Comparison of the soluble basal insulin analog insulin detemir with NPH insulin - A randomized open crossover trial in type 1 diabetic subjects on basal-bolus therapy

OBJECTIVE- Insulin detemir (NN304) is a soluble basal insulin analog develo ped to cover basal insulin requirements. This trial aimed to compare the bl ood glucose-lowering effect of insulin detemir with that of NPH insulin (NP H) and to evaluate the two treatments with regard to intrasubject variation of fasting blood glucose, incidence of hypoglycemia, dose requirements. an d safety. RESEARCH DESIGN AND METHODS- This multicenter open randomized crossover tri al in 59 type 1 diabetic subjects comprised a 2-week run-in period on a bas al-bolus regimen with NPH insulin once dairy, followed by two 6-week period s of optimized basal-bolus therapy with either once-daily insulin detemir o r NPH insulin. RESULTS- The area under the curve, in the time interval 23:00-8:00, derived from 24-h serum glucose profiles, nas not statistically significantly diff erent for the two treatment periods (insulin detemir:NPH ratio 89.2:83.5, P = 0.59). The intrasubject variation in fasting blood glucose during the la st 4 days of treatment was lower for insulin detemir compared with NPH (P < 0.001). Mean dose requirements of insulin detemir were 2.35 times higher ( 95% CI 2.22-2.48) compared with NPH. During the last week of treatment, few er subjects experienced hypoglycemic episodes on insulin detemir (60%) comp ared with NPH treatment (77%) (P = 0.049). CONCLUSIONS- Insulin detemir was as effective as NPH in maintaining glycemi c control when administered at a higher molar dose. The results indicate th at insulin detemir may provide more predictable fasting blood glucose with lower intrasubject variation and reduced risk of hypoglycemia compared with NPH.