Continuous Glucose Monitoring-Based Metrics and Hypoglycemia Duration in Insulin-Experienced Individuals With Long-Standing Type 2 Diabetes Switched From a Daily Basal Insulin to Once-Weekly Insulin Icodec: Post Hoc Analysis of ONWARDS 2 and ONWARDS 4

OBJECTIVE This post hoc analysis assessed continuous glucose monitoring (CGM)-based metrics and hypoglycemia duration with once-weekly insulin icodec (icodec) versus once-daily basal insulin analogs in insulin-experienced individuals with long-standing type 2 diabetes, from two 26-week phase 3a trials (ONWARDS 2 and ONWARDS 4). RESEARCH DESIGN AND METHODS Time in range (TIR; 3.9–10.0 mmol/L), time above range (TAR; >10.0 mmol/L), and time below range (TBR; <3.9 mmol/L and <3.0 mmol/L) were assessed during three CGM time periods (switch [weeks 0–4], end of treatment [weeks 22–26], and follow-up [weeks 27–31]) for icodec versus comparators (ONWARDS 2: insulin degludec [basal regimen]; ONWARDS 4: insulin glargine U100 [basal-bolus regimen]) using double-blinded CGM data. CGM-derived hypoglycemic episode duration (<3.9 mmol/L) was assessed. RESULTS In both trials, there were no statistically significant differences in TIR, TAR or TBR (<3.0 mmol/L) for icodec versus comparators across all time periods. In the end of treatment period, mean TIR was 63.1% (icodec) versus 59.5% (degludec) in ONWARDS 2 and 66.9% (icodec) versus 66.4% (glargine U100) in ONWARDS 4. Mean TBR <3.9 mmol/L and <3.0 mmol/L remained within recommended targets (<4% and <1%, respectively), across time periods and treatment arms. Hypoglycemic episode duration (<3.9 mmol/L) was comparable across time periods and treatment arms (median duration ≤40 min). CONCLUSIONS In insulin-experienced participants with long-standing type 2 diabetes, CGM-based TIR, TAR, and CGM-derived hypoglycemia duration (<3.9 mmol/L) were comparable for icodec and once-daily basal insulin analogs during all time periods; TBR remained within recommended targets.