N Engl J Med

Study examines JAK inhibitor’s impact on β-cell function in new-onset T1DM

December 12, 2023

Among patients with recently-diagnosed T1DM, daily treatment with baricitinib over 48 weeks resulted in higher C-peptide levels compared with placebo, suggesting that β-cell function was preserved.

• In the phase 2 BANDIT trial, patients with type 1 diabetes diagnosed during the previous 100 days were assigned to receive baricitinib (4 mg once daily) or matched placebo orally for 48 weeks. Primary outcome was the mean C-peptide level, determined from the area under the concentration–time curve, during a 2-hour mixed-meal tolerance test at week 48. Secondary outcomes included change from baseline in HbA1c level, daily insulin dose, and measures of glycemic control assessed via continuous glucose monitoring.
• A total of 91 patients received baricitinib (n=60) or placebo (n=31). The median of the mixed-meal–stimulated mean C-peptide level at week 48 was 0.65 nmol/L/min in the baricitinib group vs. 0.43 nmol/L/min in the placebo group (P=0.001). Mean daily insulin dose at 48 weeks was 0.41 U/kg of body weight per day (95% confidence interval [CI], 0.35-0.48) in the baricitinib group vs. 0.52 U/kg per day (95% CI, 0.44-0.60) in the placebo group. HbA1c levels were similar in the two groups.
• The mean coefficient of variation of the glucose level at 48 weeks, as measured by continuous glucose monitoring, was 29.6% (95% CI, 27.8-31.3) in the baricitinib group and 33.8% (95% CI, 31.5-36.2) in the placebo group. Frequency and severity of adverse events were similar between groups, and no serious adverse events were attributed to baricitinib or placebo.

Source:

Waibel M, et al. (2023, December 7). N Engl J Med. Baricitinib and β-Cell Function in Patients with New-Onset Type 1 Diabetes. https://pubmed.ncbi.nlm.nih.gov/38055252/