[Comparative multicenter study of bovine insulin with forms more purified of swine and human insulin in the treatment of type 1 diabetes mellitus]

Abstract

A multicentric double-blind randomized study was organized to investigate the relationship between insulin antibodies and metabolic control in type I diabetics who changed from bovine insulin to monopic porcine and monocomponent human insulin. Twenty eight type I diabetic patients treated with bovine insulin (proinsulin less than 3,000 ppm) were selected. In a 6 month study, 9 patients maintained bovine insulin, 9 changed to monopic porcine insulin (proinsulin less than 10 ppm) and 10 to human insulin (proinsulin less than 1 ppm). The insulin were a gift from Biobras laboratory. The insulin antibodies (IA) were measured by an ELISA method and the metabolic control assessed by fasting blood sugar (FBS), 24 hour glucosuria and glycated protein (GP) measured by affinity chromatography method. After switching insulin therapy, IA decreased with porcine and human insulin, but increased with bovine insulin. Concerning metabolic control, only an increase of FBS with human insulin was found. In the beginning of study, there was negative correlation between IA and 24h glucosuria (rs = -0.509; p = 0.006). In conclusion, there was no improvement of metabolic control, in spite of a decrease of IA in type I diabetics treated during 6 months with less immunogenic insulin preparations.