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הניסוי הקליני NCT04628481 עבור Recent Onset type1 Diabetes הוא הופסק. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function שלב II 141 מתבגרים
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
ניסוי קליני NCT04628481 מתקיים כדי לבדוק את טיפול עבור Recent Onset type1 Diabetes. זהו מחקר שלב II מסוג התערבותי שנמצא כעת במצב הופסק. המחקר התחיל ב-12 בינואר 2021 ומתוכנן לכלול 141 משתתפים. המחקר מנוהל על ידי Dompé Farmaceutici S.p.A וצפוי להסתיים ב-21 באוקטובר 2025. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-17 בדצמבר 2025.
סיכום קצר
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.
תיאור מפורט
The study will be a phase 2, multicenter, double-blind, placebo-controlled study. It will randomize approximately 130-140 patients (with up to an estimated 15-20% adolescents), with recent onset (within 180 days from 1st insulin administration) type 1 diabetes (T1D), assigned (2:1) to receive either oral ladarixin treatment (400 mg b.i.d. for 13 cycles of 14 days on/14 days off - treatment group) or placebo (control ...הצג עוד
כותרת רשמית
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)
מצבים רפואיים
Recent Onset type1 Diabetesמזהי מחקר נוספים
- LDX0319
- 2020-001926-71 (מספר EudraCT)
מספר NCT
תחילת המחקר (בפועל)
2021-01-12
עדכון אחרון שפורסם
2025-12-17
סיום המחקר (מוערך)
2025-10-21
משתתפים (מתוכנן)
141
סוג המחקר
התערבותי
שלב
שלב II
סטטוס
הופסק
מילות מפתח
type1 diabetes
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
מרובע
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיLadarixin 400 mg b.i.d. for 13 cycles of 14 days on/14 days off | Ladarixin Oral ladarixin twice a day for 13 cycles |
פלצבו להשוואהPlacebo matching placebo b.i.d. for 13 cycles of 14 days on/14 days off | פלצבו Oral placebo twice a day for 13 cycles |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Change from baseline in 2-hour AUC of C-peptide response to the Mixed Model Tolerance Test (MMTT) | C-peptide level is an indirect measure of pancreatic beta-cell function. The MMTT was performed after an overnight fast, at baseline | Month 6 |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Change from baseline in 2-hour AUC of C-peptide response to the MMTT | Months 12, 18 and 24 | |
Change in HbA1c from baseline | Months 6, 12, 18 and 24 | |
Time in range (TIR) by Continuous Glucose Monitoring (CGM) | Months 6, 12, 18, 24 | |
Proportion of patients with HbA1c <7% who did not experience severe hypoglycemic events during treatment | Months 6, 12, 18, 24 | |
Average (previous 3 days) daily insulin requirement (IU/kg/day) | Months 6, 12, 18, 24 | |
Proportion of patients with HbA1c <7% and daily insulin requirement <0.5 (IU/kg/day) | Months 6, 12, 18, 24 | |
Additional Glucose Variability Indices derived from CGM | Additional Glucose Variability Indices derived from CGM (glucose AUC outside the target range of 70 - 180 mg/dL, 2-hour postprandial glucose (PPG)). | Months 6, 12, 18 and 24 |
Additional Glucose Variability Indices derived from MAGE | Additional Glucose Variability Indices derived from Mean Amplitude Glycemic Excursions (MAGE) | Months 6, 12, 18 and 24 |
Additional Glucose Variability Indices derived from CONGA-n | Additional Glucose Variability Indices derived from continuous overall net glycemic action (CONGA)-n | Months 6, 12, 18 and 24 |
Additional Glucose Variability Indices derived from MODD | Additional Glucose Variability Indices derived from Mean Of the Daily Differences (MODD). | Months 6, 12, 18 and 24 |
Additional Glucose Variability Indices derived from mean daily blood glucose, SD | Additional Glucose Variability Indices derived from mean daily blood glucose, SD (Standard Deviation). | Months 6, 12, 18 and 24 |
Number of self-reported episodes of severe hypoglycemia | For the purpose of this study, a severe hypoglycemic event is defined as an event with one of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level \<54mg/dL or prompt recovery after oral carbohydrate, i.e. glucose, or glucagon administration. | Months 6, 12, 18, 24 |
Percentage of patients not requiring insulin therapy | This outcome aims to assess the % of patients who do not require an insulin therapy | Months 6, 12, 18, 24 |
Estimated Glucose Disposal Rate (eGDR) | Estimated Glucose Disposal Rate (eGDR) is a marker for the Assessment of Insulin Resistance and a validated clinical tool for estimating insulin sensitivity in type 1 diabetes. | Months 6, 12, 18, 24 |
קריטריוני זכאות
גילאים מוערכים למחקר
ילד, מבוגר
גיל מינימלי למחקר
14 Years
מגדרים מוערכים למחקר
הכל
- 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.
- 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.
Dompé Farmaceutici S.p.Aאין נתוני קשר.
57 מיקומי המחקר ב-8 מדינות
Soroka Medical Center, Beersheba, Israel
Schneider Children's Medical Center, Petah Tikva, Petah Tikva, 4920235, Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
Alabama
University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Multidisciplinary Comprehensive Diabetes Clinic (MCDC), Birmingham, Alabama, 35294, United States
Arizona
Phoenician Centers for Research and Innovation, Phoenix, Arizona, 85021, United States
California
University of California San Diego, La Jolla, California, 92093, United States
Center of Excellence in Diabetes & Endocrinology (CEDE), Sacramento, California, 95821-2123, United States
Colorado
University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC) - Specialty Clinic, Aurora, Colorado, 80045, United States
Delaware
Christiana Care Endocrinology Specialists, Newark, Delaware, 19713, United States
Florida
Diabetes Care Center - Hudson, Hudson, Florida, 34667-7151, United States
Global Life Research Network, Miami, Florida, 33155, United States
AdventHealth (Florida Hospital) - Diabetes Institute - Orlando, Orlando, Florida, 32804, United States
Georgia
Atlanta Diabetes Associates (ADA), Atlanta, Georgia, 30318, United States
Illinois
The University of Chicago, Chicago, Illinois, 60637, United States
Prairie Education and Research Cooperative d/b/a Central Illinois Diabetes and Clinical, Springfield, Illinois, 62711, United States
Indiana
Indiana University - Riley Hospital for Children, Indianapolis, Indiana, 46202, United States
Kansas
The Cotton-O'Neil Diabetes and Endocrinology Center, Topeka, Kansas, 66606-28, United States
Kentucky
University of Louisville, Louisville, Kentucky, 40292, United States
Massachusetts
Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, 02215, United States
New York
UBMD Physicians Group - Pediatrics - Conventus, Buffalo, New York, 14203, United States
North Carolina
"WakeMed Physician Practices - Pediatric Endocrinology - WakeMed Raleigh Medical Park Location", Raleigh, North Carolina, 27610, United States
Pennsylvania
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States
UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh - UPMC, Pittsburgh, Pennsylvania, 15261, United States
Texas
Cook Children's Endocrinology and Diabetes Program, Fort Worth, Texas, 76104, United States
Texas Children's Hospital, Houston, Texas, 77030, United States
Virginia
Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center, Norfolk, Virginia, 23510, 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, 48102, Georgia
National Center for Diabetes Research LTD, Tbilisi, 48159, Georgia
National Institute of Endocrinology LTD, Tbilisi, 48159, Georgia
Tbilisi Heart and Vascular Clinic LTD, Tbilisi, 48159, Georgia
Medical Center - University of Freiburg, Freiburg im Breisgau, Germany
Universitaetsklinikum Gessen und Marburg GmbH - Medizinische Klinik und Poliklinik III, Glessen, 35392, 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
Ospedale Pediatrico G. Salesi - Centro Regionale di Diabetologia Clinica Pediatrica, Ancona, 60123, Italy
Azienda Ospedaliero-Universitaria Conzorziale Policlinico di Bari, Bari, 70124, 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
Centro regionale di Diabetologia Pediatrica "G. Stoppoloni", Azienda Ospedaliera Universitaria "Luigi Vanvitelli", Naples, Italy
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy
Università Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario, Roma, 00128, 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, 00161, Italy
Clinical Center of Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases, Belgrade, 11000, Serbia
University Children's Hospital, Belgrade, Serbia
Clinical center Kragujevac, Clinic for internal diseases, Center for endocrinology, diabetes and metabolic diseases, Kragujevac, 34000, Serbia
Clinical Center Nis, Clinic for endocrinology, Niš, 18000, Serbia
Clinical Center Nis, Clinic for endocrinology, Niš, Serbia
University Children's Hospital, University Medical Center Ljubljana, Ljubljana, Slovenia