Clinical Studies on the Comparative Evaluation of Human Monocomponent Insulin and Porcine Monocomponent Insulin in Diabetic Patients: A Double-blind, Multicenter Clinical Study (2)

Results (Evaluation of Blood Glucose, Body Weight, and Insulin Antibodies)

Abstract

A multi-center double-blind study was conducted on human monocomponent insulin (HMI) preparations, enzymatically semisynthesized from porcine insulin, for their safety, efficacy and immunological evaluation. Purified porcine insulin (PPI) preparations were employed as the control agents. The subjects of this study were 182 diabetics who had been under treatment with PPI exclusively. During the administration period, there were certain time point where the daily insulin requirement and the frequency of daily injectons were found to be significantly larger statistically in the HMI group in comparison with the PPI group.
With respect to fasting blood glucose level, the HMI group showed a statistically higher level than the PPI group at several time points, while no significant difference was observed between the two groups regarding the HbA, level. There were some time points where the anti-insulin IgG antibody level tended to be lower in the HMI group than in the PPI group and at some time points the insulin-specific IgE antibody level was statistically lower in the HMI group. Thus, HMI seems to be less immunogenic compared with PPI. On the basis of the above results, it can be concluded that HMI's clinical utility is equal to that of PPI as long as it is employed bearing in mind that there may be some differences between HMI and PPI with respect to drug absorption from the site of subcutaneous injection.