A comparison of the effects of human and animal insulin as well as of the adverse reaction profile did not show clinically relevant differences. Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high-quality randomised clinical trials. The story of the introduction of human insulin might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety.
Immunogenicity of highly purified porcine and human insulins in diabetic patients with high titers of insulin antibody.
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)