In a world-first human trial conducted by researchers at St Vincent’s Institute of Medical Research (SVI) in Melbourne, it has been demonstrated that a commonly prescribed rheumatoid arthritis drug has the potential to suppress the progression of type 1 diabetes. The trial, led by SVI’s Professor Thomas Kay, was published in the New England Journal of Medicine and revealed that the drug baricitinib can safely and effectively preserve the body’s insulin production and slow the advancement of type 1 diabetes in individuals who begin treatment within 100 days of diagnosis.
Type 1 diabetes is characterized by the presence of numerous insulin-producing cells at the time of initial diagnosis. The researchers aimed to determine whether they could prevent further destruction of these cells by the immune system. “We showed that baricitinib is safe and effective at slowing the progression of type 1 diabetes in people who have been recently diagnosed,” stated Professor Kay.
This pioneering research offers hope as the first disease-modifying treatment for type 1 diabetes that can be taken orally.
Professor Kay expressed his excitement at being the first group worldwide to test the efficacy of baricitinib as a potential treatment for type 1 diabetes. “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,” he said.
Previously, individuals with type 1 diabetes relied on insulin administered via injection or infusion pump. The trial demonstrated that, if initiated early after diagnosis and maintained throughout the treatment period, baricitinib enabled the production of insulin to be sustained. Participants in the trial who were given the drug required significantly less insulin for their treatment.
Managing type 1 diabetes, a lifelong autoimmune disease, poses a significant burden on diagnosed individuals and their families. It necessitates meticulous glucose monitoring and round-the-clock insulin administration to sustain life.
Prior to the discovery of insulin over 100 years ago, type 1 diabetes was fatal. Despite the life-saving role of insulin, the therapy itself can be potentially hazardous if not administered in the proper dosage, and the condition still carries long-term complications such as heart attack, stroke, vision impairment, kidney disease, and nerve damage.
“We are very optimistic that this treatment will become clinically available,” stated Professor Helen Thomas, the preclinical lead on the trial. “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.”
The trial, which was randomized, double-blind, and placebo-controlled, monitored the blood glucose and insulin production of 91 participants over the course of one year. Among them, 60 were administered baricitinib, while 31 received a placebo. The trial participants were all aged between 10 and 30 years old and began treatment within 100 days of being diagnosed with type 1 diabetes.
Throughout the trial, participants continued with their prescribed insulin therapy. The researchers monitored their total daily insulin dose, the amount of insulin produced by their own pancreas, blood glucose levels, and HbA1C levels. HbA1c, or glycated hemoglobin, is a measure of average blood glucose levels over the past two to three months.
Baricitinib functions by inhibiting an enzyme that typically transmits signals regulating the immune system and inflammation. The drug is currently prescribed for the treatment of rheumatoid arthritis, which is another autoimmune disease. It is believed that the drug similarly suppresses the immune response against insulin-producing cells in individuals with newly diagnosed type 1 diabetes, thereby delaying the onset of severe symptoms, improving glucose control, and reducing the potential for long-term detrimental health effects.
1. Source: Coherent Market Insights, Public sources, Desk research
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