Study to evaluate the efficacy and the safety of ladaraxin in adult and adolescent patients with recent onset type 1 diabetes

Phase 1

Active, not recruiting

• Conditions: Recent onset Type 1 Diabetes; MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-001926-71-DE
• Lead Sponsor: Dompe farmaceutici s.p.a.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-14
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 327

Inclusion Criteria

Consented male and female patients aged 14-45 years, inclusive, with
recent onset T1D (randomization scheduled to allow the administration
of the study medication to start within 180 days from 1st insulin
administration). Patients must be positive for at least one diabetesrelated auto-antibody (anti-GAD; IAA, if obtained within 10 days of the
onset of insulin therapy; IA-2 antibody; ZnT8); must require, or have
required insulin delivered via one or more separate subcutaneous
injections or Continuous Subcutaneous Insulin Infusion (CSII); must
have a fasting C-peptide below 0.205 nmol/L, but must retain a Beta-cell
function as per peak stimulated (MMTT) C-peptide level >0.2 nmol/L.
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 127
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients will be excluded if they have a type 2 diabetes or any other
unstable chronic disease for which dose adjustment of specific
medication is anticipated during the trial; moderate to severe renal
impairment calculated by estimated Glomerular Filtration Rate (eGFR)
<60 mL/min/1.73 m2 as determined using Chronic Kidney Disease
Epidemiology Collaboration (CKD-EPI) creatinine equation; hepatic
dysfunction (increased ALT/AST >3 x upper limit of normal and
increased total bilirubin >3 mg/dL [>51.3 µmol/L]); hypoalbuminemia (serum albumin <3 g/dL); a QTcF > 470 msec.; a history of significant
cardiovascular disease/abnormality; occurrence of an episode of
ketoacidosis or hypoglycemic coma in the past 2 weeks; a known
hypersensitivity to non-steroidal anti-inflammatory drugs. Patients on
treatment with drugs metabolized by CYP2C9 with a narrow therapeutic
index [i.e. phenytoin, warfarin, sulphanylurea hypoglycemics and high
dose of amitriptyline (>50 mg/day)]; patients with past (within 2 weeks
prior to randomization) or current use of antidiabetic agents as
metformin, sulfonylureas, glinides, thiazolidinediones, exenatide,
liraglutide, DPP-IV inhibitors, SGLT-2 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.) will also be excluded. Patients
will be excluded as well in case of past (within 1 month prior to
randomization) 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. Additional exclusion criteria will be:
significant systemic infection during the 4 weeks before the 1st dose of
study drug (e.g., infection requiring hospitalization, major surgery, or
i.v. 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. Also, pregnant or breastfeeding women or patients unwilling to
use effective contraceptive measures (females and males) will be
excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified