Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes

INCLUSION CRITERIA: Males and females 40 to 75 years of age (inclusive at the time of screening) Type 2 diabetes mellitus as defined by the WHO criteria, diagnosed for at least 1 year Subjects receiving 1.5 to 3g of metformin alone at a constant dose for at least 8 weeks prior to visit 1 Patients with 6.5% < HbA1c > 8% at visit 1 and visit 2 25 < BMI < 35 EXCLUSION CRITERIA: Patient with type 1 diabetes Treatment with other hypoglycaemic agents than metformin in the last 3 months FPG >200 mg/dL at visit 2 Hypersensitivity to the studied treatments (rosiglitazone, metformin chlorhydrate, gliclazide) Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction Respiratory insufficiency Subjects who have required the use of insulin for glycaemic control in the past 6 months prior to visit 1 (except during pregnancy or acute episodes such as hospitalization, trauma or infection) or subjects with a history of metabolic acidosis including diabetic ketoacidosis Anemia defined by haemoglobin concentration <11.0 g/dL for males and <10.0 g/dL for females Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135.0 µmol/L in males and ≥110.0 µmol/L in females and/or creatinine clearance <40 mL/min Presence of clinically significant hepatic disease, with ALT, AST, total bilirubin, alkaline phosphatase >2.5 times the upper limit of the normal reference range Subjects with chronic diseases requiring periodic ot intermittent treatment with oral or IV corticosteroids Subjects receiving danazol, miconazole or phenylbutazone Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance Women who are lactating, pregnant or planning to become pregnant Any clinically significant abnormality identified at screening which, in the investigator's judgement, makes the subject unsuitable for inclusion in the study Use of any other investigational agent within 30 days or 5 half-lives (whichever is longer) prior to visit 1 Subjects who receive or anticipate receiving radiocontrast dye during the study