A phase 2b, single-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of oral Ladarixin in association with a single low dose of Antithymocyte Globulin in patients with new-onset autoimmune type 1 diabetes.

new-onset autoimmune type 1 diabetes

The primary endpoint of the study is the change from baseline in the area under the stimulated C-peptide curve (YAUC) at 2 hour MMTT conducted at the 12 month visit.

Changes in: 1) fasting and stimulated C-peptide 2) HbA1c 3) daily insulin requirements throughout the study 4) time in range (70-180 mg/dl), time in tight range (70-140 mg/dl), time below range (<70 mg/dl), glucose management index by CGM and %CV as measure of glucose variability 5) QoL, patient treatment satisfaction and fear of hypoglycemia will be assessed using the Diabetes-Specific Quality of Life (DSQoL) Questionnaire and the FH-15 Questionnaire, both validated in Italian. 6) a

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