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    Summary
    EudraCT Number:2015-001709-15
    Sponsor's Protocol Code Number:LX4211.1-312-T1DM
    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:2018-02-28
    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 number2015-001709-15
    A.3Full title of the trial
    "A Phase 3, Randomized, Double-blind, Placebo controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes"
    "Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, multicentrico per valutare il vantaggio clinico netto di Sotagliflozin in aggiunta alla terapia insulinica nel diabete di tipo 1"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine the advantage of Sotagliflozin in addition to Insulin therapy in patients with Type 1 Diabetes
    Studio per esaminare il vantaggio di Sotagliflozin in aggiunta alla terapia insulinica in pazienti con diabete di tipo 1
    A.3.2Name or abbreviated title of the trial where available
    LX4211.1-312-T1DM
    LX4211.1-312-T1DM
    A.4.1Sponsor's protocol code numberLX4211.1-312-T1DM
    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 SponsorLEXICON PHARMACEUTICALS INC.
    B.1.3.4CountryUnited States
    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 supportLexicon Pharmaceuticals, Inc.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLexicon Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointSenior Medical Director
    B.5.3 Address:
    B.5.3.1Street Address8800 Technology Forest Place
    B.5.3.2Town/ cityThe Woodlands, Texas
    B.5.3.3Post codeTX 77381-1160
    B.5.3.4CountryUnited States
    B.5.4Telephone number+01 832 702 6527
    B.5.5Fax number+01 832 442 5917
    B.5.6E-mailssawhney@lexpharma.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 LX4211
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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 placeboCoated tablet
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 Diabetes Mellitus
    Diabete mellito di Tipo 1
    E.1.1.1Medical condition in easily understood language
    High sugar levels in the blood
    Elevati livelli di zucchero nel sangue
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superiority of sotagliflozin 400 mg versus placebo in the proportion of patients with glycosylated A1C <7.0% at Week 24 and no episode of severe hypoglycemia and no episode of diabetic ketoacidosis (DKA) after randomization.
    Dimostrare la superiorità di sotagliflozin 400 mg rispetto al placebo nella proporzione di pazienti con emoglobina glicosilata A1C (A1C) <7,0% alla Settimana 24 e nessun episodio di ipoglicemia grave o di chetoacidosi diabetica (DKA) dopo la randomizzazione.
    E.2.2Secondary objectives of the trial
    To evaluate the change from Baseline of sotagliflozin versus placebo in hierarchical order on the following:
    • A1C
    • Body weight
    • Systolic blood pressure (SBP)
    • Bolus insulin dose
    Valutare la variazione dal basale di sotagliflozin rispetto al placebo in ordine gerarchico relativamente a:
    • A1C
    • Peso corporeo
    • Pressione sistolica (PAS)
    • Dose del bolo di insulina
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Objective: To evaluate satiety (appetite) in a subset of enrolled patients.
    The instrument used will be the Patient Satiety Daily Diary (PSDD). Up to 280 patients (140 per treatment group) will be recruited for this substudy.
    The patients will be instructed to complete the paper diary each day, before the first meal of the day for the last 2 weeks of the double-blind Treatment Period (ie, during Week 23 and during Week 24, a total of 14 days). The diaries will be returned to the site at the visit scheduled for the end of Week 24.
    Obiettivo: Valutare la sazietà (appetito) in un sottoinsieme di pazienti arruolati.
    Lo strumento utilizzato sarà il Patient Satiety Daily Diary (PSDD). Fino a 280 pazienti (140 per gruppo di trattamento) saranno reclutati per questo sottostudio.
    I pazienti saranno istruiti a compilare il diario cartaceo ogni giorno, prima del primo pasto della giornata per le ultime due settimane del Periodo di Trattamento in doppio cieco (ovvero, durante la Settimana 23 e la Settimana 24, per un totale di 14 giorni). I diari saranno restituiti al centro in occasione della visita programmata per la fine della Settimana 24.
    E.3Principal inclusion criteria
    1) Patient has given written informed consent to participate in the study in accordance with local regulations
    2) Adult patients 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent
    3) Patients are being treated with insulin(s) or insulin analog(s)
    4) Non-fast acting insulin dose is stable (±20%) for 2 weeks prior to the Screening Visit
    5) At the Screening Visit, A1C must be between 7.0% and 11.0%, inclusive
    6) BMI ≥18.5 kg/m2
    7) Must be willing and able to perform SMBG and complete the study diary as required per protocol
    8) Females of childbearing potential must use an adequate method of contraception to avoid pregnancy throughout the duration of the study and for 30 days after the last dose of study drug. Females of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Postmenopause is defined as no menses for ≥12 months without another cause. For females with questionable menopausal history (eg, irregular menstrual periods and age >40 years) a documented serum follicle-stimulating hormone (FSH) level must be ≥30 mIU/mL.
    9) Females of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study drug. In the case of positive urine pregnancy testing, a negative serum sample for pregnancy testing, to confirm that the patient is not pregnant, must be obtained prior to start of study.
    1) Il paziente deve aver rilasciato un consenso informato scritto a partecipare allo studio in conformità alle normative locali
    2) Pazienti adulti di almeno 18 anni di età con diagnosi di T1D confermata formulata almeno 1 anno prima del consenso informato
    3) Pazienti in trattamento con insulina(e) o analogo(ghi) dell'insulina
    4) La dose di insulina ad azione lenta è stabile (± 20%) per 2 settimane prima della visita di screening
    5) Alla visita di screening, l'A1C deve essere tra 7,0% e 11,0% compresi
    6) IMC ≥18,5 kg/m2
    7) Disponibilità e capacità di eseguire l'SMBG e compilare il diario dello studio, come richiesto dal protocollo
    8) Le donne in età fertile devono impiegare un metodo contraccettivo adeguato per evitare una gravidanza per tutta la durata dello studio e per 30 giorni dopo l'ultima dose del farmaco in studio. Per donne in età fertile si intendono tutte le donne che hanno avuto il menarca e che non sono state sottoposte a sterilizzazione chirurgica riuscita (isterectomia, legatura bilaterale delle tube o ovariectomia bilaterale) o che non sono in post-menopausa. Per post-menopausa s'intende nessun ciclo per ≥12 mesi senza altre cause. Per le donne con anamnesi post-menopausa dubbia (ad esempio, periodi mestruali irregolari ed età > 40 anni), il livello documentato dell'ormone follicolo-stimolante (FSH) nel siero deve essere ≥ 30 mIU/ml.
    9) Le donne in età fertile devono presentare un test di gravidanza nel siero o nelle urine negativo prima dell'inizio della somministrazione del farmaco in studio. In caso di test di gravidanza nelle urine positivo, prima dell'inizio dello studio occorrerà effettuare un prelievo per eseguire un test di gravidanza nel siero che dovrà dare esito negativo.
    E.4Principal exclusion criteria
    1) Therapies and/or medications
    a) Use of antidiabetic agent other than insulin(s) or insulin analog(s) at the time of screening (any medication other than insulin or insulin analog used for treatment of T1D must be washed out for at least 8 weeks prior to the Screening Visit)
    b) Any prior exposure to sotagliflozin
    c) Use of SGLT inhibitors within 8 weeks prior to Screening.
    d) Chronic systemic corticosteroid use, defined as any dose of systemic corticosteroid taken for more than 4 consecutive weeks within the 6 months prior to the Screening Visit.
    2) Diabetes-related conditions:
    a) Type 2 diabetes mellitus or severely uncontrolled T1D as determined by the Investigator
    b) History of severe hypoglycemic event within 1 month prior to the Screening Visit
    c) History of DKA or nonketotic hyperosmolar state within 1 month of Screening OR ≥2 episodes of DKA or nonketotic hyperosmolar state within 6 months of Screening
    1) Terapie e/o farmaci
    a) Uso di un agente antidiabetico diverso da insulina(e) o analogo(ghi) dell'insulina al momento dello screening (qualsiasi farmaco diverso dall'insulina o da un analogo dell'insulina usato per il trattamento del T1D deve essere soggetto a un periodo di washout di almeno 8 settimane prima della visita di screening)
    b) Qualsiasi esposizione precedente a sotagliflozin
    c) Uso di inibitori dell’SGLT nelle 8 settimane prima dello screening.
    d) Uso cronico di corticosteroidi sistemici, definito come qualsiasi dose di corticosteroidi sistemici assunta per più di 4 settimane consecutive nei 6 mesi che precedono la visita di screening.
    2) Patologie correlate al diabete:
    a) Diabete mellito di tipo 2 o T1D grave non controllato secondo valutazione dello sperimentatore
    b) Anamnesi di evento ipoglicemico grave nel mese che precede la visita di screening
    c) Anamnesi di DKA di stato iperosmolare non chetosico entro 1 mese dallo screening OPPURE ≥2 episodi di DKA o di stato iperosmolare non chetosico nei 6 mesi che precedono la visita di screening
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate the superiority of sotagliflozin 400 mg versus placebo in the proportion of patients with A1C <7.0% at Week 24 and no episode of severe hypoglycemia and no episode of DKA after randomization when used as an adjunct in normal weight and overweight/obese adult patients with T1D who have inadequate glycemic control with insulin therapy.
    Dimostrare la superiorità di sotagliflozin 400 mg rispetto al placebo nella proporzione di pazienti con A1C <7,0% alla Settimana 24 e nessun episodio di ipoglicemia grave nè di DKA dopo la randomizzazione quando impiegato in aggiunta in pazienti adulti normopeso e sovrappeso/obesi con T1D che hanno un controllo glicemico inadeguato con la terapia insulinica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 24
    Alla Settimana 24
    E.5.2Secondary end point(s)
    To be measured as change from Baseline in sotagliflozin 400 mg compared to placebo for each of the following:
    2.1) A1C at Week 24
    2.2) Body weight at Week 24 (absolute and percent change)
    2.3) SBP at Week 16 in the subset of patients with Baseline SBP ≥130 mmHg
    2.4) Bolus insulin dose at Week 24 (as an average over the 3-5 days prior to the visit).
    Da misurare quale variazione dal basale in sotagliflozin 400 mg rispetto al placebo per ciascuno dei seguenti:
    2.1) A1C alla Settimana 24
    2.2) Peso corporeo alla Settimana 24 (variazione assoluta e percentuale)
    2.3) PAS alla Settimana 16 nel sottoinsieme di pazienti con PAS Basale ≥130 mmHg
    2.4) Dose del bolo di insulina alla Settimana 24 (come media sui 3-5 giorni precedenti alla visita).
    E.5.2.1Timepoint(s) of evaluation of this end point
    2.1) At Week 24
    2.2) At Week 24
    2.3) At Week 16
    2.4) At Week 24
    2.1) Alla Settimana 24
    2.2) Alla Settimana 24
    2.3) Alla Settimana 16
    2.4) 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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    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 months0
    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 months5
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1050
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 575
    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)
    T1DM patients are treated with insulin during the trial and will continue on insulin after the end of trial.
    I pazienti con T1DM sono trattati con insulina durante lo studio e continueranno con l’insulina dopo la fine dello 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 Decision2015-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-20
    P. End of Trial
    P.End of Trial StatusCompleted
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