An exploratory analysis of the ONWARDS 1 trial, published in The Lancet, assessed continuous glucose monitoring (CGM)-based metrics and hypoglycemia duration in insulin-naive individuals with type 2 diabetes treated with subcutaneous once-weekly insulin icodec (icodec) versus once-daily insulin glargine U100 (glargine U100).

      The ONWARDS 1 trial was a 78-week, randomized, open-label, treat-to-target, phase 3a study conducted at 143 sites across 12 countries. Adults aged ≥18 years with type 2 diabetes and an HbA1c of 7.0–11.0%, who were insulin-naive, were randomly assigned (1:1) via an interactive web-response system to once-weekly icodec or once-daily glargine U100. Double-masked CGM data were collected at multiple time points: during treatment initiation (weeks 0–4), mid-trial (weeks 22–26), end of the main phase (weeks 48–52), end of the extension phase (weeks 74–78), and follow-up (weeks 78–83). Secondary and exploratory outcomes included CGM-based metrics such as the mean percentages of time in range (TIR), time in tight range (TITR), time above range (TAR), time below range (TBR), and hypoglycemic episode duration.

      During treatment initiation, no statistically significant differences were observed in the mean percentages of TIR, TITR, TAR, or TBR between icodec and glargine U100. However, during the mid-trial, end of the main phase, and end of the extension phase, the mean percentages of TIR and TITR were significantly greater, and TAR was significantly lower, with icodec compared to glargine U100. Notably, icodec achieved the internationally recommended CGM target for TIR (>70%) during these periods, whereas glargine U100 did not. TBR remained low and within recommended targets across all study periods for both treatment groups, with no statistically significant differences observed between them for the lower threshold.

      During the follow-up period, the mean percentages of TIR, TITR, TAR, and TBR did not show statistically significant differences between icodec and glargine U100. The duration of overall hypoglycemic episodes was similar across both treatment groups throughout the trial.

      In summary, findings from the CGM data support the long-term efficacy and safety of once-weekly insulin icodec compared to once-daily insulin glargine U100 in insulin-naive individuals with type 2 diabetes. The study also indicated no increase in the duration of hypoglycemic episodes with icodec, reinforcing its potential as a safe and effective treatment option.

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