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    Summary
    EudraCT Number:2022-000743-68
    Sponsor's Protocol Code Number:LDX0122
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-05-12
    Trial 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 number2022-000743-68
    A.3Full title of the trial
    A phase II randomized, placebo-controlled, double-blinded, 2-parallel arm, clinical trial evaluating Ladarixin 400 mg twice a day as adjunctive therapy to improve glycemic control in overweight insulin-resistant patients with type 1 diabetes.
    Studio di Fase II randomizzato, verso placebo, controllato in doppio cieco, a due braccia parallele, volto a valutare ladarixin 400 mg somministrato due volte al giorno, come terapia aggiuntiva per migliorare il controllo glicemico in pazienti con diabete di tipo 1, sovrappeso ed insulino-resistenti.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to evaluate Ladarixin as an additional therapy to improve glycemic control in overweight insulin resistance patients with type 1 diabetes.
    Studio clinico con ladarixin come terapia aggiuntiva per migliorare il controllo glicemico in pazienti con diabete di tipo 1, sovrappeso ed insulino-resistenti
    A.3.2Name or abbreviated title of the trial where available
    N/A
    N/A
    A.4.1Sponsor's protocol code numberLDX0122
    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 SponsorDOMPé FARMACEUTICI S.P.A.
    B.1.3.4CountryItaly
    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 supportDompé farmaceutici S.P.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompé farmaceutici S.P.A.
    B.5.2Functional name of contact pointMarta Marelli
    B.5.3 Address:
    B.5.3.1Street AddressVia Santa Lucia 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number3427323518
    B.5.6E-mailmarta.marelli@dompe.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 nameLadarixin
    D.3.2Product code [DF2156A]
    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 INNLadarixin
    D.3.9.2Current sponsor codeDF2156A
    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 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
    overweight insulin-resistant patients with type 1 diabetes
    Pazienti con diabete tipo 1, sovrappeso ed insulino-resistenti
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes
    diabete di tipo 1
    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 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
    The primary objective of this clinical trial is to determine whether oral ladarixin is efficacious in improving glycemic control in overweight, insulin-resistant adult subjects with type 1 diabetes.
    Obiettivo primario di questo studio clinico è determinare se il trattamento con ladarixin somministrato per via orale è efficace nel migliorare il controllo glicemico in pazienti adulti con diabete di tipo 1, sovrappeso ed insulino-resistenti.
    E.2.2Secondary objectives of the trial
    To ascertain the effect of ladarixin on glycemic variability as per CGM derived parameters.
    To determine the safety of oral ladarixin versus placebo adjunctive therapy in overweight, Insulin resistant adult subjects with Type 1 Diabetes.
    Valutare l'effetto di ladarixin sulla variabilità glicemica derivata dalle misurazioni tramite dispositivo CGM.
    Confermare la sicurezza di ladarixin orale in confronto di placebo come una terapia aggiuntiva in pazienti con diabete di tipo 1, sovrappeso ed insulino-resistenti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients of both sex aged 21-65 years inclusive, with clinical diagnosis of Type 1 Diabetes for over 1 year and insulin resistance; the presence of at least one or more of Insulin autoantibodies: Anti-GAD;IAA; IA2; ZnT8); detectable fasting C-peptide = 0.02 nmol/L; either established use of an insulin pump or a stable dose level and dose frequency for the last two months; routine use of a self-owned Continuous Glucose Monitoring (CGM) system that can record glucose concentrations continuously for at least 7 days; HbA1c value >7.5%; subject is overweight or obese as per body mass index of between 24-33 kg/m2, inclusive.
    Saranno inclusi nello studio pazienti di età compresa tra 21 e 65 anni inclusi, di entrambi i sessi, con diagnosi di Tipo 1 diabete (più di un anno) e la resistenza di insulino che abbiano dato il proprio consenso informato. I pazienti devono essere positivi ad almeno uno degli autoanticorpi associati al diabete (anti-GAD; IAA; IA-2; ZnT8), devono assunto insulina somministrata tramite iniezioni multiple giornaliere (stabilizzato per due mesi) o tramite dispositivi di infusione sottocutanea continua di insulina; devono avere valori a digiuno di C-peptide = 0.02 nmol/L; deveono usare un monitorragio continuo del glucosio che registra oer al meno di 7 giorni; avere i valori di HbA1c >7.5%;avere un indice massa corporea di 24-33 kg/m2 inclusi.
    E.4Principal exclusion criteria
    Patients with known or suspected hypersensitivity to the active pharmaceutical ingredient, non-steroidal anti-inflammatory drugs or any excipient of the investigational medicinal product; who use a “closed loop system” for integrated glucose reading/insulin infusion; use of non-insulin medications for adjunctive blood glucose control (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors, SGLT-2 inhibitors or amylin) within one month of randomization; use of medications for weight reduction; use of a medication e.g. stimulants, antidepressants and/or psychotropic agents that could affect weight gain or glycemic control of T1D; treatment with drugs metabolized by CYP2C9 with a narrow therapeutic index e.g. phenytoin, warfarin, and high dose of amitriptyline (>50 mg/day); use of angiotensin-converting enzyme inhibitors, interferons, quinidine antimalarial drugs, lithium, niacin; evidence of QTcF >470 msec and a history of significant cardiovascular disease/abnormality; any condition, including unstable diet and disordered eating behaviour, that in the judgment of the investigator will adversely affect patient’s safety or the completion of the protocol or otherwise confound study outcome; pregnancy; clinical diagnosis of celiac disease that is in poor control as defined by most recent tissue transglutaminase (tTG) that is in the abnormal range; history of Diabetic Ketoacidosis (DKA) events in the past 6 months; hypoalbuminemia (serum albumin <3 g/dL); hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 µmol/L]; moderate to severe renal impairment; past or current administration of any immunosuppressive medications and use of any investigational agents, including any agents that impact the immune response; a condition already known which interferes with the ability to accurately determine glycated HbA1c; significant systemic infection during the 4 weeks before the 1st dose of study drug.
    Saranno esclusi i pazienti con nota o sospetta ipersensibilità al principo attivo, farmaci antiinfiammatori non steroidei o ad uno qualsiasi degli eccipiente; chi usa un sistema a circuito chiuso per l'infusione e misura di insulina; pazienti che assumono, o
    hanno assunto nelle 1 mese precedente la randomizzazione, farmaci antidiabetici
    come metformina, sulfaniluree, glinidi, tiazolidinedioni, exenatide, liraglutide,
    inibitori della dipeptidil-peptidasi IV (DPP-IV,) inibitori del co-trasportare sodio-glucosio (SGLT-2), o amilina, usa medicazione per ridotto il peso corporale; usa farmaci (stimulanti, antidepressivi e/o agenti psicotropi che potrebbero influenzare l'aumento di peso o il controllo glicemico del T1D; terapia con farmaci metabolizzati dal citocromo CYP2C9 con un basso indice terapeutico (per es. fenitoina, warfarina, sulfaniluree
    ipoglicemizzanti e alti dosaggi di amitriptilina (> 50 mg/die); uso di inibitori dell'enzima di conversione dell'angiotensina, interferoni, farmaci antimalarici a base di quinidina, litio, niacina; con QTcF >470 msec; con una storia di patologie/anomalie cardiovascolari clinicamente significative; La presenza di una dieta instabile, un comportamento alimentare disordinato, o qualsiasi condizione che lo sperimentatore giudica avrà un impatto negativo sulla sicurezza del paziente o integrità del protocollo; gravidanza; diagnosi clinica della malattia celiaca che è in scarso controllo come definita dalla più recente transglutaminasi tissutale (tTG) che è nel range anormale; pazienti che hanno
    manifestato un episodio di chetoacidosi o coma ipoglicemico nei 6 mesi precedenti; con ipoalbuminemia (albumina sierica <3 g/dl); con disfunzione epatica (ALT/AST superiori di tre volte il limite superiore di normalità e bilirubina totale > 3 mg/dL [>51,3 µmol/L]; insufficienza renale moderata o severa; qualsiasi farmaco immunosoppressivo o altre molecule in sperimentazione, incluse quelle che influenzano la risposta immunitaria; una condizione che interferisce con la capacità di determinare con precisione l'HbA1c glicata; significativa infezione sistemica durante le 4 settimane precedenti della prima dose di farmaco sperimentale.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with an HbA1c reduction from baseline of >=0.50% without episodes of severe hypoglycemia
    Proporzione di pazienti con una riduzione dei valori di HbA1c >= 0.50% rispetto al basale e senza episodi di ipoglicemia severa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 27/28 (visit 4 at 6 months).
    settimana 27/28 (visita 4 a 6 mesi)
    E.5.2Secondary end point(s)
    The proportion of patients with an HbA1c reduction from baseline of >=0.50% without episodes of severe hypoglycemia; The mean difference from baseline in HbA1c assessed at week 11/12 (visit 3) and 27/28 (visit 4); Average (previous 3 days) daily insulin requirements (IU/kg/day) assessed at week 11/12 (visit 3) and 27/28 (visit 4); Glycemic Variability by CGM (previous 7 days): time in range (TIR), time above range (TAR) time below range (TBR), standard deviation and coefficient of variation
    Proporzione di pazienti con una riduzione dei valori di HbA1c >= 0.50% rispetto al basale e senza episodi di ipoglicemia severa.; Differenza media dal basale dei valori di HbA1c alla settimana 11/12 (visita 3) e alla settimana 27/28 (visita 4).; Fabbisogno insulinico giornaliero medio (nei 3 giorni precedenti) (IU/kg/giorno) valutato alla settimana 11/12 (visita 3) e alla settimana 27/28 (visita 4); Variabilità glicemica derivata dalle misurazioni tramite dispositivo CGM (nei precendenti 7 giorni): TIR, TBR, deviazione standard e coefficiente di variazione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 11/12 (visit 3); week 27/28 (visit 4); At week 11/12 (visit 3) and week 27/28 (visit 4); At week 11/12 (visit 3) and week 27/28 (visit 4).
    Settimana 11/12 (visita 3); settimana 27/28 (visita 4); settimana 11/12 (visita 3) e settimana 27/28 (visita 4); Settimana 11/12 (visita 3) e settimana 27/28 (visita 4)
    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 No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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
    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 years1
    E.8.9.1In the Member State concerned months1
    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 months1
    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: 81
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 86
    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)
    After completion of the week 27/28 (visit 4) follow-up visit, patients will receive poststudy care as prescribed by their health care provider. No post-study treatment will be provided by Dompé.
    Dopo il completamento della visita di follow-up alla settimana 27/28 (visit 4), i pazienti riceveranno cure post studio come prescritto dal loro medico curante. Nessun trattamento post-studio verra' fornito da Dompé.
    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 Decision2022-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-09-18
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