Baricitinib and β-Cell Function in Patients with New-Onset Type 1 Diabetes
Abstract
This phase 2, randomized, placebo controlled trial investigated whether baricitinib, a Janus kinase (JAK) inhibitor, could preserve β cell function in patients with new onset type 1 diabetes. Ninety one participants (aged 10–30 years) were assigned to receive baricitinib (4 mg/day) or placebo for 48 weeks. The primary outcome was the mixed meal stimulated mean C peptide level at week 48. Results showed a significantly higher median C peptide level in the baricitinib group (0.65 nmol/L/min) compared to placebo (0.43 nmol/L/min; P=0.001). Baricitinib also reduced daily insulin requirements (0.41 vs. 0.52 U/kg/day) and improved glycemic variability (coefficient of variation: 29.6% vs. 33.8%). Safety profiles were similar between groups, with no serious adverse events attributed to baricitinib. The findings suggest that baricitinib preserves β cell function and may offer a disease-modifying therapy for type 1 diabetes.