Insulin Icodec is an investigational once-weekly basal insulin analogue for diabetes management. With extensive researches progressing towards identifying an effective lead for diabetes management, a recent research published in ‘The New England Journal of Medicine’ conducted a 78-week randomized, open-label, treat-to-target phase 3a trial (including a 52-week main phase and a 26-week extension phase, plus a 5-week follow-up period) involving adults with type 2 diabetes with an HbA1c of 7 - 11% and had not previously received insulin.

      Participants were randomly assigned in a 1:1 ratio to receive once-weekly insulin Icodec or once-daily insulin Glargine U100. The primary end point was the change in the HbA1c level from baseline to week 52; the confirmatory secondary end point was the percentage of time spent in the glycemic range of 70 -180 mg/dL in weeks 48 to 52. Hypoglycemic episodes (from baseline to weeks 52 and 83) were recorded.

      The results of the study revealed similar baseline characteristics in the two groups. The mean reduction in HbA1c level at 52 weeks was greater with Icodec than with Glargine U100 (from 8.50% to 6.93% with Icodec and from 8.44% to 7.12% with Glargine U100 confirmed the noninferiority (P<0.001) (P=0.02) of Icodec. The percentage of time spent in the glycemic range of 70-180 mg/dL was significantly higher with Icodec than with Glargine U100 (71.9% vs. 66.9%; [95% CI, 1.92 to 6.62]; P<0.001), which again confirmed Icodeg’s superiority over Glargine. Rates of combined clinically significant or severe hypoglycemia were 0.30 events per person-year of exposure with Icodec and 0.16 events per person-year of exposure with Glargine U100 at week 52.

      According to the research team, glycemic control was significantly better with once-weekly insulin Icodec than with once-daily insulin Glargine U100.