A Phase 3 Randomized Controlled Trial of Ladarixin in New-Onset Type 1 Diabetes (H-49339)
Study Goal(s): This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladaraxin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline.
Eligibility criteria: 14-20 years old adolescents and young adults with new-onset type 1 diabetes (BCM/TCH Criteria)
Investigators: Mustafa Tosur, M.D. (site principal investigator), Maria J. Redondo, M.D., Ph.D. (co-investigator), Serife Uysal, M.D. (co-investigator), Tracy Patel, M.D. (co-investigator)
Supported by: Dompe Pharmaceuticals