NCT05035368

Ladarixin as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Type 1 Diabetes

Ladarixin 400 mg Twice a Day as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Overweight Insulin-resistant Type 1 Diabetic Patients

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Objectives Primary study objective: To determine whether orally-administered ladarixin versus placebo adjunctive therapy improves insulin sensitivity in overweight, insulin-resistant (IR) type 1 Diabetic (T1D) adult subjects. Secondary study objectives: To determine whether orally-administered ladarixin versus placebo adjunctive therapy is safe and well-tolerated in overweight, IR T1D adult subjects.

Detailed description

This study is a randomized, placebo-controlled, double-blinded, 2-arm, 2-period crossover phase II trial using the CXCR1/CXCR2 chemokine receptor antagonist ladarixin versus placebo as adjunctive therapy to insulin to improve insulin sensitivity as well as glucometabolic outcomes in adult, insulin-requiring, overweight, IR T1D patients. This trial will randomize 38 male and female patients 21-65 years of age, inclusive, with established insulinrequiring T1D and IR. After a 2:1 randomization into a treatment sequence (either ladarixin followed by placebo, or placebo followed by ladarixin, respectively), patients will be followed up for a maximum of 53 weeks. The study database will be locked when the last patient randomized has completed visit 9 (week 52/53) and data have been cleaned.

Conditions

• Type I Diabetes

Interventions

Type	Name	Description
DRUG	Ladarixin	Ladarixin will be administered orally at the dose of 400 mg twice a day at about 12-hour interval (morning and evening).
OTHER	Placebo	Placebo is administered with the same schedule of Ladarixin.

Timeline

• Start date: 2021-09-30
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2021-09-05
• Last updated: 2023-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study