Insulin degludec improves health-related quality of life (SF-36^®) compared with insulin glargine in people with Type 2 diabetes starting on basal insulin: A meta-analysis of phase 3a trials

Aim: To compare the effect of insulin degludec and insulin glargine on health-related quality of life in patients with Type 2 diabetes starting on insulin therapy. Methods: Patient-level data from three open-label, randomized, treat-to-target trials of 26 or 52 weeks' duration were pooled using a weighted analysis in conjunction with a fixed-effects model. Insulin-naive patients received either insulin degludec (n = 1290) or insulin glargine (n = 632) once daily, in combination with oral anti-diabetic drugs. Glycaemic control was assessed via HbA_1c and fasting plasma glucose concentrations. Rates of hypoglycaemia, defined as plasma glucose < 3.1 mmol/l (< 56 mg/dl), were recorded. Health-related quality of life was evaluated using the 36-item Short Form (SF-36^®) version 2 questionnaire. Statistical analysis was performed using a generalized linear model with treatment, trial, anti-diabetic therapy at baseline, gender, region and age as explanatory variables. Results: Insulin degludec was confirmed as non-inferior to insulin glargine based on HbA_1c concentrations. In each trial comprising the meta-analysis, fasting plasma glucose and confirmed overall and nocturnal (00.01-05.59 h) hypoglycaemia were all numerically or significantly lower with insulin degludec vs. insulin glargine. At endpoint, the overall physical health component score was significantly higher (better) with insulin degludec vs. insulin glargine [+0.66 (95% CI 0.04-1.28)], largely attributable to a difference [+1.10 (95% CI 0.22-1.98)] in the bodily pain domain score. In the mental domains, vitality was significantly higher with insulin degludec vs. insulin glargine [+0.81 (95% CI 0.01-1.59)]. Conclusions: Compared with insulin glargine, insulin degludec leads to improvements in both mental and physical health status for patients with Type 2 diabetes initiating insulin therapy.