UPDATE: March, 2026
Two new Phase 3 clinical trials to study the efficacy of baricitinib as a disease-modifying therapy for T1D.
Baricitinib is a JAK inhibitor that interferes with signaling pathways critical to both immune cells and beta cells. This drug has the potential to extend the “honeymoon period” of T1D, meaning that it could preserve remaining insulin-producing beta cells earlier in disease progression. More beta cells mean better blood sugar management—and potentially reduced long-term complications.
Following very promising results from a Breakthrough T1D-funded Phase 2 study of baricitinib in newly diagnosed individuals with T1D in Australia (see full study write up and results below), Eli Lilly and Company are now launching two new Phase 3 clinical trials. These new international trials will include locations in Canada – click the links below to find out where the studies are recruiting:
BARICADE-DELAY
- Purpose: To determine if baricitinib can delay the onset of clinical stage 3 T1D in people who are at high risk
- Eligibility: Must be between one and 36 years old and be in stage 2 T1D
- Primary outcome: Time to diagnosis of stage 3 T1D
BARICADE-PRESERVE
- Purpose: To determine if baricitinib can preserve beta cell function in people with newly diagnosed T1D
- Eligibility: Must be between one and 36 years old and diagnosed with stage 3 T1D within the last 100 days
- Primary endpoint: C-peptide preservation (a measure of insulin production)
To learn more about the trials and eligibility: BARICADE-PRESERVE and
Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
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Insulin, administered either by pump or multiple daily injection, remains the only available treatment for type 1 diabetes (T1D). Breakthrough T1D is aiming to change that and move beyond insulin by accelerating the development of medicines that prevent, delay, or reverse T1D by targeting the autoimmune response, beta cells, or both. Supporting studies that explore how drugs may preserve beta cell function is key to our disease-modifying therapies portfolio.
In a Breakthrough T1D-funded clinical trial, published in the renowned New England Journal of Medicine , Thomas Kay, M.B.B.S., Helen Thomas, Ph.D., and others demonstrated that baricitinib—a small molecule that blocks Janus Kinase, which is critical to signaling pathways within both immune cells and beta cells in T1D—preserved beta cell function in the disease.
The BANDIT study investigated the use of baricitinib, a treatment already approved by Health Canada for other autoimmune diseases like rheumatoid arthritis, in newly diagnosed T1D individuals. This JDRF-funded study was funded by JDRF and JDRF Australia and conducted at St. Vincent’s Institute of Medical Research in Australia. The study was conducted after years of research by Thomas Kay and others, as well as important work by JDRF advocating for Eli Lilly to provide the baricitinib for the study.
Study Overview
- Participants were between 10 and 30 years old and began taking baricitinib within 100 days of diagnosis
- Participants either received baricitinib or a placebo drug
- The study ran for 48 weeks, and results were analyzed at 12, 24, 36 and 48 weeks
- The primary outcome was average C-peptide (a measure of how much insulin is still being made by a person’s own beta cells) following a standard meal at week 48
- Secondary outcomes were HbA1c (average glucose level over a 2–3-month period), insulin use, and continuous glucose monitor (CGM) measures
Results
In 60 newly diagnosed children and young adults, baricitinib:
- Preserved insulin production, as estimated by C-peptide
- Improved blood-glucose variability (blood glucose levels were more stable) and time-in-range (the percentage of your day within your set blood glucose targets), using a CGM
- Decreased the requirement for external insulin
- Was well-tolerated by the participants
The effect of baricitinib was achieved using a single daily oral tablet, and it’s the first immunotherapy trial to suggest a benefit on CGM measures. (Verapamil, a once-a-day tablet approved for blood pressure management , also preserved beta cell function, but without improvement in CGM measures or insulin requirement.)
What comes next?
Currently, baricitinib is approved for the treatment of rheumatoid arthritis in adults in Canada. It is not however a Health Canada approved therapy for people with T1D. Breakthrough T1D has multiple lines of inquiry to make sure that this and other disease-modifying drugs get to the hands of people with T1D . There are several clinical trials that Breakthrough T1D is exploring to see if baricitinib can be effective if used in conjunction with other therapies, such as Tzield™ (teplizumab-mzwv) or verapamil.
What does this mean for people with T1D?
These promising results show that this drug can extend the honeymoon period (the phase in early type 1 diabetes development where the body is still producing some of its own insulin), but more studies are needed before it can become available to the T1D community. As this drug is already approved for use in rheumatoid arthritis (RA) in Canada, the path to its potential use in T1D may be more rapid. Studies that explore the use of disease-modifying drugs, such as baricitinib orustekinumab, in another Breakthrough T1D-funded trial currently recruiting in Canada, are key to helping Breakthrough T1D address the autoimmunity behind T1D.
This treatment is not currently available in Canada for people with T1D, but Breakthrough T1D Canada will share further updates and results as they become available.
