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    Summary
    EudraCT Number:2015-005358-36
    Sponsor's Protocol Code Number:I8B-MC-ITRO
    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:2021-02-11
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-005358-36
    A.3Full title of the trial
    A Prospective, Randomized, Double Blind Comparison of LY900014 to Humalog in Adults with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
    Studio prospettico, randomizzato, in doppio cieco che confronta LY900014 con Humalog in pazienti adulti con diabete di tipo I che utilizzano l’infusione continua sottocutanea di insulina: PRONTO-Pump-2
    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.
    Studio per paragonare l' efficacia dell'insulina ultra-rapida LY900014 a Humalog nei pazienti con diabete di tipo 1 che usano infusione sottocutanea continua di insulina
    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 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 nameFormulazione di insulina ultra-rapida
    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 INNFormulazione ultra-rapida di insulina
    D.3.9.1CAS number 133107-64-9
    D.3.9.2Current sponsor codeLY900014
    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.2.1.1.2Name 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.3.2Product code [Humalog]
    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 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.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
    Type 1 Diabetes
    Diabete di 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
    L’obiettivo del presente studio è dimostrare che una formulazione di insulina lispro ultrarapida, LY900014 non è inferiore a Humalog per quanto riguarda il controllo glicemico misurato come variazione dell’HbA1c dal basale alla settimana 16 in pazienti con DT1 che utilizzano la CSII con boli somministrati in doppio cieco mediante microinfusore appena prima di ogni pasto.
    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
    Verificare l’ipotesi secondo cui LY900014 è superiore a Humalog nel controllo delle escursioni del glucosio plasmatico postprandiale (PPG) a 1 ora
    Verificare l’ipotesi secondo cui LY900014 è superiore a Humalog nel controllare le escursioni del PPG a 2 ore
    Verificare l’ipotesi secondo cui LY900014 è superiore a Humalog nel migliorare il controllo glicemico (HbA1c)
    Confrontare LY900014 e Humalog in merito al tasso di eventi ipoglicemici di grado severo
    Confrontare LY900014 e Humalog in termini di tasso e incidenza di eventi ipoglicemici postprandiali documentati
    Confrontare LY900014 e Humalog in termini di tasso e incidenza di eventi ipoglicemici documentati
    Confrontare LY900014 e Humalog in termini di 1,5-AG
    Confrontare LY900014 e Humalog in termini di profili di SMBG a 10 punti
    Confrontare LY900014 e Humalog in termini di dose di insulina totale, basale e in bolo
    Confrontare LY900014 e Humalog in termini di percentuale di pazienti che raggiungono gli obiettivi per l’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.
    •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)
    - Pazienti uomini o donne con diagnosi clinica di diabete mellito di tipo 1 da almeno un anno (precedente allo screening), che stiano utilizzando insulina continuamente da almeno un anno
    -Pazienti con almeno 18 anni di età
    -Utilizzo di terapia CSII per un minimo di sei mesi precedenti allo screening. L'interruzione dell'infusione continua di insulina è permessa durante i sei mesi precedenti allo screening, per un totale di 14 giorni.
    -Utilizzo di microinfusore Minimed 640G negli ultimi 90 giorni e disponibilità ad utilizzare lo stesso microinfusore per tutta la durata dello studio.
    -Disponibilità a mantenere la stessa velocità di somministrazione del bolo (standard o veloce) per tutta la durata dello studio.
    - Avere valori di HbA1c di=6.5 e =9.0%, da stabilire allo screening (visita 1) tramite laboratorio centralizzato
    -Avere un indice di massa corporea (BMI) di =35 kg/m2 allo screening (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:
    History of renal transplantation or currently receiving renal dialysis

    -Hepatic: have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis, or cirrhosis)

    -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
    -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 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
    -Condizioni (inclusi abuso di alcol o sostanze stupefacenti, disturbi dell'alimentazione o disturbi psichiatrici) che possano impedire al paziente di seguire o completare il protocollo
    - Pazienti con inconsapevolezza ipoglicemica valutata sallo sperimentatore
    - Pazienti che abbiano avuto più di un episodio di severa ipoglicemia (abbiano avuto bisogno di assistenza a causa di ipoglicemia debilitante a livello neurologico) entro i sei mesi precedenti allo screening
    - Pazienti che abbiano ricevuto un trattamento di emergenza a causa di grave ipoglicemia o di insufficiente controllo della glicemia nei 6 mesi precedenti allo screening.
    -Pazienti con disturbi cardiovascolari nei sei mesi precedenti allo screening,come ictus, insufficienza cardiaca, angina, bypass coronarico o attacco cardiaco.
    -Anamnesi di trapianto renale o attualmente in dialisi
    -Malattia epatica come l’epatite o la cirrosi
    -Il paziente ha ricevuto una trasfusione di sangue o ha avuto una perdita di sangue importante negli ultimi 90 giorni, oppure ha determinati tipi di disturbi ematici (emoglobinopatia, anemia clinicamente significativa)
    - Gastroparesi o bypass gastrico
    -Il paziente ha avuto delle infezioni nel sito di infusione negli ultimi 90 giorni.
    -Ha una perdita della vista o dell’udito che impedisce di riconoscere gli schermi e i segnali acustici del microinfusore.
    E.5 End points
    E.5.1Primary end point(s)
    Difference between LY900014 and Humalog in change from baseline to Week 16 in HbA1c
    Differenza tra LY900014 e Humalog per quanto riguarda la variazione dell’HbA1c dal basale alla settimana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Settimana 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

    Differenza tra LY900014 e Humalog nell’escursione del PPG a 1 ora (livelli di glucosio nel siero misurati 1 ora dopo l’inizio del pasto meno i livelli di glucosio nel siero a digiuno) da un MMTT alla
    settimana 16
    Differenza tra LY900014 e Humalog nell’escursione del PPG a 2 ore (livelli di glucosio nel siero misurati 2 ore dopo l’inizio del pasto meno i livelli di glucosio nel siero a digiuno) da un MMTT alla
    settimana 16
    Differenza tra LY900014 e Humalog per quanto riguarda la variazione dell’HbA1c dal basale alla settimana 16
    Tassi (eventi/paziente/100 anni) di eventi ipoglicemici di grado severo dal basale alla settimana 16
    Tasso (eventi/paziente/anno) e incidenza (percentuale di pazienti con almeno un evento) di eventi ipoglicemici postprandiali documentati a 1 e 2 ore dall’inizio del pasto dal basale alla settimana 16
    Tasso (eventi/paziente/anno) e incidenza (percentuale di pazienti con eventi) di eventi ipoglicemici sintomatici documentati dal basale alla settimana 16
    Variazione dei valori di 1,5-AG dal basale alla settimana 16
    Variazione dei valori di SMBG a 10 punti dal basale alla settimana 16
    Variazione del rapporto dose di insulina in bolo/totale dal basale alla settimana 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16 for all secondary endpoints
    Settimana 16 per tutti gli endpoint
    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 concerned5
    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 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
    Australia
    Canada
    Israel
    United States
    Austria
    France
    Germany
    Hungary
    Italy
    Spain
    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
    Ultima visita ultimo soggetto - La data di fine studio è definita come la data dell'ultima visita o l'ultima procedura schedulata come da Schedule of Activities 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 months9
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years0
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    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.
    I pazienti riprenderanno la precedente terapia per il diabete a seguito completamento dello studio
    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 Decision2019-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
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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
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