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AIMS/HYPOTHESIS: Nocturnal hypoglycaemia remains a main limiting factor for achieving the recommended glycaemic target in type 1 diabetes (T1D). The long-acting insulin analogue degludec reduces the risk of nocturnal hypoglycaemia in patients with T1D at low risk of such events. This study investigates whether insulin degludec compared with insulin glargine U100 reduces the risk of nocturnal and severe hypoglycaemia in patients prone to nocturnal severe hypoglycaemia.METHODS: Adults with T1D and at least one episode of nocturnal severe hypoglycaemia during the last two years were included in a two-year prospective, randomised, open, multicentre, cross-over trial. A total of 149 patients were randomised 1:1 to basal-bolus therapy with insulin degludec and insulin aspart or insulin glargine U100 and insulin aspart. Each treatment period was one year long and consisted of three months of run-in or cross-over followed by nine months of maintenance. The primary endpoint was the number of blindly adjudicated nocturnal symptomatic hypoglycaemic episodes. Secondary endpoints included the occurrence of severe hypoglycaemia. We analysed all endpoints by intention-to-treat.RESULTS: Treatment with insulin degludec resulted in a 28% (95%CI: 9-43; p=0.02) relative rate reduction (RRR) of nocturnal symptomatic hypoglycaemia at level 1 (≤3.9 mmol/L), a 37% (95%CI: 16-53; p=0.002) RRR at level 2 (≤3.0 mmol/l), and a 35% (95%CI: 1-58; p=0.04) RRR in all-day severe hypoglycaemia compared to insulin glargine U100.CONCLUSIONS/INTERPRETATION: Patients with T1D prone to nocturnal severe hypoglycaemia have lower rates of nocturnal symptomatic hypoglycaemia and all-day severe hypoglycaemia with insulin degludec as compared with insulin glargine U100. This article is protected by copyright. All rights reserved.