Safety of insulin lispro: Pooled data from clinical trials

The safety of insulin lispro was compared with that of regular human insuli n of recombinant DNA origin (Humulin R, Lilly), with special emphasis on th e development and progression of the chronic complications of diabetes mell itus in relation to insulin therapy. Ten clinical trials of 3634 patients with type 1 and type 2 diabetes mellit us were analyzed. The primary focus was treatment-emergent adverse events, and the secondary focus was the development and progression of the chronic complications of diabetes. The evaluations were based on pertinent laborato ry values, predetermined disease-specific COSTART (coding symbol and thesau rus for adverse event terminology) terms, physician evaluations of patients , and physical examinations. There were no clinically or statistically significant differences in the fr equency of treatment-emergent adverse events or progression of retinopathy, neuropathy, or cardiovascular disease reported with each therapy. There wa s no difference between insulin lispro and Humulin R in the occurrence and progression of kidney disease as measured by changes in serum creatinine le vels. Pooled data from clinical studies show that insulin lispro has a safety pro file comparable to that of Humulin R.