Ladarixin for Type 1 Diabetes

Recruiting at 55 trial locations

Overseen By Enrico Minnella, MD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Dompé Farmaceutici S.p.A

Must not be taking: Antidiabetics, Immunosuppressives

Disqualifiers: Type 2 diabetes, Renal impairment, Hepatic dysfunction, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

140 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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

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.

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.

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?

Group I: Ladarixin Experimental Treatment 1 Intervention

400 mg b.i.d. for 13 cycles of 14 days on/14 days off

Group II: Placebo Placebo Group 1 Intervention

matching placebo b.i.d. for 13 cycles of 14 days on/14 days off

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. England pubmed.ncbi.nlm.nih.gov

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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Benefit or Risk in Patient with Type 1 Diabetes Based on Appropriated Dosage of Dapagliflozin: A Case Report. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with type 2 diabetes. [2022]