Efficacy and Hypoglycemia Profile of Once-Weekly Insulin Icodec vs. Once-Daily Comparators across Demographic Subgroups.

Abstract

Objective: This post hoc analysis evaluated the impact of age, ethnicity, and race on efficacy and hypoglycemia outcomes with once-weekly insulin icodec (icodec) versus once-daily (OD) basal insulin comparators, leveraging data from the ONWARDS 1-5 phase 3a clinical trials.

Methods: 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.

Results: 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 versus OD insulin (no statistically significant treatment by subgroup interactions were observed; P > 0.05 in all instances). Hypoglycemia rates were numerically low for both treatment groups and consistent across age, ethnicity, and race subgroups.

Conclusion: The efficacy and hypoglycemia profile of icodec versus OD comparators was consistent across trial populations irrespective of age, ethnicity, or race.