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    Summary
    EudraCT Number:2016-001803-22
    Sponsor's Protocol Code Number:EFC14867
    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:2021-02-09
    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 number2016-001803-22
    A.3Full title of the trial
    A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin compared to Empagliflozin, and Placebo in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin
    Studio randomizzato, in doppio cieco, controllato, a gruppi paralleli, multicentrico, della durata di 26 settimane, teso a valutare l'efficacia e la sicurezza di Sotagliflozin rispetto a Empagliflozin e placebo in pazienti affetti da diabete di tipo 2 con controllo inadeguato della glicemia in terapia con inibitore della dipeptidil peptidasi 4 (DPP4(i)) 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 Sotagliflozin versus Placebo and Empagliflozin in Subjects with Type 2 Diabetes Mellitus who have Inadequate Glycemic Control while taking a DPP4 Inhibitor Alone or with Metformin
    Efficacia e sicurezza di Sotaglifozin verso Placebo e Empagliflozin in pazienti con diabete di tipo 2 che hanno un controllo inadeguato della glicemia mentre prendono un inbitore della dipeptidil peptidasi 4, con o senza metformina
    A.3.2Name or abbreviated title of the trial where available
    SOTA-EMPA
    SOTA-EMPA
    A.4.1Sponsor's protocol code numberEFC14867
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1190-7607
    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 E DEVELOPPEMENT
    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 e Developpement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi SPA
    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.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 nameSotagliflozin
    D.3.2Product code [SAR439954]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSOTAGLIFLOZIN
    D.3.9.1CAS number 1018899-04-1
    D.3.9.2Current sponsor codeSAR439954
    D.3.9.4EV Substance CodeSUB179285
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 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 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 JARDIANCE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 100 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL 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 nameNA
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMPAGLIFLOZIN
    D.3.9.1CAS number 864070-44-0
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameEMPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB35915
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    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
    Demonstrate the superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in patients with Type 2 diabetes (T2D) who have inadequate glycemic control on a Dipeptidyl Peptidase 4 inibitor DPP4(i) with or without metformin.
    Dimostrare la superiorità di Sotagliflozin rispetto al placebo nella riduzione dell'emoglobina A1c (HbA1c) in pazienti con diabete di tipo 2 (Type 2 diabete, T2D) che presentano un controllo glicemico inadeguato in terapia con un inibitore della dipeptidil peptidasi 4 [Dipeptidyl Peptidase 4 Inhibitor, DPP4(i)] con o senza metformina.
    E.2.2Secondary objectives of the trial
    - To demonstrate non-inferiority of sotagliflozin versus empagliflozin on HbA1c reduction.
    - To demonstrate the superiority of sotagliflozin versus placebo on 2-hour postprandial glucose (PPG) reduction, fasting plasma glucose (FPG)
    reduction, body weight reduction, on the proportion of patients with HbA1c <6.5% and <7.0%, and on sitting systolic blood pressure (SBP) reduction.
    -To demonstrate the superiority of sotagliflozin versus empagliflozin on HbA1c reduction and sitting SBP reduction.
    - To evaluate the safety of sotagliflozin versus empagliflozin, and placebo, throughout the trial.
    -Dimostrare la non inferiorità di Sotagliflozin rispetto Empagliflozin sulla riduzione dell'emoglobina A1c (HbA1c)
    -Dimostrare la superiorità di Sotagliflozin rispetto al placebo sulla riduzione del glucosio post-prandiale (PPG) a 2 ore, sulla riduzione della glicemia plasmatica a digiuno (FPG), sulla riduzione del peso corporeo, sulla riduzione della percentuale dei pazienti con HbA1c < 6,5% e < 7%, e sulla variazione della riduzione della pressione sanguigna sistolica (SBP) da seduti.
    -Dimostrare la superiorità di Sotagliflozin rispetto Empagliflozin sulla riduzione dell' HbA1c e sulla riduzione della pressione sanguinia sistolica da seduti.
    - Valutare la sicurezza di Sotagliflozin rispetto a Empagliflozin e placebo durante lo studio
    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: Ambulatory Blood Pressure Monitoring substudy: - date: 29 september 2017 - version: 1 - Objective: To compare the effect of sotagliflozin, empagliflozin and placebo in a subset of patients based on:
    -24-hour average SBP and dispotic blood pressure (DBP).
    -Average adjusted awake time blood pressure (BP) as measured by SBP and DBP with adjustment based on actigraphy.
    -Average adjusted sleeping time BP as measured by SBP and DBP with adjustment based on actigraphy

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio di monitoraggio Ambulatoriale della pressione sanguigna - data: 29 settembre 2017 - versione: 1- Obiettivo: Confrontare l'effetto di sotagliflozin, empagliflozin e placebo in un sottogruppo di pazienti in base a:
    -sulla media di SBP e pressione sanguinia diastolica (SDP) nelle 24 ore;
    -Tempo medio regolato dalla pressione sanguinia del tempo da sveglio calcolata misurando SBP e DBP, con una regolazione basata sull'actigrafia.
    -Pressione sanguinia media del sonno calcolata misurando SBP e DBP con una regolazione basata sull'actigrafia.
    E.3Principal inclusion criteria
    -Patients with Type 2 Diabetes on Dipeptidyl peptidase-4 inhibitors(DPP4(i)) with or without metformin at a stable dose for at least 12 weeks prior to Screening Visit. Metformin dose will be =1500 mg per day (or maximum tolerated dose [documented]). DPP4(i) dose must be the appropriate dose as per local label.
    -Signed written informed consent.
    - • Pazienti con diabete di tipo 2 in terapia con DPP4(i) con o senza metformina a una dose stabile per almeno 12 settimane prima della visita di screening. La dose di metformina sarà =1500 mg/die (o la dose massima tollerata, documentata). La dose di DPP4(i) deve essere la dose appropriata secondo l'etichetta locale.
    -Modulo di consenso informato scritto firmato.
    E.4Principal exclusion criteria
    -Body mass index (BMI) =20 kg/m² or >45 kg/m² at Screening.
    -Use of any antidiabetic drug other than DPP4 inhibitors and metformin within 12 weeks preceding the Screening Visit.
    -Patients who have previously participated in any clinical trial of sotagliflozin/LX4211.
    -Use of a selective Sodium-glucose co-transporter type 2 (SGLT2) inhibitor (eg, canagliflozin, dapagliflozin, or empagliflozin) within 3 months prior to screening visit.
    -Patients with severe anemia, severe cardiovascular disease (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or
    interpretation of the study results difficult.
    -Current diagnosis of chronic hepatitis, and/or other clinically active liver disease requiring treatment.
    -Patients with contraindication to empagliflozin as per local labeling.
    -Patients with contraindication to metformin as per local labeling.
    -Hemoglobin A1c <7.0% or >11.0% at Screening (central laboratory).
    -Fasting plasma glucose >270 mg/dL (>15.0 mmol/L) measured by the central laboratory at Screening (Visit 1), and confirmed by a repeat test (>270 mg/dL [>15.0 mmol/L]) before Randomization.
    -Previous use of any types of insulin for >1 month (except for treatment of gestational diabetes).
    -Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.
    -Women of childbearing potential not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
    -Mean of 3 separate blood pressure (BP) measurements >180 mmHg systolic blood pressure (SBP) or >100 mmHg diastolic blood pressure (DBP).
    -History of hypertensive crisis resulting in emergency medical care within 12 weeks prior to Screening Visit.
    -Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the screening period, and still requiring treatment at randomization;
    -Laboratory findings with the central laboratory tests at Visit 1:
    -Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal laboratory range (ULN);
    -Total bilirubin >1.5 times the ULN (except in case of Gilbert's syndrome);
    -Neutrophils <1 500/mm3 (or according to ethnic group) and/or platelets <100 000/mm3;
    -Amylase and/or lipase >3 times the ULN;
    -Patients with renal impairment as defined by the estimated glomerular filtration rate (eGFR) criterion that precludes initiation of empagliflozin as per the approved local label (eg, <45 mL/min/1.73 m2 in US; <60 mL/min/1.73 m2 in EU).
    -Secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome).
    -If the patient is on hypertensive medications, the antihypertensive has been changed in the 8 weeks prior to Screening (new drug or new dose).
    - Indice di massa corporea (body mass index, BMI) =20 kg/m² o >45 kg/m² allo screening
    -Utilizzo di farmaci antidiabetici diversi da DPP4(i) e metformina nelle 12 settimane precedenti la visita di screening.
    -Pazienti che hanno partecipato in precedenza a sperimentazioni cliniche su sotagliflozin/LX4211.
    -Utilizzo di un inibitore selettivo del trasportatore di sodio-glucosio di tipo 2 (sodium-glucose cotransport Type 2, SGLT2) (ad es. canagliflozin, dapagliflozin o empagliflozin) nei 3 mesi precedenti la visita di screening.
    -Pazienti con anemia grave, malattia cardiovascolare (inclusa insufficienza cardiaca congestizia di classe IV secondo la New York Heart Association), respiratoria, epatica, neurologica, psichiatrica grave o tumore maligno attivo o altra patologia sistemica maggiore o pazienti con aspettativa di vita breve che, secondo lo sperimentatore, precludano la partecipazione sicura a questo studio o rendano difficile l’attuazione del protocollo o l’interpretazione dei risultati dello studio.
    -Diagnosi attuale di epatite cronica, e/o altre patologie epatiche clinicamente attive che richiedano un trattamento.
    -Pazienti per i quali sia controindicato l'uso di empagliflozin secondo l'etichettatura locale
    -Pazienti per i quali sia controindicato l'uso di metformina secondo l'etichettatura locale
    -Emoglobina A1c <7,0% o >11,0% allo screening (laboratorio centrale)
    -glicemia plasmatica a digiuno FPG >270 mg/dl (>15,0 mmol/l) misurata dal laboratorio centrale allo screening (visita 1) e confermata con una ripetizione del test [>270 mg/dl (>15,0 mmol/l)] prima della randomizzazione.
    -Uso precedente di qualsiasi tipo di insulina per >1 mese (eccetto per il trattamento del diabete gestazionale).
    -Gravidanza (confermata da un test di gravidanza su siero allo screening) o allattamento al seno.
    -Donne in grado di procreare che non intendono utilizzare metodi contraccettivi altamente efficaci durante il periodo di trattamento dello studio e il periodo di follow-up, o che non intendono o non possono sottoporsi a un test di gravidanza durante lo studio.
    -Media di 3 misurazioni distinte di pressione sanguinia (BP) >180 mmHg pressione sanguinia sistolica (SBP) o >100 mmHg pressione sanguinia diastolica (DBP)
    -Storia di crisi ipertensive con richiesta di cure mediche d'emergenza nelle 12 settimane precedenti lo screening.
    - Complicanze alle estremità inferiori (quali ulcere alla pelle, infezione, osteomielite e gangrena) identificate durante il periodo di screening, e che ancora richiedono trattamento alla randomizzazione;
    -Riscontri di laboratorio per i test del laboratorio centrale alla visita 1:
    - Alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST) >3 volte il limite superiore dell'intervallo di normalità (ULN) del laboratorio
    - Bilirubina totale >1,5 volte x ULN (tranne in caso di sindrome di Gilbert)
    - Neutrofili <1.500/mm3 (o secondo l'etnia) e/o piastrine <100.000/mm3
    - Amilasi e/o lipasi >3 volte x ULN
    - Pazienti con insufficienza renale, come definita dal criterio di tasso stimato di filtrazione glomerulare (eGFR), che preclude l'inizio del trattamento con empagliflozin secondo l'etichetta locale approvata (ad es., <45 ml/min/1,73 m2 negli Stati Uniti; <60 ml/min/1,73 m2 nell'UE).
    -Ipertensione secondaria di qualsiasi eziologia (ad es., patologia renovascolare, feocromocitoma, sindrome di Cushing)
    -In caso di paziente in trattamento antipertensivo, variazione del medicinale (nuovo farmaco o nuova dose) nelle 8 settimane precedenti lo screening
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c: Absolute change from baseline to week 26 in Hemoglobin A1 (HbA1c)
    Variazione emoblogina A1c (HbA1c): Variazione assoluta dal basale alla settimana 26 dell' HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to week 26
    Dal basale alla settimana 26
    E.5.2Secondary end point(s)
    Change in sitting SBP in patients with SBP =130 mmHg at Baseline : Absolute change from baseline to week 12 in sitting systolic blood pressure (SBP); Change in 2-hour PPG following a MMTT: Absolute change in 2-hour post prandial glucose (PPG) following a mixed meal tolerance test (MMTT) from baseline to week 26; Change in FPG: Absolute change in fasting plasma glucose (FPG) from baseline to week 26; Change in body weight: Absolute change in body weight from baseline to week 26; Patients with HbA1c <6.5%: Proportion of patients with Hemoglobin A1c (HbA1c) <6.5% at week 26; Patients with HbA1c <7.0%: Proportion of patients with Hemoglobin A1c (HbA1c) <7.0% at week 26; Change in sitting SBP in all patients: Absolute change from baseline to week 12 in sitting systolic blood pressure (SBP) in all patients
    Variazione nella pressione sanguinia sistolica (SBP) da seduti in pazienti con SBP = 130 mmHg al basale:
    Variazione assoluta della pressione sanguinia sistolica da seduti dal basale alla settimana 12; Variazione della glicemia postprandiale (PPG) a 2 ore dopo un test di tolleranza ai pasti misti (MMTT): Variazione assoluta della PPG a 2 ore dopo un MMTT dal basale alla settimana 26; Variazione della glicemia plasmatica a digiuno (FPG): Variazione assoluta della FPG dal basale alla settimana 26 ; Variazione del peso corporeo: Variazione assoluta del peso corporeo dal basale alla settimana 26; Pazienti con emoglobina A1c (HbA1c) < 6.5 %: poercentuale di pazienti con HbA1c < 6.5 % alla settimana 26; Pazienti con emoglobina A1c (HbA1c) < 7.0 %: percentuale di pazienti con HbA1c < 7.0 alla settimana 26; Variazione della pressione sanguinia sistolica (SBP) da seduti in tutti i pazienti: Variazione assoluta della SBP da seduti dal basale alla settimana 12 nella SBP in tutti i pazienti
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to week 12; Baseline to week 26; Baseline to week 26; Baseline to week 26; At week 26; At week 26; Baseline to week 12
    Dal basale alla settimana 12; Dal basale alla settimana 26; Dal basale alla settimana 26; Dal basale alla settimana 26; Alla settimana 26; Alla settimana 26; Dal basale alla settimana 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 Yes
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    placebo - e controllo attivo, doppio cieco
    placebo - and active-controlled, double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Jardiance
    Jardiance
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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
    Canada
    Mexico
    Russian Federation
    United States
    Bulgaria
    France
    Italy
    Latvia
    Slovakia
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state61
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 530
    F.4.2.2In the whole clinical trial 1400
    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 Decision2018-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
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