Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN® Basal-Bolus Type 1): 2-year results of a randomized clinical trial

Aims The goal of this study was to compare the long‐term safety and efficacy of the basal insulin analogue, insulin degludec with insulin glargine (both with insulin aspart) in Type 1 diabetes, over a 2‐year time period. Methods This open‐label trial comprised a 1‐year main trial and a 1‐year extension. Patients were randomized to once‐daily insulin degludec or insulin glargine and titrated to pre‐breakfast plasma glucose values of 3.9–4.9 mmol/l. Results The rate of nocturnal confirmed hypoglycaemia was 25% lower with insulin degludec than with insulin glargine (P = 0.02). Rates of confirmed hypoglycaemia, severe hypoglycaemia and adverse events, and reductions in glycated haemoglobin and fasting plasma glucose were similar between groups. Despite achieving similar glycaemic control, insulin degludec‐treated patients used 12% less basal and 9% less total daily insulin than did insulin glargine‐treated patients (P