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Aims  To evaluate the efficacy and safety of two insulin intensification strategies for patients with type 2 diabetes previously treated with basal insulin – insulin degludec ( IDeg ) and insulin aspart ( IAsp ) – administered as a co‐formulation ( IDegAsp ) or as a basal‐bolus regimen ( IDeg  and  IAsp  in separate injections).    Methods  This 26‐week, open‐label, treat‐to‐target, phase  IIIb , non‐inferiority trial randomized patients (1 : 1) to  IDegAsp  twice daily with main meals (n = 138;  IDegAsp  group) or  IDeg  once daily and  IAsp  2–4 times daily (n = 136;  IDeg + IAsp  group).    Results  After 26 weeks, the mean glycated haemoglobin ( HbA1c ) level was 7.0% (53 mmol/mol) for the  IDegAsp  group and 6.8% (51 mmol/mol) for the  IDeg + IAsp  group (Δ% HbA1c  from baseline −1.31 and −1.50%, respectively). The non‐inferiority of  IDegAsp  versus  IDeg + IAsp  was not confirmed for mean change in  HbA1c  [estimated treatment difference ( ETD ) 0.18, 95% confidence interval ( CI ) −0.04, 0.41; p = non‐significant]. No significant differences were observed in the proportion of patients achieving  HbA1c  <7.0% (56.5 and 59.6%, respectively).  IDegAsp  treatment resulted in a significantly lower total daily insulin dose, a smaller change in body weight, numerically lower rates of confirmed hypoglycaemia (self‐reported plasma glucose <3.1 mmol/l; rate ratio 0.81; p = non‐significant), and nocturnal confirmed hypoglycaemic episodes (rate ratio 0.80; p = non‐significant) versus  IDeg + IAsp . Patient‐reported outcome scores for social functioning were significantly higher for  IDegAsp  versus  IDeg + IAsp  ( ETD  2.2; 95%  CI  0.3, 4.1; p < 0.05).    Conclusions  Both intensification strategies effectively improved glycaemic control. Although non‐inferiority was not confirmed, there were no significant differences between the groups that could affect clinical utility.

diabetes, obesity and metabolism

Treatment intensification with an insulin degludec ( IDeg )/insulin aspart ( IAsp ) co‐formulation twice daily compared with basal  IDeg  and prandial  IAsp  in type 2 diabetes: a randomized, controlled phase  III  trial