Summary
The immunogenicity of pork Monocomponent (MC) Lente insulin (Monotard®) was studied for more than one year in a clinical trial series of 43 insulin-dependent diabetics in comparison with Monospecies (MS) Lente pork insulin (5 X crystallized, not monocomponent). The antigenicity was estimated by determination of total extractable serum insulin by radioimmunoassay and of I-125 insulin-binding of the serum IgG measured by radioimmunoelectrophoresis. MC Lente insulin was nonimmunogenic in newly diagnosed diabetics: at the end of the observation, the antibody titre was generally under the level of detection. Long-term diabetics transferred to MC Lente insulin from conventional insulin preparations showed a marked reduction in the high initial levels of insulin antibodies, sometimes with a multiphasic pattern; low initial levels remained unchanged at the end of the trial. MS Lente insulin was found to be, even if weakly, immunogenic in newly diagnosed diabetics. In long-term insulin-treated diabetics transferred to MS Lente insulin a tendency to reduction in the high antibody starting level was often observed. Diabetic manifestations such as high insulin requirement, insulin allergy, insulin lipoatrophy and diabetic microangiopathy showed — in some instances — a clinical course independent of immunological modifications. Clinical control of diabetes achieved both with MC and MS Lente insulins was rated as good. There was no ketosis or severe hypoglycaemia, and the daily insulin requirement was reduced in several cases.
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With the technical assistance of B.C. Brossa, A. Bachiorlini, A. Giolitti.
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Bruni, B., D'Alberto, M., Osenda, M. et al. Clinical trial with monocomponent lente insulins. Diabetologia 9, 492–498 (1973). https://doi.org/10.1007/BF00461695
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DOI: https://doi.org/10.1007/BF00461695