SAFETY AND EFFICACY OF [LYS(B28),PRO(B29)]-HUMAN INSULIN IN PATIENTS WITH DIABETES-MELLITUS

The primary objectives of this study were to assess the efficacy and s afety of Lys(B28), Pro(B29) in the treatment of patients with diabetes mellitus and to compare Lys(B28), Pro(B29) to currently available reg ular insulin with respect to quality of life. This study was designed as an open-label, non-comparative one. The number of patients enrolled in the trial was 39. At Visit 1 (week 0), blood samples for fasting, 1- and 2-hour postprandial blood glucose, and HbA1c were taken. At Vis it 2 (week 6) and Visit 3 (week 12), fasting, 1- and 2-hour postprandi al blood glucose, and HbAlc levels were measured again. There was no s ignificant change in HbAlc, fasting blood glucose and 1- and 2-hour po stprandial blood glucose levels. The 1- and 2-hour postprandial blood glucose excursions decreased significantly from Visit 1 to Visit 3. Th ere were no serious adverse events during the study. Half of the patie nts had less hypoglycemia with LysPro insulin, while 25% had an increa se in episodes. Thirty percent of patients were more satisfied with Ly sPro insulin than with the short-acting insulin that they had previous ly used. In conclusion, LysPro therapy can be regarded as safe, since there were no unexpected adverse events and no changes in the usual ph ysical parameters.