Abstract
In a randomized multicenter open-label parallel group trial, we compared insulin detemir (detemir) treatment efficacy and safety to NPH insulin (NPH) in subjects with diabetes mellitus requiring insulin in a basal-bolus regimen. We evaluated night-time QOL and treatment satisfaction using Insulin Therapy Related Quality-of-Life at Night (ITR-QOLN) and the Insulin Treatment Satisfaction Questionnaire Japan (ITSQ-J). For ITR-QOLN analysis, the total score in the detemir group with any type of diabetes was higher than the baseline throughout the assessment period. In type 1 diabetes, the total score at 48 weeks in the detemir group was significantly higher than that in the NPH group(p=0.03). For ITSQ-J analysis, the total score in the detemir group was maintained throughout the assessment period compared to the baseline in those with type 1 diabetes, and a higher score was seen in patients with type 2 diabetes. In type 1 diabetes, the total score at 48 weeks in the detemir group was significantly higher than that in the NPH group (p=0.04). Our results suggest that detemir may improve night-time QOL and increase treatment satisfaction due to detemir's decreased hypoglycemia risk.
