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    Summary
    EudraCT Number:2015-002084-42
    Sponsor's Protocol Code Number:EFC13957
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-03-11
    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 number2015-002084-42
    A.3Full title of the trial
    6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents age 6 - 17 Years with Type 1 Diabetes Mellitus with a 6-month Safety Extension Period
    “Studio multicentrico, randomizzato, in aperto, a 2 bracci paralleli, della durata di 6 mesi per confrontare l'efficacia e la sicurezza di una nuova formulazione di insulina glargine e Lantus® somministrati per iniezione una volta al giorno a bambini e adolescenti di età compresa fra 6 e 17 anni con diabete mellito di tipo 1, con un periodo di estensione di sicurezza di 6 mesi”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the Safety and Efficacy of HOE901-U300 with Lantus in Children and Adolescents with Type 1 Diabetes Mellitus
    Confronto della Sicurezza ed Efficacia di HOE901 – U300 verso Lantus in bambini e adolescenti affetti da diabete mellito di tipo 1.
    A.3.2Name or abbreviated title of the trial where available
    EDITION JUNIOR
    A.4.1Sponsor's protocol code numberEFC13957
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorsanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportsanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.P.A.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressVIALE BODIO, 37/B
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800226343
    B.5.5Fax number00390239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Toujeo
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameInsulin glargine
    D.3.2Product code HOE901 - U300
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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 GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeHOE901 - U300
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeHOE901
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 diabetes mellitus
    Diabete mellito di tipo 1
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes mellitus
    Diabete mellito di tipo 1
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 compare the efficacy of HOE901-U300 to Lantus in terms of glycated hemoglobin (HbA1c)
    Confrontare l'efficacia di insulina glargine (HOE901-U300) a Lantus, in termini di variazioni dell'emoglobina glicata (HbA1c)
    E.2.2Secondary objectives of the trial
    -To compare HOE901-U300 and Lantus in terms of:
    -Percentage of patients reaching target HbA1c and fasting plasma glucose (FPG).
    -To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.
    Confrontare HOE901-U300 e Lantus in termini di:

    • Percentuale di pazienti che raggiungono il target di HbA1c e glicemia plasmatica a digiuno (FPG)
    • Verifica della sicurezza di HOE901-U300 incluse analisi degli eventi ipoglicemici, degli eventi iperglicemici con chetosi e sviluppo di anticorpi anti-insulina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Children and adolescents with type 1 diabetes mellitus (T1DM) for at least 1 year confirmed by typical symptoms at diagnosis and/or by antibody testing (presence of anti-GAD [glutamic acid decarboxylase] or anti-IA2 [islet antigen 2/tyrosine phosphatase] or anti-islet cell antibodies) and/or clinical features (eg, history of ketoacidosis).
    -Signed written informed consent obtained from parent(s)/legal guardian and written or oral assent obtained from patient.
    • Bambini e adolescenti con T1DM da almeno 1 anno, confermato mediante sintomi tipici alla diagnosi e/o mediante test anticorpali anti-GAD [acido glutammico decarbossilasi] o anti-IA2 [antigene insulinico 2/ tirosina fosfatasi] o anticorpi anti-cellule insulari e/o caratteristiche cliniche (ad es. storia di chetoacidosi);
    • Consenso informato scritto firmato dal genitore/dai genitori/dal tutore legale e assenso scritto del paziente
    E.4Principal exclusion criteria
    -Age <6 years and ≥18 years.
    -Less than 1 year on insulin treatment prior to screening visit.
    -Less than 6 months on basal plus mealtime insulin and self-monitoring of blood glucose prior to screening visit.
    -Patients using premix insulins in the last 3 months before screening visit or patients using human regular insulin as mealtime insulin in the last 3 months before screening visit.
    -Use of an insulin pump in the last 6 months before screening visit or plans to switch to pump within the next 6 months after screening visit.
    -No willingness to inject insulin glargine (Lantus or HOE901 [U300]) once daily.
    -HbA1c <7.5% or >10% at screening.
    -Initiation of any glucose-lowering medications in the last 3 months before screening visit.
    -Hospitalization or care in the emergency ward for diabetic ketoacidosis or history of severe hypoglycemia (as defined by need for glucagon or IV glucose) and accompanied by seizure and/or unconsciousness and/or coma in the last 3 months prior to screening visit.
    -Postmenarchal girls not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy. Abstinence from sexual intercourse will be considered as an acceptable form of birth control.
    -Pregnant or breast-feeding adolescents, or adolescents who intend to become pregnant during the study period, or who are at risk of getting pregnant due to any psychosocial reason during the study period.
    • Età <6 anni e ≥18 anni;
    • Meno di 1 anno di terapia insulinica prima della visita di screening;
    • Meno di 6 mesi di insulina basale più prandiale e automonitoraggio della glicemia prima della visita di screening;
    • Pazienti che hanno utilizzato insuline premiscelate nei 3 mesi precedenti la visita di screening o pazienti che hanno usato insulina umana regolare come insulina prandiale nei 3 mesi precedenti la visita di screening;
    • Uso di pompa insulinica nei 6 mesi precedenti la visita di screening o intenzione di passare ad una pompa entro 6 mesi dalla visita di screening;
    • Mancata volontà di praticarsi/farsi praticare le iniezioni di insulina glargine (Lantus o HOE901-U300) una volta al giorno;
    • HbA1c <7.5% o >10% allo screening;
    • Inizio di terapia antiglicemica nei 3 mesi precedenti la visita di screening;
    • Ricovero o trattamento in pronto soccorso a causa di chetoacidosi diabetica o anamnesi di ipoglicemia grave (definita dalla necessità di assunzione di glucagone o di somministrazione in vena di glucosio), accompagnata da crisi e/o incoscienza e/o coma nei 3 mesi precedenti la visita di screening;
    • Ragazze post-menarca non protette da un metodo/da metodi di controllo delle nascite altamente efficace/efficaci che rifiutano o non sono in grado di sottoporsi a test di gravidanza. L'astinenza da rapporti sessuali sarà considerata una forma accettabile di controllo delle nascite;
    • Adolescenti gravide o che allattano o che prevedono una gravidanza durante il periodo di studio o che sono a rischio di gravidanza a causa di motivi psicosociali durante il periodo dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c
    Variazione dal basale dell’ HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline; Week 26
    Basale, settimana 26
    E.5.2Secondary end point(s)
    1- Percentage of patients with HbA1c values of <7.5% without any episode of severe and/or documented (SMPG <54 mg/dL; 3.0 mmol/L) symptomatic hypoglycemia during the last 3 months of the main 6-month on-treatment period
    2- Change from baseline in FPG
    3- Percentage of patients with FPG of ≤130 mg/dL (7.2 mmol/L) without any episode of severe and/or documented (SMPG ≤54 mg/dL; 3.0 mmol/L) symptomatic hypoglycemia during the last 3 months of the main 6-month
    4- Change from baseline in 24-hour mean plasma glucose based on 8-point self-monitored plasma glucose (SMPG) profiles
    5- Change from baseline in variability of 24-hour mean plasma glucose based on 8-point SMPG profiles
    6- Number (%) of patients with hypoglycemia
    7- Number (%) of patients with hyperglycemia with ketosis
    8- Number (%) of patients with adverse events
    1. Percentuale di pazienti con valori HbA1c <7.5% senza alcun episodio di ipoglicemia sintomatica grave e/o documentata (SMPG <54 mg/dl; 3.0 mmol/l) negli ultimi 3 mesi del periodo principale di randomizzazione di 6 mesi;
    2. Variazione della FPG dal basale;
    3. Percentuale di pazienti con glicemia plasmatica a digiuno (FPG) ≤130 mg/dl (7.2 mmol/l) senza alcun episodio di ipoglicemia sintomatica grave e/o documentata (SMPG <54 mg/dl; 3.0 mmol/l) negli ultimi 3 mesi del periodo principale di randomizzazione di 6 mesi;
    4. Variazione dal basale della glicemia plasmatica media nelle 24 ore sulla base di profili SMPG a 8 punti;
    5. Variazione dal basale della variabilità della glicemia plasmatica media nelle 24 ore sulla base di profili SMPG a 8 punti;
    6. Numero (%) di pazienti con ipoglicemia;
    7. Numero (%) di pazienti con iperglicemia con chetosi;
    8. Numero (%) di pazienti con eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- Week 26
    2- Baseline; Week 26
    3- Week 26
    4- Baseline; Week 26
    5- Baseline; Week 26
    6- Up to Month 12
    7- Up to Month 12
    8- Up to Month 12
    1. Settimana 26;
    2. Basale, settimana 26
    3. Settimana 26
    4. Basale, settimana 26
    5. Basale, settimana 26
    6. Fino al mese 12
    7. Fino al mese 12
    8. Fino al mese 12
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 EEA40
    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
    Argentina
    Brazil
    Canada
    Chile
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Latvia
    Mexico
    Poland
    Romania
    Russian Federation
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    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 months26
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months26
    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: 564
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 282
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 282
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Child / adolescents
    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 180
    F.4.2.2In the whole clinical trial 564
    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)
    None
    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 Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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