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    Summary
    EudraCT Number:2015-005101-36
    Sponsor's Protocol Code Number:LPS14584
    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:2021-06-04
    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 number2015-005101-36
    A.3Full title of the trial
    A 24-Week, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of Toujeo¿ and Tresiba¿ in Insulin-Naive Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Oral Antihyperglycemic Drug(s) ¿ GLP-1 Receptor Agonist
    Studio multicentrico, randomizzato, in aperto, a gruppi paralleli, di 24 settimane per il confronto dell'efficacia e della sicurezza di Toujeo¿ e Tresiba¿ in pazienti na¿ve all¿insulina con diabete mellito di tipo 2 non adeguatamente controllato con farmaci antidiabetici orali ¿ agonista del recettore GLP-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Toujeo¿ Versus Tresiba¿ in Insulin-Naive Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral
    Antihyperglycemic Drug(s) ¿ GLP-1 Receptor Agonist
    Efficacia e sicurezza di Toujeo¿ verso Tresiba¿ in pazienti na¿ve all'insulina con diabete mellito di tipo 2 non adeguatamente controllato con farmaci antidiabetici orali ¿ agonista del recettore GLP-1
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberLPS14584
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1177-6327
    A.5.4Other Identifiers
    Name:naNumber:na
    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 GROUPE
    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 GROUPE
    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 number0239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi-aventis.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 nameInsulina Glargine
    D.3.2Product code HOE901 - U300
    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 GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeHOE901-U300
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international 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 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 Tresiba
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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
    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 DEGLUDEC
    D.3.9.1CAS number 844439-96-9
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive namena
    D.3.9.4EV Substance CodeSUB96394
    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
    Type 2 diabetes mellitus
    Diabete mellito di tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    Diabete mellito 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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 demonstrate the noninferiority in the efficacy of Toujeo¿ to Tresiba¿
    in glycated hemoglobin (HbA1c) change.
    Dimostrare la non inferiorit¿ di Toujeo in efficacia rispetto a Tresiba in termini di variazione dell'emoglobina glicata A1c (HbA1c)
    E.2.2Secondary objectives of the trial
    -To assess the effects of the insulin Toujeo¿ in comparison with insulin
    Tresiba¿ on:
    -Change in Fasting plasma glucose (FPG);
    -Change in Fasting self-monitored plasma glucose (SMPG) and 4-point
    SMPG and 8-point SMPG profile;
    -Percentage of patients reaching HbA1c targets <7% or =6.5%;
    -Percentage of patients reaching HbA1c targets <7% or =6.5%
    without severe and/or confirmed hypoglycemia
    -Percentage of patients requiring rescue therapy.
    -To assess the frequency of occurrence and diurnal distribution of
    hypoglycemia by American Diabetes Association (ADA) category of
    hypoglycemia.
    -To assess the safety in each treatment group.
    -To assess the treatment effects in each treatment group on Patient
    Reported Outcomes (PRO).
    - Valutare gli effetti di Toujeo rispetto a Tresiba sui seguenti fattori:
    - Variazione nel glucosio plasmatico a digiuno (FPG)
    - Variazione nel glucosio plasmatico automonitorato a digiuno (SMPG) e nel profilo SMPG a 4 e 8 punti
    - Percentuale di pazienti che raggiungono il target di HbA1c <7% o =6,5%
    - Percentuale di pazienti che raggiungono il target di di HbA1c <7% o =6,5% senza epidosi di ipoglicemia grave e/o confermata
    - Percentuale di pazienti che necessitano della Terapia "Rescue" di salvataggio
    - Valutare l'incidenza e la distribuzione diurna dell'ipoglicemia in base alla categoria di ipoglicemia ( ADA - Associazione Americana Diabete)
    - Valutare la sicurezza in ciascun gruppo di trattamento
    - Valutare gli effetti del trattamento in ciascun gruppo di trattamento sulla base degli esiti riferiti dal paziente (PRO, Patient Reported Outcomes)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adult patients with type 2 diabetes mellitus (T2DM) inadequately controlled with OADs therapy with/without GLP-1 receptor agonist at stable dose for at least 3 months.
    -Signed written informed consent.
    - Pazienti adulti con T2DM non adeguatamente controllato con terapia a base di OAD con/senza antagonista del recettore GLP-1 a dose stabile per almeno 3 mesi;
    - Firma del consenso informato scritto
    E.4Principal exclusion criteria
    -Age <18 years.
    -HbA1c <7.5% or >10.5% (at screening visit).
    -Body mass index (BMI) <25 kg/m^2 or >40 kg/m^2.
    -History of T2DM for less than 1 year before screening.
    -Less than 6 months before screening on OADs treatment and GLP-1 receptor agonist (if taken).
    -Current or previous insulin use except for a maximum of 8 consecutive days or totally 15 days (eg, acute illness, surgery) during the last year
    prior to screening.
    -Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
    -Patient receiving only noninsulin antihyperglycemic drugs not approved
    for combination with insulin according to local labelling/local treatment
    guideline.
    -History of hypoglycemia unawareness or repeated episodes of severe
    hypoglycemia or metabolic acidosis, including hospitalization for diabetic
    ketoacidosis during the last 12 months prior to screening.
    -Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require
    treatment (eg, laser, surgical treatment, or injectable drugs) during the
    study period.
    -End stage renal disease.
    -Any acute or chronic condition that in the opinion of Investigator would
    affect the patient safety, compliance, or study results.
    -Any contraindication to use of Toujeo® or Tresiba® as defined in the national product label, hypersensitivity to Toujeo® or Tresiba® active
    ingredients or one of the excipients.
    -Pregnant or breast-feeding women
    -Età < 18 anni
    - HbA1c <7.5% o >10,5% (alla visita di screening)
    - Indice di massa corporea (BMI) <25kg/m^2 o >40 kg/m^2
    - Anamnesi di T2DM da meno di 1 anno prima dello screening
    - Trattamento con OAD e agonista del recettore GLP-1 (se assunto) meno di 6 mesi prima dello screening
    Uso attuale o precednete dell'insulina, ad eccezione di un uso massimo di 8 giorni consecutivi o 15 giorni in totale (es. malattia acuta, intervento chirurgico) durante l'ultimo anno prima dello screening
    - Inizio dell'assunzione di nuovi farmaci per l'abbassamento del glucosio e/o di farmaci per la perdita di peso negli ultimi 3 mesi prima della visita di screening
    - Paziente che riceve solo farmaci antidiabetici non insulinici non approvati per l'uso combinato con l'insulina conformemente all'etichettatura locale
    - Anamnesi di ipoglicemia asintomatica o ripetuti episodi di grave ipoglicemia o acidosi metabolica, incluso ricovero in ospedale per chetoacidosi diabetica negli ultimi 12 mesi prima dello screening
    - Retinopatia diabetica proliferativa instabile o qualunque altra retinopatia diabetica a rapida progressione o edema maculare con probabile necessità di trattamento (es. laser, trattamento chirurgico o farmaci iniettabili) durante il periodo dello studio
    - Malattia renale allo stadio terminale
    - Qualunque condizione acuta o cronica che, a parere dello sperimentatore, potrebbe influire sulla sicurezza del paziente, sull'aderenza al trattamento o sui risultati dello studio
    - Qualunque controindicaione all'uso di Toujeo o Tresiba conformemente all'etichettatura relativa a ciascun Paese, ipersensibilità ai principi attivi di Toujeo o Tresiba o ad uno degli eccipienti
    - Donne in gravidanza o che allattano al seno
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c
    HbA1c: Variazione dal basale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 24
    Dal basale alla settimana 24
    E.5.2Secondary end point(s)
    1 Change in baseline in HbA1c
    2 Change in FPG from baseline
    3 Change in fasting self-monitoring plasma glucose (SMPG) from baseline
    4 Change in 4-point and 8-point SMPG profiles per time-point from baseline
    5 Change of mean 24-hour plasma glucose from baseline
    6 Change in variability of fasting SMPG and 24 ¿hour plasma glucose from Baseline
    7 Percentage (%) of patients reaching target HbA1c <7% e </= 6,5%
    8 Percentage (%) of patients reaching target <7% e </= 6,5% without severe and/or confirmed hypoglycemia
    9 Percentage (%) of patients with sulphonylurea or meglitinide dose reduction due to hypoglycemia
    10 Percentage of patients requiring a rescue therapy
    11 Change in basal insulin dose ( U and U/kg body weight) from Baseline
    12 Assessment oh hypoglycemia event (ADA category)
    13 Percentage (%) of patients experiencing adverse events
    14 Change in Patient Report Outcomes scores
    1 HbA1C: variazione dal basale
    2 FPG: variazione dal basale
    3 SMPG a digiuno: variazione dal basale
    4 Variazione nei profili SMPG a 4 e 8 punti , per punto temporale, dal basale
    5 Variazione del glucosio plasmatico medio nelle 24 ore dal basale
    6 Cambiamento nella variabilit¿ di SMPG a digiuno e del valore di glucosio plasmatico nelle 24 ore dal basale
    7 Percentuale di pazienti che hanno raggiunto il target di HbA1c <7% e </= 6,5%
    8 Percentuale di pazienti che hanno raggiunto il target di HbA1c <7% e < /=6,5% senza un evento di ipoglicemia grave e/o confermato
    9 Percentuale di pazienti con sulfamiluree o riduzione/sospensione della dose di meglitinide dovuta a ipoglicemia
    10 Percentuale di pazienti che necessitano di ¿terapia di salvataggio¿
    11 Variazione nella dose di insulina basale dal basale (U e U /kg di peso corporeo)
    12 Valutazione degli eventi ipoglicemici (ADA categoria)
    13 Percentuale di pazienti con eventi avversi
    14 Variazione degli esiti riferiti dai pazienti (PRO)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: Baseline to Week 12
    2,3,4,5,6,7,8,11,14: Baseline to Week 12 and Week 24
    9,10,12,13: Baseline to Week 24

    1 Dal basale alla settimana 12
    2,3,4,5,6,7,8,11,14: Dal basale alla settimana 12 e alla settimana 24
    9,10,12,13: Dal basale alla settimana 24
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA73
    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
    Bulgaria
    Croatia
    Czechia
    Denmark
    France
    Greece
    Hungary
    Israel
    Italy
    Romania
    Serbia
    Slovakia
    Slovenia
    Sweden
    Switzerland
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 1380
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 460
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 805
    F.4.2.2In the whole clinical trial 1840
    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
    Nessuno
    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 Decision2016-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
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