Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Experimental drug aims to save Insulin-Making cells in newly diagnosed type 1 diabetes

NCT ID NCT04628481

Disease control Sponsor: Dompé Farmaceutici S.p.A Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This Phase 2 trial tested an oral drug called ladarixin in 141 people aged 14-45 recently diagnosed with type 1 diabetes. The goal was to see if ladarixin could preserve the body's ability to produce insulin by protecting beta cells. The study was terminated early, so while it may provide clues for future treatments, it does not offer a cure or immediate benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ladarixin (oral drug)
What this could lead to
If successful, ladarixin could help preserve insulin production in people newly diagnosed with type 1 diabetes, potentially slowing disease progression.
What could go wrong
This Phase 2 trial was terminated early, so results are limited. The drug may not work as hoped, and side effects are possible. It is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

289 people

The number who actually took part.

Started

Jan 2021

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female patients aged 14-45 years, inclusive; 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: 1. A type 2 diabetes diagnosis or any other unstable chronic disease for which dose adjustment of specific medication is anticipated during the trial; 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Recent onset TYPE1 diabetes are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recent onset TYPE1 diabetes

Contacts and locations

Locations

  • "Sapienza" Università di Roma- Azienda Ospedaliero Universitaria Policlinico Umberto I

    Rome, 00161, Italy

  • "WakeMed Physician Practices - Pediatric Endocrinology - WakeMed Raleigh Medical Park Location"

    Raleigh, North Carolina, 27610, United States

  • AdventHealth (Florida Hospital) - Diabetes Institute - Orlando

    Orlando, Florida, 32804, United States

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi, 48102, Georgia

  • Atlanta Diabetes Associates (ADA)

    Atlanta, Georgia, 30318, United States

  • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

    Palermo, 90127, Italy

  • Azienda Ospedaliero-Universitaria Conzorziale Policlinico di Bari

    Bari, 70124, Italy

  • Center of Excellence in Diabetes & Endocrinology (CEDE)

    Sacramento, California, 95821-2123, United States

  • Centro regionale di Diabetologia Pediatrica "G. Stoppoloni", Azienda Ospedaliera Universitaria "Luigi Vanvitelli"

    Naples, Italy

  • Christiana Care Endocrinology Specialists

    Newark, Delaware, 19713, United States

  • Clinical Center Nis, Clinic for endocrinology

    Niš, 18000, Serbia

  • Clinical Center Nis, Clinic for endocrinology

    Niš, Serbia

  • Clinical Center of Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases

    Belgrade, 11000, Serbia

  • Clinical center Kragujevac, Clinic for internal diseases, Center for endocrinology, diabetes and metabolic diseases

    Kragujevac, 34000, Serbia

  • Clinique du Sud Luxembourg - Vivialia-Arlon

    Arlon, Belgium

  • Cook Children's Endocrinology and Diabetes Program

    Fort Worth, Texas, 76104, United States

  • Diabestesinstitut Heidelberg

    Heidelberg, Germany

  • Diabetes Care Center - Hudson

    Hudson, Florida, 34667-7151, United States

  • Die Praxis am Ludwigsplatz

    Ludwigshafen am Rhein, Germany

  • Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center

    Norfolk, Virginia, 23510, United States

  • General Hospital AZ Nikolaas

    Sint-Niklaas, Belgium

  • Global Life Research Network

    Miami, Florida, 33155, United States

  • Indiana University - Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Institut fuer Diabetes forschung in Muenster (IDFM)

    Münster, Germany

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Pediatrico Bambino Gesu

    Roma, Italy

  • Joslin Diabetes Center, Harvard Medical School

    Boston, Massachusetts, 02215, United States

  • Medical Center - University of Freiburg

    Freiburg im Breisgau, Germany

  • National Center for Diabetes Research LTD

    Tbilisi, 48159, Georgia

  • National Institute of Endocrinology LTD

    Tbilisi, 48159, Georgia

  • Ospedale Pediatrico G. Salesi - Centro Regionale di Diabetologia Clinica Pediatrica

    Ancona, 60123, Italy

  • Phoenician Centers for Research and Innovation

    Phoenix, Arizona, 85021, United States

  • Prairie Education and Research Cooperative d/b/a Central Illinois Diabetes and Clinical

    Springfield, Illinois, 62711, United States

  • Schneider Children's Medical Center, Petah Tikva

    Petah Tikva, 4920235, Israel

  • Schwerpunktpraxis fuer Diabetes & Ernaehrungsmedizin

    Münster, Germany

  • Soroka Medical Center

    Beersheba, Israel

  • Tbilisi Heart and Vascular Clinic LTD

    Tbilisi, 48159, Georgia

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Israel

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Cotton-O'Neil Diabetes and Endocrinology Center

    Topeka, Kansas, 66606-28, United States

  • The University of Chicago

    Chicago, Illinois, 60637, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UBMD Physicians Group - Pediatrics - Conventus

    Buffalo, New York, 14203, United States

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Universita Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli"

    Roma, Italy

  • Universitaetsklinikum Gessen und Marburg GmbH - Medizinische Klinik und Poliklinik III

    Glessen, 35392, Germany

  • Universitair Ziekenhuis Brussel (UZB)

    Jette, Belgium

  • University Children's Hospital

    Belgrade, Serbia

  • University Children's Hospital, University Medical Center Ljubljana

    Ljubljana, Slovenia

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

    Birmingham, Alabama, 35294, United States

  • University of California San Diego

    La Jolla, California, 92093, United States

  • University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC) - Specialty Clinic

    Aurora, Colorado, 80045, United States

  • University of Louisville

    Louisville, Kentucky, 40292, United States

  • University of Pennsylvania Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh - UPMC

    Pittsburgh, Pennsylvania, 15261, United States

  • Università Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario

    Roma, 00128, Italy

  • Università degli Studi Magna Graecia di Catanzaro, Azienda Ospedaliero-Universitaria Mater Domini

    Catanzaro, Italy

  • Universitá degli Studi di Milano - Ospedale Luigi Saco

    Milan, 20157, Italy