Health status and hypoglycaemia with insulin degludec versus insulin glargine: a 2-year trial in insulin-naïve patients with type 2 diabetes

Insulin degludec (IDeg) is a new basal insulin with an ultra-long and stable glucose-lowering effect. We compared once-daily IDeg and insulin glargine (IGlar), both in combination with metformin ± dipeptidyl peptidase-4 inhibitors, in a 52-week, open-label, treat-to-target trial in patients with type 2 diabetes followed by a 52-week extension trial in which subjects [n = 725/1030 (70.4%)] maintained their initial randomised treatment. Health status was assessed at baseline and 105 weeks using the Short Form-36 (SF-36 v2) questionnaire. SF-36 scores were analysed (ITT population) using anova, with adjustments for covariates. At 105 weeks, the overall physical component score was significantly better with IDeg versus IGlar [treatment contrast (TC): 1.1 (0.1; 2.1)(95%)(CI), p < 0.05]. This was largely because of significantly better physical functioning [TC: 1.1 (0.0; 2.3)(95%)(CI), p < 0.05] and bodily pain sub-domain scores [TC: 1.5 (0.2; 2.9)(95%)(CI), p < 0.05]. Improvements in health status with IDeg compared to IGlar were maintained after 2 years.