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

Data Provides Further Information on Rosiglitazone Maleate as a Safe and Effective Treatment Option for Appropriate Type 2 Diabetes Patients

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."

Study Design

ADOPT was a large, international, multicenter, randomized, double-blind, parallel-group study involving 4,351 people, aged 30-75 years who were recently diagnosed with type 2 diabetes (3 years) from more than 400 sites throughout North America and Europe. ADOPT assessed the cumulative incidence of monotherapy failure at five years with rosiglitazone maleate, metformin, glibenclamide, as defined by consecutive fasting plasma glucose (FPG) >180 mg/dL.

Patients were randomized to receive either rosiglitazone maleate 4 mg once daily, glibenclamide 2.5 mg once daily, or metformin 500 mg once daily, and doses were titrated to optimal glycemic control up to a maximum of 4 mg twice daily for rosiglitazone maleate, 7.5 mg twice daily for glibenclamide, and 1,000 mg twice daily for metformin. Initial treatment with rosiglitazone maleate reduced the risk of monotherapy failure in people with type 2 diabetes by 32 percent compared to metformin (p<0.001), and 63 percent compared to glibenclamide (p<0.001) at five years.

Type 2 diabetes is a chronic, progressive and serious disease that occurs either when the body does not produce enough insulin or when the body does not respond properly to its natural insulin. GSK’s diabetes drug rosiglitazone maleate, along with diet and exercise, helps improve blood sugar control in patients with type 2 diabetes. Patients are advised to consult their physicians to learn more about effectively controlling blood sugar and managing diabetes. Clinical trial data demonstrate that rosiglitazone is the only drug in its class to have been proven to control blood sugar for up to five years.

Safety Information from ADOPT

In ADOPT, rosiglitazone maleate was reported to be generally well-tolerated among the large cohort of people with type 2 diabetes who were followed for up to six years. Incidence of congestive heart failure (CHF) adverse events was the same among patients treated with rosiglitazone maleate (0.8 percent) and metformin (0.8 percent); however, people given glibenclamide experienced a lower rate of CHF events (0.2 percent).

Over the duration of the study, commonly reported adverse events included edema, weight gain and hypoglycemia. In ADOPT, more women treated with rosiglitazone maleate experienced fractures than did those who received either metformin or glibenclamide. The majority of fractures observed were in the upper arm, hand, or foot. However, the number of women with a hip or spine fracture was low and similar among the three treatment groups. The incidence of fractures for men in ADOPT was similar among the three treatment groups.

Other cardiovascular safety data for GSK’s diabetes treatment in ADOPT were added to the label in November 2007 and show that the results for three endpoints (major cardiovascular events, heart attacks and total mortality) were not statistically significantly different between rosiglitazone and comparators.

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