Baricitinib for Type 1 Diabetes

(BARICADE-DELAY Trial)

This trial tests whether baricitinib, a medication, can delay the onset of type 1 diabetes in individuals likely to develop the condition. Participants will receive either baricitinib or a placebo (a pill with no active medicine) to determine any difference in diabetes onset. It may suit those already showing early signs of type 1 diabetes, such as having two or more specific antibodies linked to the disease. As a Phase 3 trial, this represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that baricitinib is generally safe for people with type 1 diabetes. In a previous study, patients who took baricitinib daily for 48 weeks maintained healthy beta-cell function, crucial for insulin production. This finding supports its safety and effectiveness.

The FDA has already approved the treatment for other uses, indicating a well-understood safety profile. However, like any medication, baricitinib can cause side effects, commonly mild to moderate issues such as headaches and colds.

Baricitinib is unique because it offers a fresh approach to managing Type 1 Diabetes by targeting the immune system's role in the disease. Unlike traditional treatments that focus on insulin replacement, Baricitinib works by modulating the immune response, potentially preserving the insulin-producing cells in the pancreas. Researchers are excited because this could mean better control of blood sugar levels and a reduction in the need for insulin injections, ultimately improving quality of life for patients.

Research has shown that baricitinib, a type of medication, can slow the progression of type 1 diabetes (T1D). In this trial, participants will receive either baricitinib or a placebo. Studies have found that people taking baricitinib produce more insulin and maintain stable blood sugar levels compared to those on a placebo. This treatment also protects the insulin-producing cells, crucial for blood sugar control, over a 48-week period. Additionally, patients on baricitinib have reported needing less external insulin and spending more time with blood sugar levels in the target range. However, these benefits may decrease if the treatment stops.¹³⁴⁵⁶