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 insu lin, Humulin R as premeal therapy in type 1 diabetes mellitus and to a ssess the safety of lispro administered for one year. Methods. The stu dy was part of an international multicentre crossover study (IOAG) in which 1008 patients were randomised. Twenty patients from Auckland, wi th insulin dependent diabetes mellitus, received lispro for 3 months a nd Humulin R for 3 months in a crossover design. At the end of the cro ssover period, 19 patients elected to participate in an open label con tinuation of lispro therapy. Humulin N, L or U was used as basal insul in therapy. Results. Lispro and Humulin R in combination with Humulin N, L or U did not significantly differ with respect to glycaemic contr ol or incidence of hypoglycaemia. Glycosylated haemoglobin (HbA(1c)) i mproved 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 us ual basal insulin HbA(1c) deteriorated to 8.6% after 12 months. Conclu sions, In this short-term comparison, lispro and Humulin R were well t olerated, while glycaemic control, incidence of hypoglycaemia and adve rse effects were similar.