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NCT04628481

PHASE2

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

Sponsor: Dompé Farmaceutici S.p.A

View on ClinicalTrials.gov

Summary

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.

Official title: Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess Effect and Safety of 400 mg Twice a Day Oral Ladarixin in Patients With Recent Onset Type 1 Diabetes and Low Residual β-cell Function at Baseline (GLADIATOR)

Key Details

Gender

All

Age Range

14 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

289

Start Date

2021-01-12

Completion Date

2025-10-21

Last Updated

2026-08-31

Healthy Volunteers

Conditions

Recent Onset type1 Diabetes

Interventions

DRUG

Ladarixin

Oral ladarixin twice a day for 13 cycles

DRUG

Placebo

Oral placebo twice a day for 13 cycles

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.

Locations (57)

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"

Naples, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (57)