A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function
NCT ID: NCT04628481
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
141 participants
INTERVENTIONAL
2021-01-12
2025-10-21
Brief Summary
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The safety of ladarixin in the specific clinical setting will be also evaluated.
Detailed Description
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Ladarixin and placebo will be both administered for 1 year. All patients will be followed-up for 24 months from the 1st administration of the study medication. After the initial 12-m treatment period, all patients will enter into a 12-month follow-up (total period 24-month after first IMP administration). The study database (DB) will be locked when the last randomized patient has completed the month 12 visit (or being lost in follow-up), and relative data have been fully reconciled and cleaned; at that point, the DB will be unblinded and all endpoints, including the 6-month primary endpoint, will be analyzed, and the follow-up will continue under open-label conditions up to month 24.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ladarixin
400 mg b.i.d. for 13 cycles of 14 days on/14 days off
Ladarixin
Oral ladarixin twice a day for 13 cycles
Placebo
matching placebo b.i.d. for 13 cycles of 14 days on/14 days off
Placebo
Oral placebo twice a day for 13 cycles
Interventions
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Ladarixin
Oral ladarixin twice a day for 13 cycles
Placebo
Oral placebo twice a day for 13 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Recent onset T1D (1st IMP dose within 180 days from 1st insulin administration);
3. Positive for at least one diabetes-related auto-antibody (anti-GAD; IAA, if obtained within 10 days of the onset of insulin therapy; IA-2 antibody; ZnT8);
4. Require, or has required at some time, insulin therapy through one or more separate subcutaneous injections or Continuous Subcutaneous Insulin Infusion (CSII).
5. Fasting C peptide \< 0.205nmol/L;
6. Residual beta-cell function as per peak stimulated (MMTT) C-peptide level \>0.2nmol/L; MMTT should not be performed within one week of resolution of a diabetic ketoacidosis event;
7. Patient able to comply with all protocol procedures for the duration of the study, including scheduled follow-up visits and examinations;
8. Patients who have given written informed consent prior of any study-related procedure not part of standard medical care (participants under the age of 18, shall provide an assent for the study as per country requirements). Specific consent must be given by adolescents to be selected for the full PK analysis.
Exclusion Criteria
2. Moderate to severe renal impairment as per estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73m2, as determined using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation;
3. Hepatic dysfunction defined by increased ALT/AST \> 3 x upper limit of normal (ULN) and increased total bilirubin \> 3 mg/dL \[\>51.3 μmol/L\];
4. Hypoalbuminemia defined as serum albumin \< 3 g/dL;
5. QTcF \> 470 msec;
6. Occurrence of an episode of ketoacidosis or hypoglycemic coma in the past 2 weeks;
7. A history of significant cardiovascular disease/abnormality;
8. Known hypersensitivity to non-steroidal anti-inflammatory drugs;
9. Concomitant treatment with drugs metabolized by CYP2C9 with a narrow therapeutic index \[i.e. phenytoin, warfarin, sulphonylurea hypoglycemics (e.g. tolbutamide, glipizide, glibenclamide/glyburide, glimepiride, nateglinide) and high dose amitriptyline (\> 50 mg/day)\];
10. Previous (past 2 weeks) and concomitant treatment with antidiabetic agents as metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors, SGLT2-inhibitors or amylin, or any medications known to influence glucose tolerance (e.g. beta-blockers, angiotensin-converting enzyme inhibitors, interferons, quinidine antimalarial drugs, lithium, niacin, etc.);
11. Past (past month) or current administration of any immunosuppressive medications (including oral or systemic corticosteroids) and use of any investigational agents, including any agents that impact the immune response or the cytokine system;
12. Significant systemic infection during the 4 weeks before the 1st dose of the study drug (e.g., infection requiring hospitalization, major surgery, or IV antibiotics to resolve; other infections, e.g., bronchitis, sinusitis, localized cellulitis, candidiasis, or urinary tract infections, must be assessed on a case-by-case basis by the investigator regarding whether they are serious enough to warrant exclusion);
13. History of positive status for hepatitis A (IgM), hepatitis B (not due to immunization), hepatitis C and HIV..
14. Pregnant or breast-feeding women. Unwillingness to use effective contraceptive measures up to 2 months after the end of study drug administration (females and males). Effective contraceptive measures include a hormonal birth control (e.g. oral pills, long term injections, vaginal ring, patch); the intrauterine device (IUD); a double barrier method (e.g. condom or diaphragm plus spermicide foam); abstinence.
14 Years
45 Years
ALL
No
Sponsors
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Dompé Farmaceutici S.p.A
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Multidisciplinary Comprehensive Diabetes Clinic (MCDC)
Birmingham, Alabama, United States
Phoenician Centers for Research and Innovation
Phoenix, Arizona, United States
University of California San Diego
La Jolla, California, United States
Center of Excellence in Diabetes & Endocrinology (CEDE)
Sacramento, California, United States
University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC) - Specialty Clinic
Aurora, Colorado, United States
Christiana Care Endocrinology Specialists
Newark, Delaware, United States
Diabetes Care Center - Hudson
Hudson, Florida, United States
Global Life Research Network
Miami, Florida, United States
AdventHealth (Florida Hospital) - Diabetes Institute - Orlando
Orlando, Florida, United States
Atlanta Diabetes Associates (ADA)
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Prairie Education and Research Cooperative d/b/a Central Illinois Diabetes and Clinical
Springfield, Illinois, United States
Indiana University - Riley Hospital for Children
Indianapolis, Indiana, United States
The Cotton-O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Joslin Diabetes Center, Harvard Medical School
Boston, Massachusetts, United States
UBMD Physicians Group - Pediatrics - Conventus
Buffalo, New York, United States
"WakeMed Physician Practices - Pediatric Endocrinology - WakeMed Raleigh Medical Park Location"
Raleigh, North Carolina, United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Pittsburgh - UPMC
Pittsburgh, Pennsylvania, United States
Cook Children's Endocrinology and Diabetes Program
Fort Worth, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center
Norfolk, Virginia, United States
Clinique du Sud Luxembourg - Vivialia-Arlon
Arlon, , Belgium
Universitair Ziekenhuis Brussel (UZB)
Jette, , Belgium
General Hospital AZ Nikolaas
Sint-Niklaas, , Belgium
Aleksandre Aladashvili Clinic LLC
Tbilisi, , Georgia
National Center for Diabetes Research LTD
Tbilisi, , Georgia
National Institute of Endocrinology LTD
Tbilisi, , Georgia
Tbilisi Heart and Vascular Clinic LTD
Tbilisi, , Georgia
Medical Center - University of Freiburg
Freiburg im Breisgau, , Germany
Universitaetsklinikum Gessen und Marburg GmbH - Medizinische Klinik und Poliklinik III
Glessen, , Germany
Diabestesinstitut Heidelberg
Heidelberg, , Germany
Die Praxis am Ludwigsplatz
Ludwigshafen am Rhein, , Germany
Institut fuer Diabetes forschung in Muenster (IDFM)
Münster, , Germany
Schwerpunktpraxis fuer Diabetes & Ernaehrungsmedizin
Münster, , Germany
Soroka Medical Center
Beersheba, , Israel
Schneider Children's Medical Center, Petah Tikva
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Ospedale Pediatrico G. Salesi - Centro Regionale di Diabetologia Clinica Pediatrica
Ancona, , Italy
Azienda Ospedaliero-Universitaria Conzorziale Policlinico di Bari
Bari, , Italy
Università degli Studi Magna Graecia di Catanzaro, Azienda Ospedaliero-Universitaria Mater Domini
Catanzaro, , Italy
Universitá degli Studi di Milano - Ospedale Luigi Saco
Milan, , Italy
Centro regionale di Diabetologia Pediatrica "G. Stoppoloni", Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
Napoli, , Italy
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo, , Italy
Università Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario
Roma, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Pediatrico Bambino Gesu
Roma, , Italy
Universita Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli"
Roma, , Italy
"Sapienza" Università di Roma- Azienda Ospedaliero Universitaria Policlinico Umberto I
Rome, , Italy
Clinical Center of Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
Belgrade, , Serbia
University Children's Hospital
Belgrade, , Serbia
Clinical center Kragujevac, Clinic for internal diseases, Center for endocrinology, diabetes and metabolic diseases
Kragujevac, , Serbia
Clinical Center Nis, Clinic for endocrinology
Niš, , Serbia
Clinical Center Nis, Clinic for endocrinology
Niš, , Serbia
University Children's Hospital, University Medical Center Ljubljana
Ljubljana, , Slovenia
Countries
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Other Identifiers
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2020-001926-71
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LDX0319
Identifier Type: -
Identifier Source: org_study_id