Type 2 & other diabetes

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

J Clin Endocrinol MetabPublished Post hoc subgroup analysis of the ONWARDS 1 to 5 phase 3a randomised trials

Authors' conclusion

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

Study context

Population
Insulin-naive (ONWARDS 1, 3, 5) and insulin-experienced (ONWARDS 2, 4) adults (≥18 years) with T2D; subgroups by age (<55, 55–64, ≥65 years), ethnicity (Hispanic/Latino, non-Hispanic/Latino) and race (Asian, Black/African American, White, Other)
Comparison
Once-weekly insulin icodec vs once-daily basal insulin comparators
Primary endpoint
Change in HbA1c from baseline
Follow-up
Planned end of treatment
Methodological detailssubgroup analysis by age, ethnicity and race
  • Subgroup analysis by age, ethnicity and race

Primary result

As reported in the abstract

Change in HbA1c across age, ethnicity and race subgroups
  • Estimated treatment differences for HbA1c change similar across age, ethnicity and race subgroups; no statistically significant treatment by subgroup interactions
  • Icodec vs once-daily (OD) insulin: P > 0.05 in all instances (treatment by subgroup interaction)
  • Post hoc analysis

Further findings

OutcomeP value
HbA1c <7% (<53 mmol/mol) without clinically significant or severe hypoglycemia, across subgroupsSimilar across age, ethnicity and race subgroupsP > 0.05 in all instances (treatment by subgroup interaction)

HbA1c <7% (<53 mmol/mol) without clinically significant or severe hypoglycemia, across subgroups

ORs similar across age, ethnicity and race subgroups

Safety

Clinically significant or severe hypoglycemic episodes

Hypoglycemia rates numerically low for both treatment groups and consistent across age, ethnicity and race subgroups

Original publication

Efficacy and Hypoglycemia Profile of Once-weekly Insulin Icodec vs Once-daily Comparators Across Demographic Subgroups. J Clin Endocrinol Metab. Published 19 March 2025. doi:10.1210/clinem/dgaf168

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