A Phase 2, Multicentre, Randomized, Double-blind, Placebo-controlled Study in Patients With New-onset Type 1 Diabetes
Status:
Completed
Trial end date:
2019-05-15
Target enrollment:
Participant gender:
Summary
The objective of this clinical trial is to investigate whether ladarixin has sufficient
activity (preservation of β-cell function and slow-down of the progression of T1D) to warrant
its further development (proof of concept trial). The safety of ladarixin in the specific
clinical setting will be also evaluated.
The study is a phase 2, multicentre, double-blind study. 72 patients with new-onset type 1
diabetes (T1D) were planned to be involved, randomly (2:1) assigned to receive either
ladarixin treatment (400 mg b.i.d. for 3 cycles of 14 days on/14 days off - treatment group)
or placebo (control group).
Recruitment was competitive among the study sites, until the planned number of patients was
enrolled. A total of 76 patients were actually recruited.