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    Summary
    EudraCT Number:2016-004906-32
    Sponsor's Protocol Code Number:EFC15166
    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:2020-11-05
    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 number2016-004906-32
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients with Type 2 Diabetes Mellitus and Severe Renal Impairment who have Inadequate Glycemic Control
    Studio randomizzato, in doppio cieco, controllato verso placebo, a 3 bracci, a gruppi paralleli, della durata di 52 settimane, multicentrico, teso a valutare l'efficacia e la sicurezza di sotagliflozin in pazienti con diabete mellito di tipo 2 e insufficienza renale grave che presentano un controllo glicemico inadeguato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Safety and Effects of Sotagliflozin Dose 1 and Dose 2 on Glucose Control in Patients with Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
    Studio di Sicurezza ed Efficacia di Sotagliflozin nelle Dosi 1 e 2 sul controllo del glucosio in pazienti con Diabete di tipo 2, con insufficienza renale grave e controllo inadeguato dello zucchero nel sangue
    A.3.2Name or abbreviated title of the trial where available
    SOTA-CKD4
    SOTA-CKD4
    A.4.1Sponsor's protocol code numberEFC15166
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1190-7589
    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 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 nameSotaglifozin
    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.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
    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
    Chronic kidney disease stage 4
    Diabete Mellito di tipo II ed insufficienza renale cronica di grado 4
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    Chronic kidney disease stage 4
    Diabete mellito di tipo 2 insufficienza renale cronica grado 4
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10076411
    E.1.2Term Chronic kidney disease stage 4
    E.1.2System Organ Class 100000004857
    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 superiority of sotagliflozin dose 1 versus placebo
    with respect to hemoglobin A1c (HbA1c) reduction in patients with Type
    2 diabetes who have inadequate glycemic control and severe renal impairment
    Dimostrare la superiorit¿ di sotagliflozin dose 1 mg rispetto al placebo nella riduzione dell'emoglobina A1c (HbA1c) in pazienti con diabete di tipo 2 (T2D) che presentano controllo glicemico inadeguato e insufficienza renale grave.
    E.2.2Secondary objectives of the trial
    -To assess the effects of sotagliflozin dose 2 versus placebo based on change from baseline in HbA1c
    -To assess the effects of sotagloflozin doses 1 and 2 versus placebo
    -To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo
    -Valutare gli effetti di sotagliflozin dose 2 rispetto al placebo in base a: Variazione di HbA1c dal basale
    -Valutare gli effetti di sotagliflozin dosi 1 e 2 rispetto al placebo
    -Valutare la sicurezza di sotagliflozin dosi 1 e 2 rispetto al placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients with T2D (drug-naïve or on antidiabetic therapy) and documented severe renal insufficiency - CKD4 - defined by an eGFR equation (based on the 4 variable modification of diet in renal disease [MDRD] equation) of =15 and <30 mL/min/1.73 m2.
    -Signed written informed consent to participate in the study in accordance with local regulations.
    -Pazienti con T2D (naïve ai farmaci o trattati con terapia antidiabetica) e insufficienza renale grave,( malattia renale cronica [CKD, chronic kidney disease]) documentata, definita di stadio 4 tramite un'equazione eGFR (basata su MDRD a 4 variabili) =15 e <30 ml/min/1,73 m2
    -Firma del consenso informato scritto per partecipare allo studio in conformità alle normative locali.
    E.4Principal exclusion criteria
    -At the time of screening, age <18 years.
    -Hemoglobin A1c (HbA1c) <7% or >11%.
    -Type 1 diabetes.
    -Women of childbearing potential (WOCBP) 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
    -Treatment with an SGLT2 inhbitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
    -Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes with result in a short life expectancy will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
    -Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.
    Al momento dello screening, età <18 anni
    - HbA1c <7% o HbA1c >11%
    - Diabete mellito di tipo 1
    -Donne in grado di procreare che non intendono utilizzare metodi contraccettivi a elevata efficacia durante il periodo di trattamento e il periodo di follow-up dello studio, o che non possono o non sono disposte a sottoporsi al test di gravidanza , durante lo studio
    -Utilizzo di un inibitore SGLT2 selettivo (ad es., canagliflozin, dapagliflozin o empagliflozin) nei 12 mesi precedenti la sperimentazione
    -Pazienti con ipertensione non controllata anemia grave, malattie cardiovascolari gravi, ad esempio infarto o tumore maligno attivo o altra malattia con aspettativa di vita breve che,secondo lo sperimentatore, precluda la partecipazione sicura a questo studio o ostacoli l'attuazione del protocollo o l'interpretazione dei risultati dello studio.
    -Complicanze degli arti inferiori (come ulcere della pelle, infezione, osteomielite e cancrena) identificate durante il periodo di Screening e che richiedono ancora trattamento alla Randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c
    Variazione di 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 HbA1c : Change from Baseline to Week 26 in HbA1c comparing sotaglifozin dose 2 versus placebo
    - Change in Fasting Plasma Glucose (FPG) : Change from Baseline to Week 26 in FPG (doses 1 e 2)
    - Change in Systolic Blood Pressure (SBP) for patients with SBP =130 mmHg : Change from Baseline in SBP at Week 12 for patients with SBP greater than or equal to 130 mmHg (doses 1 and 2)
    - Change in SBP : Change from Baseline at Week 12 in SBP for all patients (doses 1 and 2)
    - Change in body weight : Change from Baseline at Week 26 in body weight(doses 1 and 2)
    - Change in urinary albumin-to-creatinine ratio (UACR) : Percentage change in the UACR from Baseline to Week 26 for patients with a UACR> 30mg/g at baseline (doses 1 and 2)
    - Patients with HbA1c < 6.5% : Percentage of patients with HbA1c < 6.5% at Week 26(doses 1 and 2)
    - Patients with HbA1c < 7.0% : Percentage of patients with HbA1c < 7.0% at Week 26(doses 1 and 2)
    - Adverse events : Number of patients with adverse events up to Week 52(doses 1 and 2)
    -Variazione di HbA1c:Variazione dal basale alla settimana 26 di HbA1c confrontando la dose 2 di sotaglifozin rispetto al placebo .
    - Variazione della glicemia a digiuno (FPG): Variazione dal basale alla settimana 26 della FPG (dosi 1 e 2)
    - Variazione della pressione sistolica (SBP) in pazienti con SBP =130 mmHg: Variazione di SBP dal basale alla settimana 12 in pazienti con SBP maggiore o uguale =130 mmHg (dosi 1 e 2)
    - Variazione di SBP : Variazione di SBP dal basale alla settimana 12 in tutti i pazienti(dosi 1 e 2)
    - Variazione del peso corporeo : Variazione dal basale alla settimana 26 del peso corporeo(dosi 1 e 2)
    - Variazione del rapporto urinario albumina- creatinina (UACR): Variazione della percentuale di (UACR)dal baseline alla settimana 26 in pazienti con UACR > 30mg/g al baseline(dosi 1 e 2).
    - Pazienti con HbA1c < 6.5%: Percentuale di pazienti con HbA1c < 6.5% alla settimana 26(dosi 1 e 2)
    - Pazienti con HbA1c < 7.0%: Percentuale di pazienti con HbA1c < 7.0% settimana 26 (dosi 1 e 2)
    - Eventi avversi:Numero di pazienti con eventi avversi fino alla settimana 52 (dosi 1 e 2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change in HbA1c : Baseline to Week 26
    - Change in Fasting Plasma Glucose (FPG) : Baseline to Week 26
    - Change in Systolic Blood Pressure (SBP) for patients with SBP =130 mmHg : Baseline to Week 12 - Change in SBP : Baseline to Week 12
    - Change in body weight : Baseline to Week 26 - Change in urinary albumin-to-creatinine ratio (UACR) : Baseline to Week 26
    - Patients with HbA1c < 6.5% : Week 26 - Patients with HbA1c < 7.0% : Week 26
    - Adverse events : Week 52
    - Variazione di HbA1c: dal basale alla settimana 26.
    - Variazione della glicemia a digiuno (FPG): dal basale alla settimana 26
    - Variazione della pressione sistolica (SBP) in pazienti con SBP =130 mmHg: dal basale alla settimana 12
    - Variazione di SBP : dal basale alla settimana 12
    - Variazione del peso corporeo : dal basale alla settimana 26
    - Variazione del rapporto urinario albumina- creatinina : dal baseline alla settimana 26
    - Pazienti con HbA1c < 6.5%: settimana 26
    - Pazienti con HbA1c < 7.0%: settimana 26
    - Eventi avversi: settimana 52
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Brazil
    Colombia
    Germany
    Hungary
    Israel
    Italy
    Mexico
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Ukraine
    United States
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 413
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 412
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 254
    F.4.2.2In the whole clinical trial 825
    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 Decision2017-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
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