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

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.

Figure 1

Safety and efficacy of long-term use of insulin degludec measured in terms of (a) nocturnal confirmed hypoglycaemia over the treatment period (safety analysis set), (b) overall confirmed hypoglycaemia over the treatment period (safety analysis set), (c) HbA_1c values over time (full analysis set), (d) 9-point self-measured plasma glucose values over time (full analysis set) and (e) insulin dose over time (safety analysis set). The efficacy parameters are presented as the mean (se; represented by error bars). The full analysis set consisted of all randomly assigned participants. The safety analysis set consisted of all participants who had been exposed to the trial drug. Missing data were imputed using the last-observation-carried-forward approach.