Ladarixin for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing ladarixin, a medication that may help protect insulin-producing cells in the pancreas. It targets adolescents and adults who have been diagnosed with type 1 diabetes, especially those with severe cases. The goal is to see if ladarixin can slow down the progression of the disease and keep these cells working longer.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, including some antidiabetic agents, drugs metabolized by CYP2C9 with a narrow therapeutic index, and any immunosuppressive medications. If you are on these medications, you may need to stop them before participating.
What makes the drug Ladarixin unique for treating type 1 diabetes?
What data supports the effectiveness of the drug Ladarixin for type 1 diabetes?
The research indicates that Ladarixin, which targets specific receptors involved in inflammation, did not show a benefit in preserving insulin-producing cells in people newly diagnosed with type 1 diabetes. However, a subgroup analysis suggested that some patients with certain baseline characteristics might respond better to the treatment.12346
Who Is on the Research Team?
Enrico Minnella, MD
Principal Investigator
Dompé Farmaceutici
Annarita Maurizi, MD
Principal Investigator
Dompé Farmaceutici
Francesco Sergio, MD
Principal Investigator
Dompé Farmaceutici
Are You a Good Fit for This Trial?
This trial is for adolescents and adults aged 14-45 with recent onset type 1 diabetes who are insulin-dependent. Participants must have some remaining beta-cell function, not be pregnant or breastfeeding, willing to use contraception, and free from significant cardiovascular disease, renal impairment, certain drug treatments (like CYP2C9 metabolized drugs), and immune system conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either oral ladarixin or placebo for 13 cycles of 14 days on/14 days off over a 12-month period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to be monitored under open-label conditions up to month 24
What Are the Treatments Tested in This Trial?
Interventions
- Ladarixin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dompé Farmaceutici S.p.A
Lead Sponsor