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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05035368
Study type Interventional
Source Dompé Farmaceutici S.p.A
Contact
Status Withdrawn
Phase Phase 2
Start date September 30, 2021
Completion date June 2023

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