Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

INCLUSION CRITERIA: Diagnosis of type 2 diabetes mellitus for at least one year; Continuous treatment with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months ; Glycated hemoglobin between 7.5 and 11 % units, inclusive; Willingness to accept, and ability to inject insulin glargine therapy EXCLUSION CRITERIA: Stroke, MI, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months; Congestive heart failure requiring pharmacological treatment; Serum creatinine > 1.5 mg/dl for males, or > 1.4 mg/dl for females; Acute or chronic metabolic acidosis, including diabetic ketoacidosis; Planned radiological examinations requiring administration of contrasting agents; Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range; History of hypoglycemia unawareness; Pregnancy or lactation; Failure to use adequate contraception (women of current reproductive potential only); Known hypersensitivity to insulin glargine, rosiglitazone or any of the components of insulin glargine rosiglitazone; BMI >25 kg/m2; Malignancy except basal cell carcinoma within the last five years; History of substance or alcohol abuse within last two years, or current addiction to substance or alcohol abuse; Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study; Incapability to comply with study procedures