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Henry Ford Hospital Medical Journal

Abstract

Thirty diabetic patients new to insulin were entered in an open label prospective study of biosynthetic human insulin (BHI). All patients experienced symptomatic control of diabetes attributable to dietary and BHI insulin therapy. Detailed six-month evaluation data were reviewed in 19 patients. A significant drop in fasting plasma glucose and glycosylated hemoglobin was noted at two months, and a further modest decrease occurred at six months. E. coli polypeptide antibodies were unchanged from baseline at six months, indicating that no bacterial protein contamination of BHI occurred. Percent binding of serum antibodies to human insulin measured in 19 patients at baseline and at six months showed a statistically significant increase in mean value without accompanying clinical symptoms. Clinical hypoglycemia did not differ from that seen in patients who received animal insulin. Biosynthetic human insulin appears comparable in clinical efficacy and safety to purified pork insulin. Ongoing studies will be required to determine whether BHI is less immunogenic than purified pork insulin.

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