Scientists in America have found that a drug can preserve the body’s insulin-producing cells in people with newly diagnosed type 1 diabetes.
Previous studies have shown that a single course of the anti-CD3 monoclonal antibody drug Teplizumab, given soon after diagnosis, improved the responses of pancreatic beta cells for a year. But the responses waned after 12 months.
To investigate whether two courses of the drug, one year apart, would have a better response, Kevan Herold, professor of immunobiology at Yale School of Medicine, and colleagues treated 52 patients with teplizumab for two weeks after diagnosis, and again after one year.
The randomised, controlled Phase II trials produced impressive result, with the researchers reporting that teplizumab treatment reduced the loss of beta cells considerably after two years.
“There’s a sub-group of people, 45%, that had a terrific response to the drug. In these patients, there was a three-fold improvement in their insulin responses compared to untreated participants,” Prof Herold explained.
“After two years, they’d lost less than 10 percent of their beta cells responses.”
The scientists also found that participants who needed less insulin when they first entered the study responded best to the drug and had better blood sugar control.
Prof Herold and his team now plan to start a Phase III trial that could lead to teplizumab gaining egulatory approval in the US, but not just for newly diagnosed type 1 diabetics.
“If approved, this would be the first drug to change the natural course of type 1 diabetes since insulin,” he added.
The results of the Phase II clinical trials are published in the journal Diabetes.
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