Ladarixin for Type 1 Diabetes

Not currently recruiting at 59 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new treatment called ladarixin can help people with type 1 diabetes (T1D) by protecting their insulin-producing cells and slowing the disease's progression. The trial also aims to ensure ladarixin's safety in this context. Participants will receive either ladarixin or a placebo (a substance with no active drug) to compare results. The trial seeks individuals aged 14-45 who have been diagnosed with type 1 diabetes within the last six months and require insulin therapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that ladarixin is likely to be safe for humans?

Research has shown that ladarixin has been tested in people with type 1 diabetes. The results indicated that most participants tolerated the treatment well, and no major safety issues emerged. However, the treatment remains under study, so researchers continue to monitor its safety. For those considering joining a trial, these early results suggest that ladarixin might be safe, but further research will provide a clearer picture. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 1 Diabetes?

Ladarixin is unique because it targets the inflammatory process in Type 1 Diabetes, which is different from standard treatments like insulin therapy. While insulin regulates blood sugar, Ladarixin works by blocking Interleukin-8 receptors, potentially reducing the immune attack on insulin-producing cells. This novel approach could preserve more of the body's natural insulin production, offering a new avenue for managing the disease. Researchers are excited because this could lead to better long-term outcomes for patients by slowing disease progression.

What evidence suggests that ladarixin might be an effective treatment for Type 1 Diabetes?

Research shows that ladarixin blocks certain signals in the body, specifically targeting interleukin-8 receptors. This action aims to protect the pancreatic cells that produce insulin in people with type 1 diabetes. However, earlier studies found that short-term use of ladarixin did not significantly preserve the function of these insulin-producing cells. These results suggest that while the mechanism of the treatment is understood, its actual effectiveness in slowing diabetes remains unclear. This trial will compare ladarixin with a placebo to further investigate its potential benefits for type 1 diabetes. More research is needed to determine its efficacy for this condition. ^{1 3 4 6 7}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT04628481

A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes ... Objectives The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve β-cell function and delay the progression ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05035368

Ladarixin as Adjunctive Therapy to Improve Insulin ... Objectives Primary study objective: To determine whether orally-administered ladarixin versus placebo adjunctive therapy improves insulin sensitivity in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35589610/

Ladarixin, an inhibitor of the interleukin-8 receptors CXCR1 ... Conclusions: In newly diagnosed patients with type 1 diabetes, short-term LDX treatment had no appreciable effect on preserving residual beta cell function.

4. clinicaltrial.be clinicaltrial.be/en/details/50732?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes... This is a phase 3, multicenter, double-blind, placebo-controlled study. It has been designed to further evaluate whether ladarixin is effective ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9540558/

Ladarixin, an inhibitor of the interleukin‐8 receptors ... In newly diagnosed patients with type 1 diabetes, short‐term LDX treatment had no appreciable effect on preserving residual beta cell function.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04899271?intr=NCT04899271&rank=1

A Study to Assess Efficacy/Safety of Ladarixin in Type 1 ... The objective of this clinical trial was to assess whether ladarixin treatment is effective to improve glycemic control in newly diagnosed Type 1 Diabetes ...

7. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05368402/

Trial | NCT05368402 Primary objective \- To determine whether oral ladarixin versus placebo adjunctive therapy improves glycemic control in overweight, insulin resistant (IR) ...