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Aims/Introduction  This trial assessed the efficacy and safety of the possibility of varying the daily injection time of once‐daily, long‐acting basal insulin degludec ( ID eg) in Japanese patients with type 2 diabetes inadequately controlled with insulin glargine.    Materials and Methods  This was a 26‐week, multicenter, open‐label, randomized, treat‐to‐target trial, with a 2 × 2 factorial design comparing  ID eg flexible (allowing dosing ±8 h from an agreed dosing time) with  ID eg fixed dosing (at the same time each day). It was carried out in 458 adult patients who were inadequately controlled on insulin glargine with or without oral antidiabetic drugs.    Results  The majority of doses were taken within 2 h of the agreed dosing time, showing a high level of adherence among Japanese patients. After 26 weeks,  ID eg flexible was non‐inferior to  ID eg fixed with respect to change in glycated hemoglobin from baseline, estimated treatment difference 0.08% points (95% confidence interval −0.05; 0.22). Fasting plasma glucose decreased to a similar level with  ID eg flexible and  ID eg fixed, estimated treatment difference −0.18 mmol/L (95% confidence interval −0.48; 0.12). The rates of confirmed and nocturnal confirmed hypoglycemia were numerically, but not significantly, higher with  ID eg flexible vs  ID eg fixed dosing. The rates of adverse events with  ID eg flexible and  ID eg fixed dosing were similar.    Conclusions  These results showed the efficacy and safety of allowing patients to vary the time they dosed  ID eg, when necessary, in Japanese patients with type 2 diabetes. Dosing of  ID eg at a time convenient to the patient was non‐inferior, with respect to glycated hemoglobin, to dosing at the same time each day.

journal of diabetes investigation

Efficacy and safety of once‐daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26‐week, treat‐to‐target trial