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

To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin

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