LONG-TERM COMPARISON OF HUMAN INSULIN ANALOG B10ASP AND SOLUBLE HUMANINSULIN IN IDDM PATIENTS ON A BASAL BOLUS INSULIN REGIMEN

Recombinant DNA technology allows the production of insulin analogues with faster absorption rates from subcutaneous tissue as compared to s oluble human insulin. The human insulin analogue B10Asp (mono/dimeric) is absorbed twice as fast as soluble human insulin (hexameric). A dou ble blind, randomised crossover study with a 1-month run-in period and two 2-month treatment periods was performed in 21 male insulin-depend ent diabetic (IDDM) patients aged 18-40 years in order to compare the metabolic control obtained with equimolar doses of the analogue B10Asp vs soluble human insulin (Actrapid) given as mealtime insulin and int ermediate acting isophane insulin (Protaphane) at bedtime. At the end of each 2-month study period, the patients were admitted to the metabo lic ward. We found significantly higher plasma insulin/analogue levels after breakfast, lunch and dinner with B10Asp as compared to Actrapid (p < 0.05). The plasma insulin/analogue levels were significantly low er before lunch and dinner with B10Asp as compared to Actrapid (p < 0. 05). Also, the plasma insulin/analogue level tended to be lower at bed time when comparing B10Asp to Actrapid. The 24-h blood glucose profile s showed identical fasting blood glucose, significantly lower blood gl ucose after breakfast with the analogue (p < 0.05), no differences in blood glucose after lunch and dinner but a significantly higher blood glucose at midnight using the analogue (p < 0.05). The overall 24-h me an blood glucose concentrations, the daily insulin dose, HbA(1c), diet , home blood glucose monitoring and frequency of hypoglycaemia were al most identical in the two treatment periods. In conclusion, the overal l glycaemic control remained unchanged and quite good when Actrapid wa s exchanged dose for dose with the insulin analogue B10Asp in IDDM pat ients treated with a basal bolus regime.