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

Korábbi kezelés

• 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 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)
• 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 spermacide foam); abstinence.
• 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 of amitriptyline (>50 mg/day)]

Más betegség

• A type 2 diabetes diagnosis or any other unstable chronic disease for which dose adjustment of specific medication is anticipated during the trial
• History of positive status for hepatitis A (IgM), hepatitis B (not due to immunization), hepatitis C and HIV
• A history of significant cardiovascular disease/abnormality
• Known hypersensitivity to non-steroidal anti-inflammatory drugs

Laborértékek

• Previous (past 2 weeks) and concomitant treatment withantidiabetic 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.)
• 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

Egyéb

• QTcF > 470 msec
• Occurrence of an episode of ketoacidosis or hypoglycemic coma in the past 2 weeks

• 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 β-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.