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Diabetes Reversed: FDA Authorizes Human Trials

After successfully demonstrating that a groundbreaking treatment strategy can reverse type 1 diabetes in animal studies, the FDA has given the go-ahead for researchers from the University of Pittsburgh Medical Center to begin a phase I trial evaluating the treatment in humans.

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FDA Accepts New Drug Application for Diabetes Drug Galvus

Clinical studies show significant blood sugar reductions (HbA1c) sustained for one year – Trials also show no association with weight gain; overall incidence of side effects, including hypoglycemia and edema, similar to placebo – Regulatory submission includes results from more than 4,300 patients.

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