To Include Data Showing Greater Blood Sugar Control for Up to Five Years, US FDA Updates GSK Diabetes Drug Label

GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration (FDA) updated the prescribing information for its type 2 diabetes medication, rosiglitazone maleate, to include clinical findings from A Diabetes Outcome Progression Trial (ADOPT). ADOPT is a 4- to 6-year head-to-head study of rosiglitazone maleate versus metformin and glibenclamide monotherapy in recently diagnosed type 2 diabetes patients. ADOPT showed that the percentage of patients with inadequate glucose control at five years was 34 percent with glibenclamide, 21 percent with metformin and only 15 percent with rosiglitazone maleate. The difference between rosiglitazone maleate and the two other treatment options was statistically significant.

GSK is pleased that the FDA has approved inclusion of the results from ADOPT, an important clinical trial that provides substantial long-term efficacy and safety data on rosiglitazone maleate compared to metformin and sulfonylurea,” said Alexander R. Cobitz, MD, PhD, Senior Director, Metabolism, Clinical Development and Medical Affairs, GlaxoSmithKline. “As demonstrated in this study, patients treated with rosiglitazone maleate achieved greater sustained glycemic control which will help them better manage their condition. Better glycemic control has been proven to reduce risks of serious complications associated with type 2 diabetes including blindness, loss of limbs and kidney failure.