Type 2 diabetes is a prevalent chronic condition that requires careful management to achieve optimal glycemic control. Current treatment guidelines recommend a stepwise approach, with incretin-based therapies as the first-line injectable treatments. However, in many cases, initiation of once- or twice-daily basal insulin analogues remains a common strategy to aid in glycemic control.
Unfortunately, concerns surrounding daily injections often lead to reduced treatment adherence, contributing to suboptimal glycemic control for many individuals with type 2 diabetes. According to the New England Journal of Medicine, the results of the ONWARDS 1 trial, the longest trial in the ONWARDS development program for insulin icodec, have been revealed.
This trial focused on evaluating the efficacy and safety of once-weekly insulin icodec compared to once-daily insulin glargine U100 in individuals with type 2 diabetes who had not previously received insulin. The trial demonstrated that the once-weekly insulin regimen with icodec facilitated the initiation of basal insulin treatment and significantly improved glycemic control. Notably, the reduction in glycated hemoglobin levels achieved with icodec was maintained up to week 78.
While a slight further reduction in glycated hemoglobin levels with glargine U100 led to the nonsignificance of the between-group difference at week 78, participants on icodec spent significantly more time within the target glycemic range during specific trial phases. This finding aligns with the International Consensus on Time in Range recommendation of more than 70% of continuous glucose monitoring measurements falling within the target glycemic range. Â
Throughout the trial, both groups experienced low rates of clinically significant or severe hypoglycemic episodes, and the overall rates remained below one event per person-year of exposure. Additionally, the incidence of clinically significant episodes was similar in the icodec group and the glargine U100 group.
The trial had some limitations, including the lack of a double-blind, double-dummy design due to the long duration of the trial and the blinding of glucose measurements, which prevented their use for insulin dose adjustments. However, the trial’s strengths included its long duration, safety follow-up, and a diverse multinational cohort of participants, representing those for whom insulin treatment is warranted despite the availability of newer noninsulin glucose-lowering treatments. Â
In conclusion, the findings of the ONWARDS 1 trial highlight the effectiveness of once-weekly insulin icodec in improving glycemic control compared to once-daily insulin glargine U100 in individuals with type 2 diabetes who had not previously received insulin. The study’s outcomes suggest that icodec offers a promising treatment option that reduces the burden of insulin injections and enhances glycemic management for individuals living with type 2 diabetes.Â
