Patients were eligible for inclusion in the study if they were males or females aged 18-75 with Type II Diabetes Mellitus - T2DM - (defined by the criteria of the American Diabetes Association (12)), were receiving an oral hypoglycemic agent (OHA) or insulin and had given written informed consent, where required. Measurement of glycosylated hemoglobin (HbA1c) performed at the diagnosis and within the previous three months was collected; if the measure was not available for the period, the sponsor supported the laboratory test when necessary, according to the physician's judgment of the patient's need.