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Results Announced from ADOPT (A Diabetes Outcome Progression Trial)

Dec 5, 2006

Landmark Study compares effectiveness of single therapy with rosiglitazone, sulfonylurea and metformin in a head to head comparison with 4360 newly diagnosed Type 2’s. CAPE TOWN, South Africa – December 4, 2006 Results from ADOPT (A Diabetes Outcome Progression Trial) demonstrated that initial treatment with Avandia® (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 glyburide (p<0.001) at five years. The results of this international study involving 4,360 people recently diagnosed with type 2 diabetes were today published in the New England Journal of Medicine and presented at the 19th World Diabetes Congress of the International Diabetes Federation (IDF).

Rosiglitazone was more effective than metformin or glyburide in delaying the progressive loss of blood sugar control, as measured in the study by fasting plasma glucose (FPG) and Hemoglobin A1c levels (HbA1c). The primary reasons for loss of blood sugar control are increasing insulin resistance and declining beta-cell function. ADOPT demonstrated that rosiglitazone significantly improved insulin sensitivity (p<0.001 versus metformin or glyburide) and reduced the rate of loss of beta-cell function (p=0.02 versus metformin; p<0.001 versus glyburide).

“ADOPT provides evidence supporting earlier treatment with rosiglitazone in the management of type 2 diabetes. This is the first long-term study to demonstrate that the progressive loss of blood sugar control can be delayed and target blood sugar levels can be maintained for a longer period with rosiglitazone than with metformin and glyburide – the two most frequently prescribed oral antidiabetic agents,” said Dr. Steven Kahn, professor of medicine, VA Puget Sound Healthcare System and University of Washington School of Medicine, Seattle, Wa. and Dr. Giancarlo Viberti, professor of diabetes and metabolic medicine, King’s College School of Medicine, UK. “The more durable effect on blood sugar with rosiglitazone was also consistent with greater improvements in
core defects of the disease, including significant effects on insulin resistance and beta-cell function.”

The study included 4,360 drug-naive people, aged 30-75 years who had been recently diagnosed with type 2 diabetes (£ 3 years). Only people whose diabetes had been previously managed with diet and exercise were included. People from more than 400 sites throughout North America and Europe participated in the study. People in the study had FPG concentration ranging from 126 to 180 mg/dl (7-10 mmol/l) at randomization.

The cumulative incidence of monotherapy failure at five years with rosiglitazone, metformin, glyburide, as defined by consecutive FPG >180 mg/dl (>10 mmol/l). When ADOPT was designed, HbA1c was not chosen as the primary outcome because the guidelines at the time focused largely on FPG. Nevertheless, HbA1c data collected in the study as a secondary endpoint provided results applicable to current clinical practice.

1.ADOPT was funded by GlaxoSmithKline


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