Study to evaluate the the efficacy and the safety of ladaraxin in patients with new-onset type 1 diabetes

Phase 1

• Conditions: ew-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: EUCTR2020-002966-15-IT
• Lead Sponsor: DOMPé FARMACEUTICI S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-22
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Consented male and female patients aged 18-45 years, inclusive, with new-onset T1D (randomization scheduled to allow the administration of the study medication to start within 100 days from 1st insulin administration). Patients must be 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); must require, or have required insulin delivered via multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII); must have a fasting C-peptide =0.205 nmol/L on two occasions
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded if they have any other chronic disease (including type 2 diabetes), apart from patients with autoimmune hypothyroidism requiring thyroid hormone replacement only; 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. ß-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, inhaled or systemically injected steroids) 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 first 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); hepatitis A (IgM), hepatitis B (not due to immunization), hepatitis C and HIV positive serologic status. 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