Superior glycaemic control with once‐daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial

Aims This phase 3, 26‐week, open‐label, treat‐to‐target trial investigated the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in insulin‐naïve Japanese adults with type 2 diabetes. Methods Subjects were randomized to once‐daily injections of IDegAsp (n = 147) or insulin glargine (IGlar) (n = 149), both ±≤2 oral antidiabetic treatments. IDegAsp was given before the largest meal at the discretion of each subject (and maintained throughout the trial); IGlar was dosed according to label. Both insulins were titrated to a target prebreakfast self‐measured plasma glucose of 3.9 to <5.0 mmol/l. Results After 26 weeks, mean HbA1c was 7% with IDegAsp and 7.3% with IGlar; superiority of IDegAsp to IGlar was shown (estimated treatment difference, ETD; IDegAsp–IGlar: –0.28% points [−0.46; –0.10] 95% CI , p < 0.01). At end‐of‐trial, mean fasting plasma glucose ( FPG ) was similar for IDegAsp and IGlar (5.7 vs. 5.6 mmol/l; ETD IDegAsp–IGlar: 0.15 mmol/l [−0.29; 0.60] 95% CI , p = NS). IDegAsp was associated with numerically lower rates of overall confirmed (27%) and nocturnal confirmed hypoglycaemia (25%) versus IGlar (estimated rate ratio IDegAsp/IGlar: 0.73 [0.50; 1.08] 95% CI , p = NS, and 0.75 [0.34; 1.64] 95% CI , p = NS, respectively). Mean daily insulin doses were similar between groups at end‐of‐trial (both: 0.41 U/kg) as were the increases in body weight from baseline (both: 0.7 kg). Adverse event profiles were similar between groups. Conclusions IDegAsp provided superior long‐term glycaemic control compared to IGlar, with similar FPG and doses and numerically lower rates of overall and nocturnal hypoglycaemia (p = NS).