A 64-week, double-blind, treat-to-target crossover trial randomised 501 adults with type 1 diabetes (T1D) and ≥ one factor associated with increased risk of developing hypoglycaemia to once-daily insulin degludec (IDeg) or insulin glargine U100 (IGlar U100), both with mealtime insulin aspart for 32 weeks (16-week titration period, 16-week maintenance period), followed by crossover to IGlar U100 or IDeg.
The primary objective was to confirm non-inferiority in the number of severe (requiring third-party aid, all externally adjudicated) or blood glucose (BG)-confirmed (<3.1 mmol/L) symptomatic hypoglycaemic episodes during the maintenance periods. Treatment with IDeg vs. IGlar U100 resulted in significantly lower rates of severe or BG-confirmed symptomatic hypoglycaemia, severe or BG-confirmed symptomatic nocturnal hypoglycaemia (occurring between 00:01 am and 05:59 am), and severe hypoglycaemia for maintenance and total treatment periods (Fig).
IDeg was superior to IGlar U100 regarding a lower proportion of patients experiencing severe hypoglycaemia during maintenance and total treatment periods. HbA1c non-inferiority of IDeg vs. IGlar U100 was confirmed in both treatment periods (means, week 32: 6.95 vs. 6.92%; week 64: 6.95 vs. 6.97%). Adverse event rates were similar for IDeg vs. IGlar U100. In this T1D population, IDeg significantly reduced the rates and proportions of severe hypoglycaemia and the rates of BG-confirmed symptomatic overall and nocturnal hypoglycaemia vs. IGlar U100.