Design and Objectives
ADOPT was designed to evaluate the long-term efficacy of monotherapy with rosiglitazone on glycaemic control and on the progression of pathophysiological abnormalities associated with type 2 diabetes, as compared with metformin or glibenclamide (glyburide) monotherapy, in patients recently diagnosed with type 2 diabetes. The primary assessment of treatment effectiveness is the time from randomisation to monotherapy failure. It is expected that ADOPT will provide data on the effects of mechanistically differing treatment options on metabolic control, beta-cell function, and markers of macrovascular disease risk in type 2 diabetes.
Primary inclusion criteria
- Newly-diagnosed patients (≤3 years) with type 2 diabetes
- Fasting plasma glucose (FPG) range of 126-240 mg/dL (7.0-13.3 mmol/l) at screening
- No previous treatment with oral or parenteral glucose-lowering therapy
Primary exclusion criteria
- History of lactic acidosis
- Anaemia (<11 g/dL for males, <10 g/dL for females)
- Unstable or severe (NY Heart Association class 3 or 4) angina
- Any NY Heart Association class of congestive heart failure
- Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids
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