Clinical Studies on the Comparative Evaluation of Human Monocomponent Insulin and Porcine Monocomponent Insulin in Diabetic Patients: A Double-blind, Multicenter Clinical Study —Interim Report— the Study Group for Human Monocomponent Insulin

Abstract

Human monocomponent insulin, semi-synthetized enzymatically by modification of porcine insulin, was compared with purified porcine insulin with respect to its safety, efficacy and immunological changes. A double-blind method was applied. The preparations tested were Actrapid and Monotard insulins. The scheduled testing period is 96 weeks and is in progress. The results analyzed at this time are the interim results in patients who have been treated and observed for more than 24 weeks. A total of 153 patients were collected, all diabetics of either type 1 or type 2 and treated exclusively with purified porcine insulin priror to the present study. Analysis was carried out on 145 cases, with the remaining 8 cases excuded because they were judged to fall within the exclusion criteria. No marked differences in the patients' backgroud data, i.e., age, type of diabetes, obesity index, age at onset of diabetes, duration of diabetes and diabetic complications, were observed between the group treated with human monocomponent insulin and the group given purified porcine insulin. There was a tendency for the purified porcine insulin group to show a higher incidence of “improved” cases in the global improvement rating and “useful” cases in the global utility rating compared with the human monocomponent insulin group. No statistical differences in body weight, anti-insulin IgG antibodies or insulin-specific IgE antibodies were observed between the two groups. There were no adverse effects, although one case did develop an insulin allergy at about one month, and another case showed lipoatrophy in the 12 th week of the study. These two cases were, however, able to continue the treatment. There were no abnormal laboratory findings judged to be directly due to either of the test drugs. These results suggest that human monocomponent insulin is as safe and effective as purified porcine insulin. In conclusion, the human monocomponent insulin can be considered to have a similar clinical usefulness to the purified porcine insulin. © 1984, THE JAPAN DIABETES SOCIETY. All rights reserved.