Immunogenicity of highly purified porcine and human insulins in diabetic patients with high titers of insulin antibody

Abstract

Twenty-nine non-insulin-dependent diabetic Chinese subjects previously treated with conventional porcine isophane insulin (NPH) for a period of time, whose titer of serum insulin antibody was greater than 40% were changed to either highly purified pork insulin (Nordisk, Denmark) or human insulin of recombinant DNA origin (Eli Lilly, USA) for 1 year in a double-blind and randomized trial. The human (n = 16) and pork insulin (n = 13) groups were carefully matched for age, sex and measures of metabolic control. In highly purified pork-insulin-treated patients, the glycated hemoglobin and fasting blood sugar values began to fall significantly from a mean of 13.2% to 12.3% (p less than 0.05) and 228 mg/dl to 183 mg/dl (p less than 0.005), respectively, 2 months after the commencement of this study, whereas insulin antibody levels began to fall significantly from a mean of 61.8% to 49.5% (p less than 0.01) 6 months after the start of the study. Also, daily insulin doses increased significantly from a mean of 58 units to 70 units (p less than 0.005) 6 months after the start of the study. In human-insulin-treated patients, there were no significant changes in the glycated hemoglobin values. The fasting blood sugar levels fell significantly (p = 0.0515) at the end of the study period but the insulin antibody levels did not show any significant change during the same study period. Daily insulin dose increased significantly from a mean of 51 units to 57 units (p less than 0.01) 4 months after beginning the study.(ABSTRACT TRUNCATED AT 250 WORDS)