This poster gives an overview of the ONWARDS 9 (NCT05823948) trial, a 26-week, treat-to-target, single-arm, phase 3b study designed to explore the effect of continuous glucose monitoring (CGM)-based titration of once-weekly insulin icodec (icodec) on glycemic control and safety outcomes in individuals with type 2 diabetes (T2D).
Methods: Insulin-naïve adults (n=51) with T2D (HbA1c 7.0–11.0%) initiated icodec treatment with 70 units once weekly and thereafter titrated weekly based on CGM values. The primary endpoint was change in HbA1c from week 0 to week 26. CGM metrics were collected throughout the study (weeks −2 to 31), including time in range (TIR; 70–180 mg/dL), time above range (TAR; >180 mg/dL), and time below range (TBR; <54 mg/dL). The number of severe hypoglycemic episodes was also collected through participant reporting.
Results: At week 26, from a mean of 8.18% at week 0, the estimated change in HbA1c was −0.99% points (95% confidence interval: −1.17; −0.81, p <0.0001). From week −2–0 to week 22–26, observed mean TIR increased from 54.36% to 76.38%, mean TAR reduced from 45.16% to 22.90%, while mean TBR was 0.03% at weeks −2–0 and 0.04% at weeks 22–26. No severe hypoglycemic episodes were reported during the study.
Conclusions: From week 0 to week 26, there was a statistically significant reduction in HbA1c. A concomitant clinically meaningful increase in TIR and decrease in TAR was observed, while TBR remained very low with no episodes of severe hypoglycemia reported throughout the study. The internationally recommended CGM targets for TIR, TBR <54 mg/dL, and TAR>180 mg/dL were achieved. These findings suggest that CGM-based titration of icodec is feasible in adults with T2D.
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