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Once-Weekly Insulin Icodec in Basal-Bolus Insulin-Treated Type 2 Diabetes 

Compared with once-daily insulin glargine U100 (glargine) in the phase 3a noninferiority ONWARDS 4 trial, once-weekly insulin icodec (icodec) produced similar improvements in glycemic control with fewer basal insulin injections, lower bolus insulin dose, and no increase in hypoglycemic rates. “Key strengths of this trial include the use of masked continuous glucose monitoring; the high trial completion rate; and the inclusion of a large, diverse, and multinational population,” the authors write. “Limitations include the relatively short trial duration and the open-label design.”

In 9 countries in Europe, Asia, and North America, 582 participants with type 2 diabetes (HbA1c of 7% to 10%) for a mean of 17.1 years received 2–4 daily bolus insulin aspart injections plus either open-label once-weekly icodec or once-daily glargine U100 for 26 weeks. With a primary outcome of change in HbA1c from baseline to week 26 and a noninferiority margin 0.3 percentage points, the investigators found: “At week 26, estimated mean change in HbA1c was −1.16 percentage points in the icodec group (baseline 8.29%) and −1.18 percentage points in the glargine U100 group (baseline 8.31%), showing non-inferiority for icodec versus glargine U100 (estimated treatment difference 0.02 percentage points [95% CI −0.11 to 0.15], P <0.0001). Overall, 171 (59%) of 291 participants in the icodec group and 167 (57%) of 291 participants in the glargine U100 group had an adverse event. 35 serious adverse events were reported in 22 (8%) of 291 participants in the icodec group and 33 serious adverse events were reported in 25 (9%) of 291 participants receiving glargine U100. Overall, combined level 2 and level 3 hypoglycaemia rates were similar between treatment groups. No new safety concerns were identified for icodec.”

Editorial: “These findings would suggest that once-weekly icodec is a viable therapeutic option for people with type 2 diabetes on a basal-bolus insulin regimen, and, perhaps more importantly, heralds the introduction of once-weekly insulins into clinical practice, an exciting and welcome addition to the insulin family,” writes an editorialist.

Source: Lancet