New-onset Type 1 Diabetes MedDRA version: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Ladarixin
Product Code: [DF2156A]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ladarixin
Current Sponsor code: DF 2156A
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
DOMPé FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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) 3 x upper limit of normal and increased total bilirubin >3 mg/dL [>51.3 µmol/L]); hypoalbuminemia (serum albumin 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this clinical trial is to evaluate whether a 12 month treatment with ladarixin is effective to improve glycemic control in newly diagnosed T1D adult patients with preserved ß-cell function.;Secondary Objective: The safety of ladarixin in the specific clinical setting will be evaluated;Primary end point(s): Proportion of patients with HbA1c <7% and daily insulin requirement <0.50 IU/Kg/day;Timepoint(s) of evaluation of this end point: Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with HbA1c 0.5% from baseline and daily insulin requirement <0.50 IU/Kg; 2-hour AUC of C-peptide response to the MMTT; Time in range (TIR) by Continuous Glucose Monitoring (CGM); HbA1c levels; Proportion of patients with HbA1c < 7% who did not experience severe hypoglycemic events during treatment; Additional Glucose Variability Indices derived from CGM (glucose AUC outside the target range of 70 – 180 mg/dL, 2-hour postprandial glucose (PPG), Mean Amplitude Glycemic Excursions (MAGE), continuous overall net glycemic action (CONGA)-n, Mean Of the Daily Differences (MODD), and mean daily blood glucose, SD (Standard Deviation).; Number of self-reported episodes of severe hypoglycemia; Average (previous 3 days) daily insulin requirements (IU/kg/day); Estimated Glucose Disposal Rate (eGDR);Timepoint(s) of evaluation of this end point: Month 6 and 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18 | — |
Countries
Belgium, Germany, Italy, United States
Contacts
Public ContactMarta Marelli
Dompè farmaceutici S.P.A.
Outcome results
None listed