The efficacy and safety of human insulin (Novo) in insulin-dependent diabetic patients.

Fifty-one insulin-dependent diabetic patients, 26 children and 25 adults, participated in an open uncontrolled study of the safety and efficacy of human insulin (Novo). The patients, who had previously been treated exclusively with porcine insulin, were followed in two outpatient clinics during a 3-mo study period. During the study period the patients' mean insulin dose and postprandial blood glucose level, as well as the number of hypoglycemic episodes, did not change. The level of hemoglobin A1c was unchanged in the children but fell in the adult patients. None of the patients developed lipoatrophy or experienced any allergy or adverse reaction. One patient died of causes unrelated to the diabetes. Mean insulin-binding IgG did not change during the 3-mo study period. After 12 mo of treatment no significant differences were found between the mean level of insulin-binding IgG in patients who had continued treatment with human insulin and patients who had resumed treatment with porcine insulin after the 3-mo study period. It is concluded within the framework of this study that human insulin is safe and that no major differences in metabolic effect between purified porcine insulin and human insulin could be demonstrated. Thus, patients can be transferred from purified porcine insulin to human insulin without any special precautions.