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    Summary
    EudraCT Number:2018-002371-18
    Sponsor's Protocol Code Number:I8B-MC-ITSB
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-15
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio prospettico, randomizzato, in doppio cieco di confronto tra LY900014 e Humalog con un gruppo di trattamento in aperto con LY900014 postprandiale in bambini e adolescenti con diabete di 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
    uno studio per paragonare l'insulina ultrarapida sperimentale, LY900014 all'insulina lispro in bambini con diabete di 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 SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    B.1.3.4CountryUnited States
    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
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@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 INNINSULINA LISPRO
    D.3.9.1CAS number 133107-64-9
    D.3.9.2Current sponsor codeINSULIN LISPRO
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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.2.5The 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.3.2Product code [A10AB04]
    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 INNINSULINA LISPRO
    D.3.9.1CAS number 133107-64-9
    D.3.9.2Current sponsor codeHumalog
    D.3.9.4EV Substance CodeSUB08195MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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
    Diabete Mellito di tipo 1
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Diabete
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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
    Testare l'ipotesi che LY900014 non sia inferiore a Humalog nel controllo della glicemia (NIM=0.4% for HbA1c) in pazienti con età compresa tra 1 e 18 anni con T1D quando somministrato come insulina prandiale in combinazione all'insulina basale come parte di un regime di trattamento di iniezioni giornaliere multiple per 26 settimane.
    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
    -Per verificare l'ipotesi che l'insulina LY900014 somministrata come insulina postprandiale fino a 20 minuti dopo l'inizio di un pasto (LY900014 + 20) non sia inferiore a Humalog, somministrata come insulina prandiale (da 0 a 2
    minuti prima del pasto), sul controllo glicemico (NIM = 0,4% per HbA1c)

    -Per verificare l'ipotesi che LY900014 sia superiore a Humalog nel migliorare il controllo glicemico (HbA1c) quando somministrato come insulina prandiale (da 0 a 2 minuti prima del pasto)

    -Per confrontare LY900014, LY900014+20 e Humalog per quanto riguarda l'incidenza e il tasso di ipoglicemia documentata post-dose
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative 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, 28November2018
    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.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Protocol Addendum I8B-MC-ITSB(3) Studio prospettico, randomizzato, in doppio cieco di confronto tra LY900014 e Humalog con un gruppo di trattamento in aperto con LY900014 postprandiale in bambini e adolescenti con diabete di tipo 1 - PRONTO-peds, 28 novembre 2018.
    L'obiettivo principale di questo addendum (I8B-MC-ITSB [3]) è di confrontare LY900014 e Humalog, quando somministrato come insulina prandiale (da 0 a 2 minuti prima dell'inizio di un pasto), rispetto all'AUC del glucosio incrementale 0 - 2 ore dopo l'inizio dei pasti ottenuti fino a 10 giorni di utilizzo del CGM alla settimana 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] Pazienti di sesso maschile o femminile con T1D per almeno 6 mesi e diagnosticati da un endocrinologo (pediatrico o adulto) specialista del diabete, o un medico esperto nel trattamento di pazienti pediatrici con diabete di tipo 1.
    [2] pazienti con età compresa tra 1 a <18 anni di età.
    [4] pazienti trattati con uno solo dei seguenti analoghi dell'insulina ad azione rapida come parte di un regime MDI per almeno gli ultimi 90 giorni:
    a. insulina lispro U-100,
    b. insulina aspart
    c. insulina glulisina o
    d. Insulina aspart ad azione rapida (deve essere approvata per l'uso nei bambini in conformità con l'etichetta del prodotto locale)
    [5] pazienti trattati con una sola delle seguenti insuline basali per almeno gli ultimi 90 giorni:
    a. insulina glargine U-100 (QD o BID), o
    b. insulina detemir U-100 (QD o BID), o
    c. insulina degludec U-100 (QD)
    [6] Uso di una dose giornaliera totale di insulina da 0,5 a = 1,5 U / kg.
    a.TDD può essere la media dei precedenti 3 a 7 giorni
    [7] pazienti con un valore HbA1c = 6,5 e = 9,5%, secondo il laboratorio centrale.
    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] pazienti con una inconsapevolezza ipoglicemica nell'opinione dello sperimentatore o che hanno avuto più di 1 episodio di ipoglicemia grave (definita come episodio di richiesta di assistenza a causa di ipoglicemia neurologicamente invalidante, indicata da coma o convulsione e / o uso di glucosio o glucagone per via endovenosa) nei 6 mesi prima dello screening (visita 1).
    [14] pazienti che sono stati ricoverati più di una volta al pronto soccorso o in ospedale a causa di uno scarso controllo glicemico (iperglicemia o chetoacidosi diabetica) nei 6 mesi prima dello screening (visita 1).
    [15] pazienti con altri disturbi clinicamente significativi o malattie concomitanti incontrollate che, secondo il parere dello sperimentatore, precludono la partecipazione allo studio o rappresentano un rischio per la sicurezza.
    [24] pazienti che ricevono una terapia cronica (che dura più di 14 giorni consecutivi) crociata con glucocorticoidi (esclusi i preparati topici, intraoculari, intranasali e inalati) o che hanno ricevuto tale terapia negli ultimi 90 giorni.
    [25] pazienti che sono stati sottoposti a un regime di trattamento che include insulina umana regolare, protamina neutra Hagedorn (NPH), polvere per inalazione Afrezza® (insulina umana), qualsiasi insulina premiscelata o uso di insuline diluite negli ultimi 90 giorni.
    [26] pazienti che stanno ricevendo qualsiasi farmaco orale o iniettabile destinato al trattamento del diabete mellito diverso dalle insuline negli ultimi 90 giorni.
    [27] pazienti che sono stati trattati con il regime CSII per = 14 giorni negli ultimi 90 giorni.
    E.5 End points
    E.5.1Primary end point(s)
    • Difference between LY900014 and Humalog in change from baseline to Week 26 in HbA1c
    Differenza tra LY900014 e Humalog nel modificare i valori di HbA1c dal baseline alla settimana 26
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26
    settimana 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
    - cambiamento dei valori di HbA1c dal baseline alla settimana 26
    - differenza tra LY900014 e Humalog nel modificare i valori di HbA1c dal baseline alla settimana 26
    - tasso (eventi/paziente/anno) e incidenza (percentule dei pazienti con eventi) di eventi documentati di ipoglicemia post-dose in 1-2 ore dopo la dose post-prandiale dalla settimana 0 alla settimana 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
    -tasso (eventi/paziente/anno) e incidenza (percentule dei pazienti con eventi) di eventi documentati di ipoglicemia post-dose in 1-2 ore dopo la dose post-prandiale dalla settimana 0 alla settimana 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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    China
    Israel
    Japan
    Mexico
    Russian Federation
    Ukraine
    United States
    Austria
    Denmark
    France
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    Czechia
    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.
    La fine dello studio è la data dell'ultima visita o l'ultima procedura programmata mostrata nel Programma di Attività per l'ultimo paziente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years0
    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.1.1.1In 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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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.
    LY900014 non sarà messo a disposizione dei pazienti dopo la conclusione dello studio. Gli analoghi dell'insulina ad azione rapida (come Humalog e NovoLog) sono disponibili in tutti i paesi per l'uso come insulina prandiale. Il trattamento spetta al ricercatore principale e al paziente.
    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 Decision2019-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-02
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