A study of the comparative safety and efficacy of neutral soluble human (semi-synthetic) and porcine monocomponent insulin in non-diabetic subjects.
Neutral soluble human (semi-synthetic) and porcine insulin and diluting medium were administered subcutaneously in a randomized fashion to six fasting normal male subjects. The plasma glucose, C-peptide and insulin response was observed for a period of two hours before and six hours after injection of insulin (0.075 m/kg) into the anterior abdominal wall. The hypoglycaemic response was identical for the two insulins with the plasma glucose values reaching a nadir at 90--120 minutes and returning to within 10% of basal levels by six hours. Also similar peak plasma insulin values were achieved with human and porcine insulin by 50--60 minutes post-injection. The C-peptide response following the administration of both insulins suggested equal suppression of endogenous beta cell secretion. The two insulins were well tolerated with no immediate or delayed allergic reactions in any subject. These results suggest that human (semi-synthetic) and porcine soluble monocomponent insulins under the described experimental conditions are bioequivalent.
D000328:Adult; D000818:Animals; D001682:Biological Availability; D001786:Blood Glucose / Q000032:analysis; D002096:C-Peptide / Q000097:blood; D006801:Humans; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000097:blood; D008297:Male; D013552:Swine; D013810:Therapeutic Equivalency
D001786:Blood Glucose; D002096:C-Peptide; D007328:Insulin