Insulin icodec (Awiqli)

Once-weekly basal insulin analog · insulin class · sc weekly · Novo Nordisk

Top dose
titrated
HbA1c reduction
-1.55%
at week 52 · treatment policy
AE discontinuation
2.0%
Status
approved

Pivotal trial

Trial
ONWARDS-1
Indication
type 2 diabetes (insulin-naive)
Duration
52 weeks
ClinicalTrials.gov
NCT04460885
Sponsor
Novo Nordisk

Notes

ONWARDS-1 (Rosenstock NEJM 2023): once-weekly icodec HbA1c -1.55% vs daily glargine U100 -1.35% in insulin-naive T2D at week 52, baseline 8.5%. The key tolerability axis for insulin is hypoglycemia, not AE-led discontinuation - icodec showed slightly higher level-2/3 hypoglycemia than glargine. Approved EU as Awiqli; first once-weekly basal insulin.

Publication

NEJM 2023 (ONWARDS-1)