Effect of Baricitinib on Insulin Production in Type 1 Diabetes

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The BANDIT trial is a clinical study designed to evaluate whether the drug baricitinib can slow the progressive loss of insulin-producing beta cells in individuals recently diagnosed with type 1 diabetes (T1D). The study aims to recruit 83 participants aged 12 to 30 years, randomly assigning two-thirds to receive baricitinib and one-third to receive a placebo. The primary goal is to determine if baricitinib can reduce the decline in meal-stimulated plasma C-peptide levels, which serve as a key indicator of beta-cell function and the body's ability to produce insulin. Preserving this natural insulin production in recent-onset T1D is associated with better glucose control and a reduced risk of long-term complications and mortality. The total sample size of 83 was selected based on previous estimates of 2-hour AUC mean C-peptide values and standard statistical power calculations. Specifically, 50 baricitinib-treated and 25 placebo-treated participants with complete data are required to achieve 80% power to detect a 45% increase in mean log(C-peptide +1) (from 0.306 to 0.445 with a standard deviation of 0.2) using a two-sample T-test at a 0.05 significance level (two-sided).

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