1 to <18 years of age.
    [4] Have been treated with only one of the following rapid-acting insulin analogs as part of an MDI regimen for at least the last 90 days:
    a. insulin lispro U-100, or
    b. insulin aspart
    c. insulin glulisine or
    d. Fast acting insulin aspart (must be approved for use in children in accordance with the local product label)
    [5] Have been treated with only one of the following basal insulins for at least the last 90 days:
    a. insulin glargine U-100 (QD or BID), or
    b. insulin detemir U-100 (QD or BID), or
    c. insulin degludec U-100 (QD)
    [6] Use a total daily dose of insulin 0.5 to ≤1.5 U/kg.
    a.TDD can be the average of previous 3 to 7 days
    [7] Have an HbA1c value ≥6.5 and ≤9.5%, according to the central laboratory.
    [1] Pacientes de ambos sexos que presenten DT1 al menos desde hace 6 meses y a los que hayan diagnosticado un endocrino (que trate niños o adultos), un especialista en diabetes o un médico experto en el tratamiento de niños con diabetes de tipo 1.
    [2] Tener entre 1 y < 18 años.
    [4] Haber recibido solo uno de los siguientes análogos de insulina de acción rápida como parte de un tratamiento con múltiples inyecciones diarias al menos durante los últimos 90 días:
    a. insulina lispro U-100, o
    b. insulina aspart
    c. insulina glulisina, o
    d. insulina aspart de acción rápida (cuyo uso en niños debe estar aprobado de conformidad con la ficha técnica local).
    [5] Haber recibido solo una de las siguientes insulinas basales al menos durante los últimos 90 días:
    a. insulina glargina U-100 (1 v/d o 2 v/d), o
    b. insulina detemir U-100 (1 v/d o 2 v/d), o
    c. insulina degludec U-100 (1 v/d)
    [6] Tomar una dosis diaria total de insulina de entre 0,5 y ≤1,5 U/kg.
    a. La dosis total de insulina puede ser la media de los 3 a 7 días previos.
    [7] Presentar una concentración de HbA1c ≥6,5 y ≤9,5 %, de acuerdo con los resultados obtenidos en un laboratorio central.
    E.4Principal exclusion criteria
    [13] Have current hypoglycemic unawareness in the investigator’s opinion or have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia, indicated by coma or convulsion and/or use of intravenous glucose or glucagon) within 6 months prior to screening (Visit 1).
    [14] Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening (Visit 1).
    [15] Have any other clinically significant disorder or uncontrolled concomitant disease that, in the investigator's opinion, would preclude participation in the trial or pose a safety risk.
    [24] Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, and inhaled preparations) or have received such therapy within the last 90 days.
    [25] Have been on a treatment regimen that includes regular human insulin, neutral protamine Hagedorn (NPH), Afrezza® (insulin human) inhalation powder, any premixed insulins or use of diluted insulins within the last 90 days.
    [26] Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins within the last 90 days.
    [27] Have been treated by CSII regimen for ≥14 days within the last 90 days.
    [13] Presentar en la actualidad, en opinión del investigador, insensibilidad a la hipoglucemia o haber sufrido 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; esto es, aparición de coma o convulsiones o que se precise administrar glucosa o glucagón por vía intravenosa) en el transcurso de los 6 meses anteriores a la selección (visita 1).
    [14] Haber acudido a urgencias o haber sido hospitalizado más de una vez por haber presentado un mal control glucémico (hiperglucemia o cetoacidosis diabética), en el transcurso de los 6 meses anteriores a la selección (visita 1).
    [15] Presentar cualquier otro trastorno de trascendencia clínica o enfermedad concomitante sin controlar que, en opinión del investigador, impediría la participación en el estudio o constituiría un riesgo para la seguridad del paciente.
    [24] Recibir tratamiento sistémico y prolongado (durante más de 14 días consecutivos) con glucocorticoides (a excepción de las preparaciones tópicas, intranasales, intraoculares e inhaladas), o haber recibido dicho tratamiento en el transcurso de los últimos 90 días.
    [25] Haber recibido un tratamiento que incluya la insulina humana ordinaria, la insulina isófana (NPH), Afrezza® (insulina humana en polvo para inhalación), cualquier combinación de insulinas premezcladas o insulinas diluidas en el transcurso de los últimos 90 días.
    [26] Haber recibido cualquier medicamento oral o inyectable para tratar la diabetes mellitus (excepto insulinas) en el transcurso de los últimos 90 días.
    [27] Haber recibido infusiones subcutáneas continuas de insulina (ISCI) durante ≥14 días en el transcurso de los últimos 90 días.
    E.5 End points
    E.5.1Primary end point(s)
    • Difference between LY900014 and Humalog in change from baseline to Week 26 in HbA1c
    Diferencia entre LY900014 y Humalog en la variación de la concentración de HbA1c desde el período inicial 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)
    • Change from baseline to Week 26 in HbA1c
    • Difference between LY900014 and Humalog in change from baseline to Week 26 in HbA1c
    • Rate (events/patient/year) and incidence (percentage of patients with events) of documented post-dose hypoglycemic events within 1 and 2 hours after the prandial dose from Weeks 0 through Week 26
    • Variación de la concentración de HbA1c desde el período inicial hasta la semana 26.
    • Diferencia entre LY900014 y Humalog en la variación de la concentración de HbA1c desde el período inicial hasta la semana 26.
    • Tasa (episodios/paciente/año) e incidencia (porcentaje de pacientes con episodios) de episodios documentados de hipoglucemia en el transcurso de la primera y de las dos primeras horas posteriores a la dosis prandial, desde la semana 0 hasta la semana 26.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Rate (events/patient/year) and incidence (percentage of patients with events) of documented post-dose hypoglycemic events within 1 and 2 hours after the prandial dose from Weeks 0 through 26
    • Tasa (episodios/paciente/año) e incidencia (porcentaje de pacientes con episodios) de episodios documentados de hipoglucemia en el transcurso de la primera y de las dos primeras horas posteriores a la dosis prandial, desde la semana 0 hasta la semana 26.
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Austria
    Brazil
    China
    Czech Republic
    Denmark
    France
    Germany
    Israel
    Italy
    Japan
    Mexico
    Poland
    Russian Federation
    Spain
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    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.
    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 months8
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days17
    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: 708
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 318
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 384
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state708
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 708
    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)
    LY900014 will not be made available to patients after conclusion of the study. Rapid-acting insulin analogs (such as Humalog and NovoLog) are available in all countries for use as prandial insulin. Treatment is up to the principal investigator and patient.
    Los pacientes no tendrán acceso a LY900014 tras la conclusión del estudio. Los análogos de insulina de acción rápida (como Humalog y NovoLog) están disponibles en todos los países como insulina prandial. El investigador principal y el paciente determinarán conjuntamente el tratamiento que ha de administrarse.
    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 Decision2019-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-02
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