Efficacy and safety of once‐weekly insulin icodec versus once‐daily basal insulin in Japanese individuals with type 2 diabetes: A subgroup analysis of the ONWARDS 1, 2 and 4 trials.

Aim: To explore the efficacy and safety of once‐weekly insulin icodec (icodec) in Japanese adults (≥20 years old) with type 2 diabetes from the global ONWARDS 1, 2 and 4 trials. Materials and Methods: Insulin‐naive (ONWARDS 1) and insulin‐experienced (ONWARDS 2 and 4) individuals were randomized to icodec or a once‐daily insulin comparator: insulin glargine U100 [ONWARDS 1 (basal insulin only) and 4 (basal–bolus regimen)] or insulin degludec [ONWARDS 2 (basal insulin only)]. The primary outcome was change in glycated haemoglobin from baseline to end of treatment (EOT) (ONWARDS 1: Week 52; ONWARDS 2 and 4: Week 26). Here, we present the Japanese subgroup results. Results: Similar reductions in glycated haemoglobin from baseline to EOT were observed in each trial for icodec and comparators. The proportion of time in range (blood glucose 3.9–10.0 mmol/L) at EOT was also comparable across treatment groups (time in range: 58%–68%), as was time spent with blood glucose below 3.0 mmol/L (<1.0%). Combined clinically significant (blood glucose <3.0 mmol/L) or severe (requiring external assistance for recovery) hypoglycaemia rates were low, with no severe events (ONWARDS 1 and 2) or a single severe event (ONWARDS 4; icodec group) reported. These results generally aligned with findings from the respective global populations. No new safety issues were identified. Conclusions: Icodec improved glycaemic control to a similar degree as once‐daily basal insulin comparators while maintaining low levels of clinically significant or severe hypoglycaemia. The findings support icodec use in Japanese individuals with different levels of type 2 diabetes progression. [ABSTRACT FROM AUTHOR]