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.