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Aims/Introduction  Insulin degludec/insulin aspart ( ID egAsp) is a soluble combination of insulin degludec (70%) and insulin aspart (30%). The present exploratory trial investigated the safety of switching unit‐to‐unit from twice‐daily basal or pre‐mix insulin to twice‐daily  ID egAsp in Japanese patients with type 2 diabetes.    Materials and Methods  In this 6‐week, open‐label, parallel‐group, controlled trial, 66 participants were randomized (1:1) to receive either  ID egAsp or biphasic insulin aspart 30 ( BIA sp 30) twice daily at the same total daily dose as pre‐trial insulin. During the trial, insulin doses were adjusted according to a pre‐specified algorithm to achieve pre‐breakfast and pre‐dinner plasma glucose of 4.4–7.2 mmol/L.    Results  No severe hypoglycemic episodes occurred. There were no statistically significant differences in rates of confirmed hypoglycemia (rate ratio  ID egAsp/ BIA sp 30: 0.63, 95% confidence interval: 0.31–1.30) and confirmed nocturnal hypoglycemia (rate ratio: 0.49, 95% confidence interval: 0.10–2.38) for  ID egAsp vs  BIA sp 30. The hypoglycemia rate for  ID egAsp was constant over the 6 weeks of treatment.  ID egAsp and  BIA sp 30 were both safe and well tolerated. Reduction in fasting plasma glucose was statistically significantly greater for  ID egAsp than for  BIA sp 30 (estimated treatment difference,  ID egAsp‐ BIA sp 30: −1.6 mmol/L, 95% confidence interval: −2.4 to −0.8). The apparent decrease in mean postprandial plasma glucose increment ( ID egAsp: 4.2–3.8 mmol/L;  BIA sp 30: 4.5–2.8 mmol/L) was not statistically significantly different between treatments (estimated treatment difference: 1.0 mmol/L, 95% confidence interval: −0.1 to 2.2).    Conclusions  Switching unit‐to‐unit from basal or pre‐mix insulin to  ID egAsp seems not to be associated with any concerns related to hypoglycemia or general safety in Japanese patients with type 2 diabetes.

Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial