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The aim of this paper is to describe the long-term effect of U-500 insulin use on biomedical outcomes in a cohort of patients with diabetes mellitus.We carried out a case record review of 81 patients from a multicultural population who had received U-500 insulin. We recorded data before the introduction of U-500 and at data collection (February 2007) including: demographic information, weight, insulin dose, HbA1c, lipid profile and blood pressure.The results showed that the mean duration of treatment was 30±22.6 months (range 1-98). The median insulin dose was 292 vs 320 units/day (range 122-600 vs 120-760 units/day). Mean HbA1c at baseline improved from 10.0±1.8% to 8.7±2.0% (p<0.0001). Patients using U-500 insulin for a longer period (>36 months) showed a greater reduction in HbA1c (1.8±1.5% vs 0.99±1.8%, p<0.05). An improvement in HbA1c was seen in all ethnic groups. Mean total cholesterol reduced from 4.9±1.4mmol/L to 4.3±1.0mmol/L (p<0.0001) and triglycerides from 4.3±4.5mmol/L to 3.0±3.0mmol/L (p<0.001). Significant weight gain was seen.It was concluded that long-term glycaemic control improved with the use of U-500 Human Actrapid in all ethnic groups (p<0.05) at the expense of weight gain.U-500 Human Actrapid is a valuable treatment option in patients with diabetes and severe insulin resistance.