Improved health status with insulin degludec compared with insulin glargine in people with Type1 diabetes

Aims The efficacy and safety of insulin degludec (degludec), a new-generation ultra-long-acting basal insulin, was compared with insulin glargine (glargine) in people with Type1 diabetes mellitus in a 16-week, open-label, randomized trial. Health status, an important aspect of effective diabetes management, was also assessed. Methods Degludec (n=59) or glargine (n=59) were injected once daily, with insulin aspart at mealtimes. Health status assessment utilized the validated Short Form36 Health Survey, version2, which has two summary component scores for mental and physical well-being, each comprising four domains. Results At study end, HbA _1c reductions were comparable between groups, but confirmed nocturnal hypoglycaemia was significantly less frequent with degludec [relative rate0.42 (95%CI 0.25-0.69)], and overall hypoglycaemia numerically less frequent [relative rate0.72 (95%CI 0.52-1.00)]. After 16weeks, a significant improvement in Short Form36 Health Survey mental component score of +3.01 (95% CI 0.32-5.70) was obtained for degludec against glargine, attributable to significant differences in the social functioning [+8.04 (95% CI 1.89-14.18)] and mental health domains [+2.46 (95% CI 0.10-4.82)]. For mental component score, Cohen's effect size was 0.42, indicating a small-to-medium clinically meaningful difference. The physical component score [+0.66 (95% CI -2.30 to 3.62)] and remaining domains were not significantly different between degludec and glargine. Conclusions In the context of comparable overall glycaemic control with glargine, degludec improved mental well-being as measured using the mental component score of the Short Form36 Health Survey. The improvements in overall mental component score and the underlying social functioning and mental health domains with degludec compared with glargine may relate to the observed reduction in hypoglycaemic events.