A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Recent Onset type1 Diabetes

In brief

Objectives The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve β-cell function and delay the progression of T1D in adolescent and adult patients. The safety of ladarixin in the specific clinical setting will be also evaluated.

Key facts

Study ID

NCT04628481

Run by

Dompé Farmaceutici S.p.A

People needed

141

Starts

2021-01-12

Expected to finish

2025-10-21

Last updated by the study team

2025-12-17

Who can join

Age: 14 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients aged 14-45 years, inclusive;
• Recent onset T1D (1st IMP dose within 180 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 one or more separate subcutaneous injections or Continuous Subcutaneous Insulin Infusion (CSII).
• Fasting C peptide < 0.205nmol/L;
• 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;
• 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 (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.

You may not qualify if…

• A type 2 diabetes diagnosis or any other unstable chronic disease for which dose adjustment of specific medication is anticipated during the trial;
• 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;
• 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;
• Occurrence of an episode of ketoacidosis or hypoglycemic coma in the past 2 weeks;
• A history of significant cardiovascular disease/abnormality;
• Known hypersensitivity to non-steroidal anti-inflammatory drugs;
• 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)];
• 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.);
• 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;
• 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);
• History of positive status for hepatitis A (IgM), hepatitis B (not due to immunization), hepatitis C 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); abstinence.

Where it is running

• 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
• University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Multidisciplinary Comprehensive Diabetes Clinic (MCDC) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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