1. At 26 weeks, the mean change in HbA1c was comparable between the weekly insulin icodec and daily glargine U100 groups.
2. There was no significant difference in serious adverse events or hypoglycemic episodes between treatment groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: A basal-bolus insulin regimen is often required for glycemic control in patients with type 2 diabetes. However, the number of injections required may lead to issues with adherence. Insulin icodec is a novel basal insulin analogue that may be used in such patients, although evidence around its clinical efficacy is limited. This randomized controlled trial aimed to compare the safety and efficacy of once-weekly icodec versus once-weekly insulin glargine U100 (glargine U100) in patients with type 2 diabetes on basal-bolus insulin regimen. The primary outcome was a change in HbA1c from baseline to 26 weeks, while key secondary outcomes included rate of adverse events and hypoglycemia. According to study results, once weekly icodec was non-inferior to glargine U100 in safety and efficacy and required fewer basal injections with lower bolus insulin doses. This study was strengthened by a randomized design with patients from multiple countries, thus adding to its generalizability.
In-depth [randomized-controlled trial]: Between May 14 and Oct 29, 2021, 746 patients were screened for eligibility from 80 sites across 9 countries. Included were patients ≥ 18 years with uncontrolled type 2 diabetes on basal-bolus insulin regimen and HbA1c between 7.0-10.0%. Altogether, 582 patients (291 each in icodec and glargine U100) were included in the final analysis. The primary outcome of mean change in HbA1c was comparable in the icodec (-1.16%) and glargine U100 (-1.18%) groups (95% confidence interval [CI] -0.11 to 0.15, p<0.0001 for noninferiority). Similarly, the proportion of patients in either group with overall adverse events (59% icodec vs. 57% glargine U100), serious adverse events (8% icodec vs. 9% glargine U100), and level 2 and 3 hypoglycemia were comparable. Findings from this study suggest that once-weekly icodec is non-inferior to once-daily glargine U100 with fewer basal injections needed.
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