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

AimsThe 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 Type1 diabetes, over a 2-year time period. MethodsThis 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 3.9-4.9mmol/l. ResultsThe 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<0.01). ConclusionsLong-term basal therapy using insulin degludec in Type1 diabetes required lower doses and was associated with a 25% lower risk for nocturnal hypoglycaemia than insulin glargine. What's new? Insulin degludec is the first basal insulin analogue with an ultra-long duration of action for the treatment of Type1 and Type2 diabetes mellitus. The pharmacokinetic and pharmacodynamic profile of insulin degludec results in similar efficacy but reduces the risk of nocturnal hypoglycaemia compared with currently marketed basal insulins. This multi-centre, multinational, 2-year study reaffirms the long-term safety and efficacy of insulin degludec in patients with Type1 diabetes in a basal-bolus regimen with insulin aspart.