(DCP070) BETTER GLYCEMIC CONTROL WITH ONCE-WEEKLY INSULIN ICODEC VERSUS ONCE-DAILY INSULIN DEGLUDEC IN INSULIN-NAÏVE TYPE 2 DIABETES (ONWARDS 3)

Background: The efficacy and safety of once-weekly insulin icodec (icodec) versus once-daily insulin degludec (degludec) in adults with insulin-naïve type 2 diabetes were examined in ONWARDS 3 (NCT04795531), a 26-week, randomized, double-blind, double-dummy, treat-to-target, phase 3a trial.

METHODS AND RESULTS: Participants (n=588) were randomized 1:1 to icodec or degludec. Key outcomes are shown in the table. The primary endpoint was A1C change from baseline to week 26. Estimated mean A1C change from baseline was greater with icodec (−1.57%-points; baseline: 8.55%) versus degludec (−1.36%-points; baseline: 8.48%); estimated treatment difference −0.21%-points (95% confidence interval −0.34, −0.08), confirming non-inferiority (p < 0.0001) and superiority (p=0.0016) of icodec versus degludec. Level 2 or 3 hypoglycemia rates were numerically but not statistically significantly higher with icodec versus degludec in the on-treatment period (table). The odds of achieving A1C < 7% without level 2 or 3 hypoglycemia were statistically significantly higher with icodec versus degludec. There were no significant differences in mean weekly insulin dose from week 24 to 26 or mean body weight change from baseline to week 26 between arms. No unexpected safety findings were observed.

Conclusion: Overall, once-weekly icodec demonstrated superior A1C reduction versus once-daily degludec with low level 2 or 3 hypoglycemia rates in both arms. Icodec may facilitate basal insulin treatment acceptance and adherence by reducing the number of basal insulin injections from ≥365 to 52 per year.