Randomized prospective trial of pure porcine and conventional bovine/porcine insulin.
Use of pure porcine insulin versus partially purified insulin of bovine/porcine origin might be expected to have certain clinical benefits, e.g., a lower incidence of skin reactions, a lower insulin dosage, better diabetes regulation, and greater preservation of endogenous insulin secretion. To test this hypothesis, we randomly assigned 112 newly diagnosed, untreated, insulin-dependent diabetic children to therapy with either pure porcine or partially purified bovine/porcine insulin. They were followed for 1 yr, data being available on at least 90 subjects at each visit. More skin reactions were found in the group treated with the bovine/porcine insulin. This insulin was of higher antigenicity, and binding of radiolabeled insulin (mean +/- SE) by serum from bovine/porcine insulin treatment was 35.5 +/- 2.6 versus 16.8 +/- 1.4% (P less than .001) for pure porcine insulin treatment 12 mo after initiation of insulin therapy. However, throughout the 12 mo of observation the levels of glycosylated hemoglobin, insulin dosage, fasting plasma glucose, and C-peptide concentration were similar for the groups. Reported incidences of hypoglycemia and nocturia were also similar. Thus, insulin-antibody formation and skin reactions were minimized by the use of pure porcine versus partially purified bovine/porcine insulin, but no other clinical advantages were apparent.
D000818:Animals; D000906:Antibodies / Q000378:metabolism; D002096:C-Peptide / Q000097:blood; D002417:Cattle; D002648:Child; D002986:Clinical Trials as Topic; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007328:Insulin / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D008297:Male; D011446:Prospective Studies; D011897:Random Allocation; D012882:Skin Tests; D013552:Swine
D000906:Antibodies; D002096:C-Peptide; D006442:Glycated Hemoglobin; D007328:Insulin