Continuous Glucose Monitoring-Based Metrics with Once-Weekly Insulin Icodec Versus Once-Daily Basal Insulins in Japanese Individuals with Type 2 Diabetes: Post Hoc Analysis of ONWARDS 1, 2, and 4

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Abstract
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 mg/dL and <54 mg/dL) were analyzed. Proportions of participants achieving internationally recommended CGM targets were calculated for all assessment periods except weeks 0–4. Duration of overall hypoglycemic episodes (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.

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