Analysis of effectiveness of human U-500 insulin in patients unresponsive to conventional insulin therapy.

OBJECTIVE: To present a retrospective analysis of the effects of human U-500 insulin in 20 patients with type 2 diabetes and insulin resistance.
METHODS: Medical records of 20 patients with type 2 diabetes who had received U-500 insulin for at least 6 months were reviewed to determine glycemic control before and after this therapy. Human regular U-500 insulin therapy was initiated at a unit dosage equivalent to the previous standard insulin dosage. Comparisons of hemoglobin A1c levels, insulin doses, and body mass index at baseline and 6 months after changing to U-500 insulin therapy were analyzed.
RESULTS: In the 10 female and 10 male study subjects, the mean (+/-SD) hemoglobin A1c level was 9.59 +/- 1.37% initially, and it decreased to 8.53 +/- 1.11% at 3 months and to 7.83 +/- 1.26% at 6 months after initiation of U-500 insulin therapy. In comparison with baseline, these decreases were statistically significant. The amount of insulin used and the body mass index did not change significantly from baseline to 6 months after initiation of U-500 insulin treatment.
CONCLUSION: Analysis of data suggests that U-500 insulin therapy yields improved glycemic control in insulin-resistant patients who have poor control of blood glucose with use of standard insulin regimens. There is no proof, however, that improved glycemic control by this method decreases diabetes-related complications or improves survival. Further studies must be performed before U-500 insulin can be recommended as a standard therapy for patients with insulin resistance.