Summary

Eligibility
for people ages 14-45 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Jeremy Pettus, MD
Headshot of Jeremy Pettus
Jeremy Pettus

Description

Summary

The objective of this clinical trial is to assess whether ladarixin treatment is effective in preserving beta-cell function and delaying the progression of type 1 diabetes (T1D) in adolescent and adult patients. The safety of ladarixin in the specific clinical setting will be also evaluated.

Official Title

Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy - Safety of 400 mg Twice a Day Oral Ladarixin in Pts With Recent Onset Type 1 Diabetes and Low Residual β-cell Function at Baseline (GLADIATOR STUDY)

Details

This is a phase 3, multicenter, double-blind, placebo-controlled study. It has been designed to further evaluate whether ladarixin is effective in preserving beta-cell function and slowing-down the progression of T1D) in patients with a more severe disease presentation. The study is planned to be performed at about 40 study centers in EU, US and in other countries, if appropriated. At each study center, the Principal Investigator (PI) will be responsible for ensuring that the investigation is conducted according to the signed Investigator agreement, the protocol, GCP guidelines, and local regulations. The study is planned to involve -327 patients with new-onset T1D, to include about 200 adolescents (14-17 years). Patients will be randomly (2:1) assigned to receive either ladarixin treatment (400 mg b.i.d. for 13 cycles of 14 days on/14 days off - treatment group) or matched placebo (control group). The two groups will be balanced within centers.

Keywords

New-onset type1 Diabetes type1 diabetes Diabetes Mellitus Diabetes Mellitus, Type 1 Ladarixin

Eligibility

You can join if…

Open to people ages 14-45

  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.

You CAN'T join if...

  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 (see Appendix 14.4.3);
  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, sulphanylurea 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

  • University of California San Diego accepting new patients
    La Jolla California 92037-0990 United States
  • University of California San Diego not yet accepting patients
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Jeremy Pettus, MD
    Associate Professor Of Clinical, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 57 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dompé Farmaceutici S.p.A
ID
NCT04628481
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 327 study participants
Last Updated