A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline.

Stopped early · Phase 2 · Has a placebo group

Conditions studied: New-onset Type 1 Diabetes

In brief

The objective of this clinical trial was to assess whether ladarixin treatment is effective to improve glycemic control in newly diagnosed Type 1 Diabetes (T1D) adult patients with preserved β-cell function. The safety of ladarixin in the specific clinical setting was also evaluated.

Key facts

Study ID: NCT04899271
Run by: Dompé Farmaceutici S.p.A
People needed: 25
Starts: 2020-12-14
Expected to finish: 2023-10-11
Last updated by the study team: 2025-05-14

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female patients aged 18-45 years, inclusive;
New-onset T1D (1st IMP dose within 100 days from 1st insulin administration);
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);
Require, or has required at some time, insulin therapy through multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII);
Fasting C peptide ≥0.205nmol/L on two occasions;
Patient able to comply with all protocol procedures for the duration of the study, including scheduled follow-up visits and examinations;
Patients who have given written informed consent prior of any study-related procedure not part of standard medical care.

You may not qualify if…

Any other chronic disease, including type 2 diabetes, apart from autoimmune hypothyroidism requiring thyroid hormone replacement only; patients with severe (myxedema) disease potentially requiring immunosuppressive therapy will be excluded;
Moderate to severe renal impairment as per estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73 m2, as determined using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (see Appendix 14.4.3);
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];
Hypoalbuminemia defined as serum albumin < 3 g/dL;
QTcF > 470 msec;
A history of significant cardiovascular disease/abnormality
Occurrence of an episode of ketoacidosis or hypoglycemic coma in the past 2 weeks;
Known hypersensitivity to non-steroidal anti-inflammatory drugs;
Concomitant treatment with drugs metabolized by CYP2C9 with a narrow therapeutic index [i.e., phenytoin, warfarin, sulphanylurea hypoglycemics (e.g. tolbutamide, glipizide, glibenclamide/glyburide, glimepiride, nateglinide) and high dose of amitriptyline (>50 mg/day)];
Previous (within 2 weeks prior to randomization) 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.);
Past (within 1 month prior to randomization) or current administration of any immunosuppressive medications (including oral, inhaled or systemically injected steroids) and use of any investigational agents, including any agents that impact the immune response or the cytokine system;
Significant systemic infection during the 4 weeks before the first 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);
Hepatitis A (IgM), hepatitis B (not due to immunization), hepatitis C and HIV positive serologic status Serologic evidence of current infectious liver disease (hepatitis A, B, or C), including anti hepatitis A virus (immunoglobulin M), hepatitis B surface antigen, or anti hepatitis C virus and HIV;
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).

Where it is running

University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC) - Specialty Clinic — Aurora, Colorado, United States
Atlanta Diabetes Associates (ADA) — Atlanta, Georgia, United States
Universitair Ziekenhuis Brussel (UZB) — Jette, Belgium
National Center for Diabetes Research LTD — Tbilisi, Georgia
National Institute of Endocrinology LTD — Tbilisi, Georgia
Universitaetsklinikum Gessen und Marburg GmbH - Medizinische Klinik und Poliklinik III — Glessen, Germany
St. Josefskrankenhaus Diabestesinstitut Heidelberg — Heidelberg, Germany
Institut fuer Diabetes forschung in Muenster (IDFM) — Münster, Germany
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 Sacco — Milan, Italy
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" — Palermo, Italy
Università Campus Bio-Medico di Roma (UCBM) — Roma, Italy
"Sapienza" Università di Roma- Azienda Ospedaliero Universitaria Policlinico Umberto I — Rome, Italy
University of Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases — Belgrade, Serbia
University of Kragujevac, Clinic for internal diseases, Center for endocrinology, diabetes and metabolic diseases — Kragujevac, Serbia

Full record on ClinicalTrials.gov

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