Clinical Studies on the Comparative Evaluation of Human Monocomponent Insulin and Porcine Monocomponent Insulin in Diabetic Patients: A Double-blind, Multicenter Clinical Study (1)

Aims, Methods, Patient Background, Safety and Global Judgement

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. Of a total of 190 diabetics participating in the study, 182 were finally included in the analysis of patient data (93 receiving HMI, 89 receiving PPI). Actrapid and Monotard prepartions of both HMI and PPI were employed. The compositions of the HMI and PPI groups were equivalent in term of the patients' backgrounds and compliance with the physicians' directions. In the final analysis, no statistically significant differences were observed between the two groups with regard to the global improvement rating, overall safety rating and global utility rating, in comparison with the initial stages. These data were subjected to further analysis in different stratified subgroups of patients. With regard to the type and frequency of adverse effects, also no significant differences were observed between the two groups. In addition, no abnormal finding which could be considered to be due to the effects of the test drugs were observed in the laboratory test results.