Type 1 diabetes results from the immune system mistakenly attacking and destroying the insulin-producing cells in the pancreas. Once these cells are lost, they cannot be regenerated. Individuals diagnosed with type 1 diabetes require lifelong dependence on insulin, administered through injections or infusion pumps.
While insulin is adequate, it falls short of replicating the rapid response of a healthy pancreas to changes in blood glucose levels. Relying on insulin introduces challenges in monitoring and managing glucose levels effectively, creating significant issues for individuals with type 1 diabetes.
The world-first human trial, led by Professors Thomas Kay and Helen Thomas, showed that a commonly prescribed rheumatoid arthritis drug, baricitinib, can safely and effectively preserve the body’s insulin production and suppress the progression of type 1 diabetes.
This groundbreaking research holds promise as the first disease-modifying treatment for type 1 diabetes that can be administered in tablet form.
In a randomized, double-masked, placebo-controlled human trial, the drug baricitinib was evaluated for its impact on blood glucose and insulin production in 91 participants over one year. Among them, 60 received baricitinib, while 31 received a placebo. All participants were aged between 10 and 30 years and had been diagnosed with type 1 diabetes within 100 days before starting the trial.
Throughout the study, participants continued their prescribed insulin therapy. The researchers monitored various parameters, including total daily insulin dose, endogenous insulin production, blood glucose levels, and HbA1c levels, which reflect average blood glucose levels over the last two to three months.
Baricitinib blocks an enzyme that transmits signals regulating the immune system and inflammation. Currently prescribed for rheumatoid arthritis, another autoimmune disease, the drug is believed to suppress the immune response against insulin-producing cells in individuals with newly diagnosed type 1 diabetes.
This suppression may delay the onset of full-blown symptoms, improve glucose control, and reduce the potential for detrimental long-term health effects.
Professor Kay said, “It is tremendously exciting for us to be the first group anywhere in the world to test the efficacy of baricitinib as a potential type 1 diabetes treatment.”
“Up until now, people with type 1 diabetes have been reliant on insulin delivered via injection or infusion pump. Our trial showed that, if started early enough after diagnosis, their insulin production was maintained while the participants remained on the medication. People with type 1 diabetes in the trial who were given the drug required significantly less insulin for treatment.”
Professor Helen Thomas, preclinical lead on the trial, said, “We are very optimistic that this treatment will become clinically available. This would be a huge step-change in how type 1 diabetes is managed, and we believe it shows promise as a fundamental improvement in the ability to control type 1 diabetes.”
Journal Reference:
- Michaela Waibel, John Wentworth et al. Baricitinib and β-Cell Function in Patients with New-Onset Type 1 Diabetes. N Engl J Med. DOI: 10.1056/NEJMoa2306691