Study Will Compare Avandia’s Effect on Treatment of Type 2 Complications
SmithKline Beecham recently announced plans to initiate a major study to determine if early treatment with Avandia, Glucophage or a sulfonylurea improves and maintains blood sugar control in patients with type 2 diabetes, delays and/or prevents complications such as kidney disease and prevents decline in pancreatic beta-cell function.
According to a SmithKline Beecham news release, the study, called A Diabetes Outcome Progression Trial (ADOPT), will directly compare Avandia to Glucophage or a sulfonylurea. Glucophage and sulfonylureas are traditionally used medications that treat the symptoms of type 2 diabetes. They do not, however, directly target insulin resistance. The ADOPT study will be one of the longest and largest studies of people with type 2 diabetes initiated since the United Kingdom Prospective Diabetes Study.
This phase IV, randomized, double-blind, four-year study will be conducted in 300 sites worldwide and will enroll more than 3,500 recently diagnosed people with type 2 diabetes who have not been previously treated with an oral antidiabetes medication. Patients will be randomized to one of three treatment groups: Avandia, Glucophage or glyburide (glibenclamide in Europe).
The primary objective of the study is to evaluate and compare the metabolic effects of long-term treatment in patients with recently diagnosed type 2 diabetes. Endpoints include the long-term effects of each drug on:
- Durability of improvement in blood sugar control;
- Maintenance and restoration of pancreatic beta-cell function and effects on insulin sensitivity;
- Long-term safety, including liver, cardiovascular and hematological safety;
- Progression of microalbuminuria, which is an indicator of kidney disease and a cardiovascular risk factor;
- Other cardiovascular risk factors, including PAI-1, fibrinogen and C-reactive protein;
- Quality-of-life and pharmacoeconomic profiles.