What side effects are associated with this type of intervention?

The most common treatments for Type 1 Diabetes include insulin therapy and pramlintide. Insulin therapy can lead to hypoglycemia, weight gain, and injection site reactions. Pramlintide, used alongside insulin, may cause nausea, reduced mealtime insulin doses, and weight loss, but also carries a risk of severe hypoglycemic events. The trial of ladarixin, an IL-8 receptor antagonist, aims to preserve beta-cell function and delay T1D progression, but specific side effects in this context are not detailed.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes, primarily focusing on insulin therapy to manage blood glucose levels. Disease-modifying therapies and immunomodulatory treatments have been explored, such as the use of recombinant human GAD65 (GAD-alum) and abatacept (CTLA4-Ig), but these have not shown significant efficacy in clinical trials. Currently, there are no FDA-approved IL-8 receptor antagonists like Ladarixin for the treatment of T1D.

What other types of research exist?

A promising novel alternative to Ladarixin for Type 1 Diabetes patients is Sitagliptin, a DPP-4 inhibitor, which has shown potential in preserving beta-cell function in slowly progressive Type 1 Diabetes (SPIDDM). Ongoing research and clinical trials may also introduce new treatments by 2024.

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CXC Chemokine Receptor 1 (CXCR1) and CXCR2 Antagonist

Ladarixin for Type 1 Diabetes

Phase 2

Waitlist Available

Research Sponsored by Dompé Farmaceutici S.p.A

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Require, or has required at some time, insulin therapy through one or more separate subcutaneous injections or Continuous Subcutaneous Insulin Infusion (CSII)

Male and female patients aged 14-45 years, inclusive

Must not have

A history of significant cardiovascular disease/abnormality

Hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 μmol/L]

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 6, 12, 18, 24

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of Ladarixin aren't listed here, similar medications often cause issues like allergic reactions, liver problems indicated by increased enzymes in blood tests, digestive disturbances, potential kidney effects reflected in lab values (eGFR), and changes in heart rhythm (QTcF interval).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I use or have used insulin injections or a pump for my diabetes.

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I am between 14 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of serious heart disease.

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My liver tests show high enzyme levels and bilirubin.

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I am not taking medications like warfarin or certain diabetes drugs.

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My kidney function is moderately to severely reduced.

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I haven't taken any immunosuppressive drugs or experimental treatments in the past month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 6, 12, 18, 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 6, 12, 18, 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 6, 12, 18, 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in 2-hour AUC of C-peptide response to the Mixed Model Tolerance Test (MMTT)

Secondary study objectives

Additional Glucose Variability Indices derived from CGM

Additional Glucose Variability Indices derived from CONGA-n

Additional Glucose Variability Indices derived from MAGE

+5 more

Side effects data

From 2019 Phase 2 trial • 76 Patients • NCT02814838

28%

Headache

26%

Viral upper respiratory tract infection

12%

Dyspepsia

12%

Pyrexia

Hypoglycaemia

Oropharyngeal pain

Arthralgia

Abdominal pain upper

Nausea

Dizziness

Upper respiratory tract infection

Emotional distress

Insomnia

Tooth extraction

Constipation

Diarrhoea

Hyperchlorhydria

Vomiting

Oral herpes

Urinary tract infection

Aspartate aminotransferase increased

Dysmenorrhoea

Ear discomfort

Ear pain

abdominal discomfort

Drug hypersensitivity

Contusion

Fall

Joint injury

Ligament sprain

Muscle injury

Skin wound

Alanine aminotransferase increased

Glycosylated haemoglobin increased

Hyperglycaemia

mental disorder

Anaemia

Iron deficiency anaemia

Migrane

Syncope

Depression

Nipple inflammation

Asthma

Acne

Alopecia

Neutropenia

Abdominal pain

Eosinophilia

Dental caries

Gatroesophageal reflux disease

Folliculitis

Hypercholesterolaemia

Back pain

Lymphadenopathy

Dysphagia

Faeces hard

Odynophagia

Pancreatitis chronic

Asthenia

Fatigue

Sensation of foreign body

Cystitis

Ear infection

Eye infection

Gastroenteritis

Gastroeteritis viral

Gingivitis

Infected bite

Iron deficiency

Muscle spasms

Myalgia

Osteoarthritis

Toothache

Laryngitis

Pharyngitis

Tinea pedis

Tonsillitis

Tooth abscess

Gastrointestinal disorder

Clavicle fracture

Viral infection

Alcohol poisoning

Cough

Increased viscosity of upper respiratiory secretion

100%

80%

60%

40%

20%

Study treatment Arm

Ladarixin

Placebo

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ladarixin

2016

Completed Phase 2

~120

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 1 Diabetes (T1D) primarily aim to preserve beta-cell function and manage blood glucose levels. Insulin therapy remains the cornerstone, replacing the insulin that the body can no longer produce. Immunomodulatory therapies, such as IL-8 receptor antagonists like Ladarixin, are being studied for their potential to reduce inflammation and preserve beta-cell function, thereby delaying disease progression. Combination therapies that include immunomodulators and agents that stimulate beta-cell regeneration are also promising, as they address both the autoimmune and regenerative aspects of T1D. These treatments are crucial for T1D patients as they offer the potential to maintain endogenous insulin production and improve long-term glycemic control, reducing the risk of complications.

Cardiovascular effects of GLP-1 receptor agonism.Reducing Type 1 Diabetes Mortality: Role for Adjunctive Therapies?Molecular Mechanism of the Effect of Huanglian Jiedu Decoction on Type 2 Diabetes Mellitus Based on Network Pharmacology and Molecular Docking.