Background: This post hoc analysis assessed continuous glucose monitoring (CGM)-based metrics with basal insulin icodec (icodec) versus once-daily (OD) comparators in insulin-naive and insulin-experienced Japanese individuals from the global, phase 3a ONWARDS 1, 2, and 4 trials. Methods: Double-blinded CGM data were collected from Japanese adults (aged ≥20 years) with type 2 diabetes (T2D) during prespecified assessment periods (weeks 0–4 ONWARDS 1, 2, and 4, weeks 22–26 ONWARDS 1, 2, and 4, weeks 48–52 ONWARDS 1, and weeks 74–78 ONWARDS 1). For all assessment periods, percentages of time in range (TIR; sensor glucose SG 70–180 mg/dL), time above range (TAR; SG >180 mg/dL and >250 mg/dL), and time below range (TBR; SG 70% TIR was numerically higher with icodec versus OD comparator during all assessment periods; the opposite was observed in ONWARDS 2 and 4. TBR (SG <70 mg/dL and <54 mg/dL) remained below the recommended targets (<4% and <1%). Across trials, in both arms, the median duration of overall hypoglycemic episodes was ≤45 min; most hypoglycemic episodes included no level 2 hypoglycemic periods (SG <54 mg/dL for ≥15 min). Conclusions: In Japanese individuals with T2D, CGM-based metrics were similar for icodec and OD comparators. Overall duration of hypoglycemic episodes was ≤45 min for icodec and OD comparators and most hypoglycemic episodes included no or <15 min with SG <54 mg/dL. These data support icodec use across the spectrum of T2D in Japan.
Nishimura et al. (2026) studied this question.