140 Participants Needed

Ladarixin for Type 1 Diabetes

Recruiting at 55 trial locations
AM
FM
MD
MM
EM
Overseen ByEnrico Minnella, MD
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Ladarixin is unique because it targets and inhibits the CXCR1 and CXCR2 chemokine receptors, which are involved in inflammation, aiming to preserve the function of insulin-producing beta cells in newly diagnosed type 1 diabetes patients.12345

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?

EM

Enrico Minnella, MD

Principal Investigator

Dompé Farmaceutici

AM

Annarita Maurizi, MD

Principal Investigator

Dompé Farmaceutici

FS

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

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
You have specific antibodies related to diabetes.
My body still produces some insulin.
See 5 more

Exclusion Criteria

You are allergic to non-steroidal anti-inflammatory drugs.
I have a history of serious heart disease.
My liver tests show high enzyme levels and bilirubin.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral ladarixin or placebo for 13 cycles of 14 days on/14 days off over a 12-month period

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Open-label extension

Participants continue to be monitored under open-label conditions up to month 24

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Ladarixin
Trial Overview The study tests if Ladarixin can preserve the pancreas's beta-cell function in type 1 diabetics better than a placebo. It also looks at how safe Ladarixin is for patients. The participants will either receive the actual medication or a placebo without knowing which one they're getting.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LadarixinExperimental Treatment1 Intervention
400 mg b.i.d. for 13 cycles of 14 days on/14 days off
Group II: PlaceboPlacebo Group1 Intervention
matching placebo b.i.d. for 13 cycles of 14 days on/14 days off

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dompé Farmaceutici S.p.A

Lead Sponsor

Trials
53
Recruited
4,400+
Founded
:[-1880s implied start, exact date not specified],

Published Research Related to This Trial

In a study involving 76 adults with newly diagnosed type 1 diabetes, ladarixin (LDX) treatment did not significantly preserve C-peptide production, which is an indicator of beta cell function, compared to placebo after 13 weeks.
However, at week 26, a higher proportion of patients in the LDX group achieved an HbA1c level of less than 7.0% without experiencing severe hypoglycemic events, suggesting a transient metabolic benefit for some patients.
Ladarixin, an inhibitor of the interleukin-8 receptors CXCR1 and CXCR2, in new-onset type 1 diabetes: A multicentre, randomized, double-blind, placebo-controlled trial.Piemonti, L., Keymeulen, B., Gillard, P., et al.[2022]

Citations

Ladarixin, an inhibitor of the interleukin-8 receptors CXCR1 and CXCR2, in new-onset type 1 diabetes: A multicentre, randomized, double-blind, placebo-controlled trial. [2022]
Post hoc analysis of a randomized, double-blind, prospective trial evaluating a CXCR1/2 inhibitor in new-onset type 1 diabetes: endo-metabolic features at baseline identify a subgroup of responders. [2023]
Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study. [2022]
Benefit or Risk in Patient with Type 1 Diabetes Based on Appropriated Dosage of Dapagliflozin: A Case Report. [2023]
Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study. [2022]
Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with type 2 diabetes. [2022]
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