Short Report: Treatment 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 â Basal–Bolus Type 1): 2-year results of a randomized clinical trial B. W. Bode 1 , J. B. Buse 2 , M. Fisher 3 , S. K. Garg 4 , M. Marre 5 , L. Merker 6 , E. Renard 7 , D. L. Russell-Jones 8 , C. T. Hansen 9 , A. Rana 9 and S. R. Heller 10 on behalf of the BEGIN â Basal–Bolus Type 1 Trial Investigators* 1 Atlanta Diabetes Associates, Atlanta, GA, USA, 2 University of North Carolina School of Medicine, Chapel Hill, NC, USA, 3 Glasgow Royal Infirmary, Glasgow, UK, 4 Barbara Davis Center for Childhood Diabetes, Aurora, CO, USA, 5 Bichat Claude Bernard Hospital, Paris, France, 6 Diabetes und Nierenzentrum, Dormagen, Germany, 7 Montpellier University Hospital, Montpellier, France, 8 Royal Surrey County Hospital, Guildford, UK, 9 Novo Nordisk A/S, Søborg, Denmark and 10 University of Sheffield, Sheffield, UK Accepted 22 May 2013 Abstract 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 < 0.01). Conclusions Long-term basal therapy using insulin degludec in Type 1 diabetes required lower doses and was associated with a 25% lower risk for nocturnal hypoglycaemia than insulin glargine. Diabet. Med. 30, 1293–1297 (2013) Introduction New, long-acting basal insulin analogues with more predict- able pharmacodynamics may lower the risk of hypoglycaemia over that of the current marketed insulin analogues insulin glargine and insulin detemir [1]. Insulin degludec is a basal insulin analogue (approved thus far in Europe, Japan, Mexico and other regions) with a half-life of 24 h. In contrast, insulin glargine has a half-life of 12 h and a greater glucose-lowering effect during the first 12 h after injection compared with the subsequent 12 h. The flat insulin-action curve and 4-fold lower variability of insulin degludec [2] result in similar efficacy, but lower risk of hypoglycaemia with insulin degludec than with insulin glargine [3]. Risk reduction in nocturnal hypoglycaemia with insulin degludec was demon- strated in a 52-week, randomized, head-to-head comparison (BEGIN â Basal–Bolus Type 1; hereafter, BEGIN) of once-- daily insulin degludec and insulin glargine, both with meal- time insulin aspart, in Type 1 diabetes [4]. This paper describes a 52-week extension to the BEGIN main trial and assesses the long-term safety and efficacy of insulin degludec in the same population. Correspondence to: Bruce W. Bode. E-mail: bbode001@aol.com *A complete list of the study investigators is presented in the Supporting Information (Appendix S1). This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. ª 2013 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK. 1293 DIABETICMedicine DOI: 10.1111/dme.12243