Efficacy and Hypoglycemia Profile of Once-weekly Insulin Icodec vs Once-daily Comparators Across Demographic Subgroups.

Abstract

This post hoc analysis evaluated the impact of age, ethnicity, and race on efficacy and hypoglycemia outcomes with once-weekly insulin icodec (icodec) vs once-daily (OD) basal insulin comparators, leveraging data from the ONWARDS 1 to 5 phase 3a clinical trials. Efficacy and hypoglycemia outcomes were assessed within each trial in insulin-naive (ONWARDS 1, 3, and 5) and insulin-experienced (ONWARDS 2 and 4) adults (≥18 years) with type 2 diabetes across subgroups of age (<55, 55-64, and ≥65 years), ethnicity (Hispanic/Latino and non-Hispanic/Latino), and race (Asian, Black/African American, White, Other). The primary outcome was the change in glycated hemoglobin (HbA1c) from baseline to planned end of treatment. Other outcomes assessed included the achievement of HbA1c <7% (<53 mmol/mol) without clinically significant or severe hypoglycemia and the number of clinically significant or severe hypoglycemic episodes. Across all trials, the estimated treatment differences for change in HbA1c and the odds ratios for achieving HbA1c <7% (<53 mmol/mol) without clinically significant or severe hypoglycemia were similar across age, ethnicity, and race subgroups with icodec vs OD insulin (no statistically significant treatment by subgroup interactions were observed; P > .05 in all instances). Hypoglycemia rates were numerically low for both treatment groups and consistent across age, ethnicity, and race subgroups. The efficacy and hypoglycemia profile of icodec vs OD comparators was consistent across trial populations irrespective of age, ethnicity, or race.