Treatment with Human Insulin (recombinant DNA) in Diabetic Subjects Pretreated with Pork or Beef Insulin: First Results of a Multicenter Study

Abstract

In two double-blind studies 66 insulin-dependent diabetic subjects pretreated with pork insulin were changed to human insulin (recombinant DNA) or a purified pork insulin preparation (regular and NPH insulin). Sixty-five patients previously pretreated with beef insulin were transferred, in a randomized, double-blind fashion, to human insulin and purified beef insulin of the same preparations (regular and NPH insulin). Patients' metabolic control, as demonstrated by fasting and 1-h postprandial blood glucose, HbA1c, and daily insulin dosage, over 4 mo was unchanged in our four groups compared with the values before changing insulin preparation. No severe hypoglycemic attacks or skin reactions were reported.

Hypoglycaemia induced by exogenous insulin –‘human’ and animal insulin compared

“…All but one[61] provided data on hypoglycaemic events, this study simply reporting no events during the investigation. Four studies found no differences in the frequency of hypoglycaemia[2–64]. Two studies reported a statistically insignificantly increased frequency of hypoglycaemia in subjects on ‘human’ insulin as compared to those on insulin of animal origin[65–66].…”

“…Nineteen publications[6–92] compare a period of animal insulin treatment to one of ‘human’ insulin treatment in the same subject. Nine of these studies[75–77,81–83,85–86,88–91] reported no difference between insulin species while a further three[78–79,92] found fewer hypogycaemic episodes with ‘human’ insulin and/or greater awareness of hypoglycaemia.…”

Role of human insulin in the treatment of diabetes

“…In Scandinavia, however, this should not be expected as all insulin is highly purified and insulin resitance due to insulin antibodies is extre¬ mely rare (3,6,7,12,16,24,29).…”

Recombinant Human Insulins – Clinical Efficacy and Safety in Diabetes Therapy

“…Clinical pharmacology studies with recombinant human insulin produced by fermentation in E. coli (Humulin, Eli Lilly, Indianapolis) established bioequivalence of semisynthetic and recombinant Humulin formulations. 14 , 32 , 33 Extensive clinical studies were performed in patients with type 1 and type 2 diabetes 14 , 33 – 36 to confirm consistent clinical efficacy when transferring patients to the recombinant formulations. 14 , 33 , 34…”