Lispro insulin as premeal therapy in type 1 diabetes: comparison with Humulin R

Aims, To determine the efficacy, tolerability and safety of the short-acting insulin analogue lispro compared with regular short-acting insulin, Humulin R as premeal therapy in type 1 diabetes mellitus and to assess the safety of lispro administered for one year. Methods. The study was part of an international multicentre crossover study (IOAG) in which 1008 patients were randomised. Twenty patients from Auckland, with insulin dependent diabetes mellitus, received lispro for 3 months and Humulin R for 3 months in a crossover design. At the end of the crossover period, 19 patients elected to participate in an open label continuation of lispro therapy. Humulin N, L or U was used as basal insulin therapy. Results. Lispro and Humulin R in combination with Humulin N, L or U did not significantly differ with respect to glycaemic control or incidence of hypoglycaemia. Glycosylated haemoglobin (HbA(1c)) improved from 8.6% at baseline to 7.6 +/- 0.9 (Humulin R) and 7.7 +/- 1.1% (lispro). During the open label continuation of lispro plus the usual basal insulin HbA(1c) deteriorated to 8.6% after 12 months. Conclusions, In this short-term comparison, lispro and Humulin R were well tolerated, while glycaemic control, incidence of hypoglycaemia and adverse effects were similar.