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Aims  To investigate, in a 26‐week, open‐label, randomized, treat‐to‐target trial, the efficacy and safety of insulin degludec/insulin aspart ( ID egAsp) once daily vs insulin glargine ( IG lar) once daily in adults with Type 2 diabetes, inadequately controlled on basal insulin.    Methods  Participants were randomized (1:1) to  ID egAsp once daily or  IG lar once daily in combination with existing oral antidiabetic drugs.  ID egAsp once daily was administered with the main evening meal or the largest meal of the day (agreed at baseline); dosing time was maintained throughout the trial. Participants titrated their insulin dose weekly to a mean pre‐breakfast self‐measured plasma glucose target [3.9–4.9 mmol/l (70–89 mg/dl)].    Results   ID egAsp once daily was non‐inferior to  IG lar once daily in reducing HbA 1c  after 26 weeks [mean estimated treatment difference  ID egAsp once daily −  IG lar once daily: −0.03% (95%  CI  −0.20, 0.14)]. The evening meal glucose increment was significantly lower with  ID egAsp once daily vs  IG lar once daily [estimated treatment difference  ID egAsp once daily −  IG lar once daily: −1.32 mmol/l (95%  CI  −1.93, −0.72);  P  < 0.05]. The overall confirmed hypoglycaemia rate was higher with  ID egAsp once daily (estimated rate ratio 1.43; 95%  CI  1.07, 1.92;  P  < 0.05). The rate of nocturnal hypoglycaemia did not significantly differ between the  ID egAsp and  IG lar groups [estimated rate ratio 0.80 (95%  CI  0.49, 1.30); not significant].    Conclusions  In participants with Type 2 diabetes inadequately controlled on basal insulin,  ID egAsp once daily improved glycaemic control and was non‐inferior to  IG lar once daily.  ID egAsp led to higher rates of overall hypoglycaemia than  IG lar, with no significant difference in rates of nocturnal hypoglycaemia.

diabetic medicine

Efficacy and safety of once‐daily insulin degludec/insulin aspart compared with once‐daily insulin glargine in participants with Type 2 diabetes: a randomized, treat‐to‐target study