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Drug Preserves Beta Cells in New Cases of Type 1 Diabetes
Authors plan late-stage trial of teplizumab (August 6)
A drug in clinical trials has been shown to preserve insulin-producing pancreatic beta cells in nearly half of subjects newly diagnosed with type 1diabetes (T1D). Results of the phase 2 trials are published in Diabetes.
In randomized, controlled trials, investigators at Yale University treated 52 patients with teplizumab for two weeks after diagnosis, and again after one year.
The results were impressive, report the researchers. Teplizumab treatment significantly reduced the loss of beta cells after two years; in fact, the level at year two was, on average, 75% higher in the teplizumab arm of the trial than in the control group.
“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,” said lead investigator Dr. Kevan Herold. “After two years, they’d lost less than 10 percent of their beta cell responses.”
Herold and his team also studied who responded best among the group of patients. “Responders tended to be those who needed less insulin when they first got into the trial, and had better control of their blood sugar levels,” he said.
Herold and his colleagues are hoping to start a phase 3 trial that could lead to FDA approval of the drug, but not just for newly diagnosed T1D patients. Herold is also principal investigator of a diabetes prevention trial at Yale, to determine whether the same drug can stop the disease in people who are at high risk of developing type 1 diabetes.
Source: Medical Xpress; August 6, 2013.