What’s happening?
Earlier today, Eli Lilly and Company announced that they are launching two new clinical trials for baricitinib in type 1 diabetes (T1D). These phase 3 trials will investigate whether the drug can delay T1D onset or progression and will open for recruitment soon. Read on to learn more about the trials, why this matters, and what led to this exciting news.
Baricitinib has shown promise 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.
JAK inhibitors
JAK inhibitors, including baricitinib, are already FDA-approved for other autoimmune diseases, such as rheumatoid arthritis, alopecia, and more. JAK signaling pathways are associated with overactive immune responses, so blocking this pathway may turn down the immune response.
The phase 2 Breakthrough T1D-funded BANDIT study was key in showing that this drug is safe and effective in T1D. This study was led by Professor Thomas Kay, MBBS, Ph.D., and his team at St. Vincent’s Institute of Medical Research in Australia. In this trial, more than 90 newly diagnosed individuals with stage 3 T1D between the ages of ten and 30 were treated with either baricitinib (as a single, daily oral tablet) or placebo for 48 weeks.
The results were positive: people treated with baricitinib had increased insulin production, spent more time-in-range, needed less external insulin, and experienced minimal side effects. These data were published in the prestigious New England Journal of Medicine and inspired the launch of another clinical trial (JAKPOT T1D) investigating different JAK inhibitors in preserving beta cells in T1D.
Thanks to the BANDIT study, which stemmed from years of work with Lilly to supply the drug for the trial, we got the convincing data needed to move baricitinib to phase 3—and one step closer to people with T1D.
The new studies
The new studies will be recruiting soon at medical centers around the globe. Participants in either trial will randomly receive either baricitinib or placebo. The studies are also double-blinded, meaning that neither the study team nor individuals will know whether they are administering or receiving baricitinib or a placebo. Importantly, baricitinib is a once-daily oral pill—meaning its use is simple and easy.
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
- Time commitment: Up to approximately five years
- 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
- Time commitment: About 60 weeks
- Primary endpoint: C-peptide preservation (a measure of insulin production)
Breakthrough T1D is a supporter of baricitinib
Breakthrough T1D has been a tireless advocate for the use of JAK inhibitors in T1D. In conjunction with our Australia affiliate, we funded the BANDIT study, which generated the positive data that provided the basis for these new clinical trials.
Baricitinib is a cornerstone of our Disease-Modifying Therapies Program, which aims to find treatments that can delay, halt, reverse, or prevent T1D. The progression of baricitinib through the pipeline is a perfect example of what we do best: identify a promising therapy, collaborate with industry to support or fund initial clinical trials that establish a therapy’s effects in T1D, facilitate the path towards an industry-sponsored phase 3 trial, and help recruit trial participants to accelerate progress.
We will continue to follow these studies closely and look forward to seeing the results. We encourage our community and supporters to spread the word—if you or anyone you know may be eligible for these trials, share this information!
Finally, we thank Lilly for their shared commitment to our mission: a world without T1D. Industry investment in clinical trials for T1D helps us progress faster—and with partners like Lilly, we’ll get more therapeutic options to people with T1D sooner.
“Breakthrough T1D has been a tireless advocate for the use of JAK inhibitors and has seen the promise of baricitinib as a therapy for type 1 diabetes to preserve insulin production and delay disease progression,” said Breakthrough T1D Chief Scientific Officer Sanjoy Dutta, Ph.D. “We’re thrilled that Lilly is advancing clinical research with baricitinib and thank them for moving us one step closer to making it available for people with type 1 diabetes.”
“In the BANDIT trial we tested for the first time whether baricitinib could preserve insulin-producing cells under autoimmune attack in type 1 diabetes. Years of laboratory work indicated that this drug should be effective. Baricitinib given for 12 months maintained insulin production compared with its loss with placebo. We are grateful to Breakthrough T1D and Lilly for their support of the trial. This was a very exciting outcome from our bench to bedside research. Current insulin therapy is life-saving in diabetes but it is imperfect, and new treatments such as baricitinib show promise. Preservation of insulin production allows the body’s own amazing processes to control blood glucose and reduce the burden of type 1 diabetes. We hope that the BARICADE trials will confirm our findings and extend them to people with earlier diabetes, before insulin is required, and lead to the use of baricitinib in clinical practice for type 1 diabetes.” – Professor Tom Kay, Director, St Vincent’s Institute of Medical Research (SVI) in Melbourne, Australia
Get involved in clinical trials
Clinical trials are key to bringing new treatments, devices, and therapies from labs and into clinics. People who choose to participate in clinical trials help drive progress forward for the entire T1D community. If you or anyone you know is interested in participating in a clinical trial, use our Clinical Trials Matching Tool to find a trial that you may be eligible for. You can also reach out to a Clinical Trial Education Volunteer in your area to connect and answer any questions you may have. Information about the new baricitinib clinical trials will be available on our clinical trials web page when enrollment begins.
