Two New Trials to Test Whether Baricitinib Can Delay Type 1 Diabetes

Baricitinib is a JAK inhibitor, a type of medication that blocks JAK signaling pathways—cellular communication routes involved in immune responses. These pathways are known to be overactive in type 1 diabetes, where the immune system attacks the body's own insulin-producing beta cells.

By interfering with JAK signaling, baricitinib may help calm this overactive immune response while also protecting remaining beta cells. The drug is already FDA-approved for other autoimmune conditions, including rheumatoid arthritis and alopecia, which means its safety profile in humans is well-established.

The phase 2 BANDIT study, funded by Breakthrough T1D and led by Professor Thomas Kay and his team at St. Vincent's Institute of Medical Research in Australia, provided encouraging evidence. The trial included more than 90 newly diagnosed individuals with stage 3 type 1 diabetes, ages 10 to 30.

Participants received either a daily oral tablet of baricitinib or placebo for 48 weeks. Those treated with baricitinib showed increased insulin production and spent more time within target blood sugar ranges compared to those who received placebo. These results suggested the drug could be safe and effective in type 1 diabetes.

In newly diagnosed type 1 diabetes, the body hasn't yet lost all of its insulin-producing beta cells—a period often called the 'honeymoon period.' During this time, some natural insulin production continues, which can make blood sugar management easier.

If baricitinib can extend this period by preserving more beta cells early in the disease, it could mean better blood sugar control and potentially reduce long-term diabetes-related complications. This is why the new phase 3 trials will specifically investigate whether the drug can delay type 1 diabetes onset or slow its progression.

Eli Lilly announced that two new phase 3 clinical trials will open for recruitment soon. These larger, confirmatory studies will test whether baricitinib's benefits—observed in the earlier phase 2 BANDIT trial—hold up in a broader population and can meaningfully delay or slow type 1 diabetes.

Phase 3 trials are a critical step toward potential FDA approval. If the results are positive, they could pave the way for baricitinib to become an option for people newly diagnosed with type 1 diabetes.

Origin: breakthrought1d.org (News report). Evidence: News report — unverified, pending corroboration. Type1Cure is an information and intelligence hub, not a medical advice service. This article summarizes published research and does not provide diagnosis, treatment, or personal medical guidance. Always talk to your own care team before changing anything about your Type 1 diabetes management.