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    Summary
    EudraCT Number:2012-004096-38
    Sponsor's Protocol Code Number:EFC12626
    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:2013-01-11
    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 number2012-004096-38
    A.3Full title of the trial
    A randomized, open-label, active-controlled, 3-arm parallel-group, 26- week study comparing the efficacy and safety of lixisenatide to that of insulin glulisine once daily and insulin glulisine three times daily in patients with Type 2 diabetes insufficiently controlled with insulin glargine with or without metformin
    Studio randomizzato, in aperto, con controllo attivo, tre bracci a gruppi paralleli, della durata di 26 settimane per confrontare l'efficacia e la sicurezza di lixisenatide rispetto a insulina glulisina somministrata una volta al giorno e insulina glulisina somministrata tre volte al giorno, in pazienti affetti da diabete di tipo 2 non sufficientemente controllato con insulina glargina con o senza metformina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of lixisenatide versus insulin glulisine on top of insulin glargine with or without metformin in type 2 diabetic patients
    Efficacia e sicurezza di lixisenatide a confronto con insulina glulisina in aggiunta a insulina glargine con o senza metformina in pazienti con diabete di tipo 2.
    A.4.1Sponsor's protocol code numberEFC12626
    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 ET 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-AVENTS RECHERCHE ET DEVELOPPEMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI-AVENTIS 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 number800.226343
    B.5.5Fax number02.3939.4168
    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 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 namelixisenatide
    D.3.2Product code AVE0010
    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 INNlixisenatide
    D.3.9.1CAS number 320367-13-3
    D.3.9.2Current sponsor codeAVE0010
    D.3.9.3Other descriptive namelixisenatide
    D.3.9.4EV Substance CodeSUB32251
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 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 nameLIXISENATIDE
    D.3.2Product code AVE0010
    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 INNLIXISENATIDE
    D.3.9.1CAS number 320367-13-3
    D.3.9.2Current sponsor codeAVE0010
    D.3.9.3Other descriptive nameLIXISENATIDE
    D.3.9.4EV Substance CodeSUB32251
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 3
    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 Apidra SoloStar 100unità/ml soluzione per iniezione in siringa pre-riempita
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULINA GLULISINA
    D.3.9.1CAS number 207748-26-6
    D.3.9.4EV Substance CodeSUB20054
    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 2 Diabetes mellitus.
    Diabete Mellito di Tipo 2.
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes.
    Diabete di Tipo 2.
    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 14.1
    E.1.2Level SOC
    E.1.2Classification code 10027433
    E.1.2Term Metabolism and nutrition disorders
    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 lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin.
    Dimostrare in pazienti affetti da diabete di tipo 2, non adeguatamente controllati, con insulina glargine ± metformina: • rispetto all'insulina glulisina somministrata una volta al giorno, la non inferiorità di lixisenatide in termini di riduzione dell'HbA1c alla Settimana 26; • rispetto all'insulina glulisina somministrata tre volte al giorno, la non inferiorità di lixisenatide in termini di riduzione dell'HbA1c oppure la superiorità di lixisenatide in termini di variazione ponderale alla Settimana 26.
    E.2.2Secondary objectives of the trial
    To compare the treatments/regimens on: • The percentage of patients reaching the target of HbA1c <7% or ≤ 6.5% • Body weight; • Self-Monitored Glucose profiles • Fasting Plasma Glucose (FPG) • Post-prandial plasma glucose /glucose excursions during a standardized meal test (subset of patients) • Daily doses of insulins • Safety and tolerability
    Valutare l'effetto dei tre trattamenti/regimi: la percentuale di pazienti che abbia raggiunto l'obiettivo dell'HbA1c &lt;7% o ≤6,5% ;il peso corporeo; l’auto-monitoraggio del glucosio plasmatico; il glucosio plasmatico a digiuno; il glucosio post-prandiale e le escursioni glicemiche durante il test con pasto standardizzato (per i pazienti che ricevano un'iniezione di farmaco sperimentale prima della colazione; dosi quotidiane di insulina/e. sicurezza e la tollerabilità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1) . • Patients treated with basal insulin for at least 6 months. • Patients treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (ie type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20 %) and ≥20 U/day for at least 2 months prior to visit 1. • Patients treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that can be: metformin (≥1.5g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor. The dose of OADs should be stable for at least 3 months prior to visit 1.
    Pazienti con diabete mellito di tipo 2 diagnosticato almeno un anno prima della visita di screening (V1). Pazienti trattati con insulina basale da almeno 6 mesi. Pazienti trattati da almeno 3 mesi prima della Visita 1 con un regime di insulina basale stabile (ossia tipo di insulina e orario/frequenza delle iniezioni). La dose di insulina deve essere stabile (± 20 %) e ≥20 U/giorno da almeno 2 mesi prima della Visita 1. • Pazienti trattati con insulina basale in monoterapia o in associazione a 1-3 farmaci antidiabetici orali, che possono essere: metformina (≥1,5 g/giorno o massima dose tollerata), una sulfonilurea, un inibitore della dipeptidil-peptidasi 4 (DPP-4). La dose dei farmaci antidiabetici deve essere stabile da almeno 3 mesi prima della Visita 1.
    E.4Principal exclusion criteria
    • At screening: age < legal age of majority • At screening, HbA1c: < 7.5% and > 10.0% for patients treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for patients treated with basal insulin and a combination of oral anti-diabetic drugs which includes a SU and/or a DPP4 inhibitor •Women of childbearing potential with no effective contraceptive method, pregnancy or lactation • Type 1 diabetes mellitus •Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening. •Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness. •Previous treatment with exenatide, liraglutide or any other GLP-1 receptor agonist •At screening, Body Mass Index (BMI) ≤20 or >40 kg/m². •Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening. • Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures. • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery. • At screening resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 95 mmHg • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes) • Contraindication related to metformin (for patient receiving this treatment), insulin glargine, insulin glulisine or lixisenatide. • Patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease, if no treatment with metformin • At screening, amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN) • At screening ALT or AST>3ULN • At screening calcitonin ≥20 pg/ml (5.9 pmol/L) Exclusion Criteria for randomization at the end of the screening period before randomization: • HbA1c <7.0% or >9.0%. • 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L). • Amylase and/or lipase > 3 times ULN.
    Età inferiore alla maggiore età allo screening HbA1c:&lt;7,5% e &gt;10,0% per i pazienti trattati con insulina basale in monoterapia o in associazione alla sola metformina, &lt;7,0% e &gt;10,0% per i pazienti trattati con insulina basale e un'associazione di farmaci antidiabetici orali comprendente una sulfonilurea e/o un inibitore della DPP-4. Donne in età fertile che non fanno uso di contraccettivi, donne in gravidanza o in allattamento Diabete mellito di tipo 1 Trattamento con uno o più agenti ipoglicemizzanti, ad eccezione degli agenti indicati nei criteri di inclusione, entro i tre mesi precedenti lo screening. Precedente trattamento con insulina ad azione breve o rapida, tranne che in relazione a un ricovero ospedaliero o una malattia acuta. Precedente trattamento con exenatide, liraglutide o altri agonisti del recettore GLP-1. Indice di Massa Corporea &lt;20 o &gt;40kg/m2 allo screening Variazione del peso maggiore di 5 kg nei 3 mesi precedenti la visita di screening; utilizzo di farmaci per perdere peso nei 3 mesi precedenti lo screening. Nei 6 mesi precedenti lo screening: anamnesi di infarto del miocardio, ictus o scompenso cardiaco che abbia richiesto l’ospedalizzazione. Procedure pianificate di rivascolarizzazione dell’arteria coronarica, carotidea o periferica. Anamnesi di pancreatite inspiegabile, pancreatite cronica, pancreatectomia, intervento chirurgico/gastrico allo stomaco. Pressione sanguigna sistolica &gt;180mmHg o pressione diastolica &gt; 95mmHg allo screening Anamnesi personale o di familiari stretti di carcinoma midollare della tiroide o condizione genetica predisponente al carcinoma midollare della tiroide (ad es. sindrome della neoplasia endocrina multipla). Controindicazione correlata a metformina (per i pazienti che ricevono questo trattamento), insulina glargine, insulina glulisina o lixisenatide. Pazienti con grave insufficienza renale (clearance della creatinina inferiore a 30 ml/min) o nefropatia allo stadio terminale. Esami di laboratorio al momento dello screening, tra cui: - amilasi e/o lipasi &gt;3 volte il limite superiore dei normali intervalli di intervalli di laboratorio (ULN); - ALT o AST&gt; 3 ULN; - calcitonina ≥20 pg/ml (5,9 pmol/L). criteri di esclusione per la per la randomizzazione al termine del periodo di screening • HbA1c &lt;7,0% o &gt;9,0%. • SMPG medio a digiuno relativo ai 7 giorni precedenti alla Visita 8 (Settimana 0, giorno 1) &gt;140 mg/dL (7,8 mmol/L). • amilasi e/o lipasi &gt;3 volte ULN.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in HbA1c - Change from baseline in body weight
    variazione rispetto al basale dell'HbA1c. Variazione del peso corporeo rispetto al basale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 26
    settimana 26.
    E.5.2Secondary end point(s)
    - Percentage of patients reaching HbA1c <7% - Percentage of patients reaching HbA1c ≤6.5% - Change in body weight from baseline - Percentage of patients with no weight gain. XML File Identifier: ZST1Vz6pQ1H4etlbEZ8sryaFr/o= Page 20/30 - Change in 7-point SMPG profiles from baseline - Change from baseline in FPG - Change from baseline in post-prandial glucose /glucose excursions during a standardized meal test (subset of patients) - Change from baseline in insulin glargine dose - Daily dose of insulin glulisine - Total daily dose of insulins - Documented (PG <60 mg/dl) symptomatic hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year) - Severe hypoglycemia
    Percentuale di pazienti che raggiungono l'obiettivo dell'HbA1c <7%; Percentuale di pazienti che raggiungono l'obiettivo dell'HbA1c <=6.5%; Variazione del peso corporeo rispetto al basale. Percentuale di pazienti che non aumentano di peso. Variazione nei profili a 7 punti SMPG rispetto al basale. Variazione rispetto al basale del glucosio plasmatico a digiuno. Variazione rispetto al basale del glucosio post-prandiale e le escursioni glicemiche durante il test con pasto standardizzato. variazione rispetto la basale nella dose di insulina glargine . Dose giornaliera di insulina glulisina. Dose giornaliera totale di insulina. Ipoglicemia sinotmatica documentata (PG <60mg/dl) (percentuale di pazienti con almeno un epidsodio, numero di eventi per paziente per anno). Ipoglicemia grave
    E.5.2.1Timepoint(s) of evaluation of this end point
    - week 26 - 26 weeks for: Documented (PG <60 mg/dl) symptomatic hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year) and Severe hypoglycemia
    settimana 26 26 settimane per: Ipoglicemia sinotmatica documentata (PG <60mg/dl) (percentuale di pazienti con almeno un epidsodio, numero di eventi per paziente per anno) e ipoglicemia grave
    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 Yes
    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 Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA116
    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
    Canada
    Chile
    Mexico
    Russian Federation
    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 years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months19
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 155
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 855
    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)
    No specific plan for treatment or care after the subject has ended the participation in the trial.
    nESSUN TRTTAMENTO SPECIFICO AL TERMINE DELLA PARTECIPAZIONE ALLO 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 Decision2013-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-23
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