Novo Nordisk Submits Clinical Application in China for Once-Weekly Icodec Insulin

On September 21, Novo Nordisk’s clinical trial application for icodec insulin injection submitted in China was accepted by the Center for Drug Evaluation (CDE). This is a once-weekly basal insulin analog.

Results from a Phase II clinical trial demonstrated that insulin icodec was comparable to once-daily insulin glargine U100 in terms of glycemic control and safety profile in adults with type 2 diabetes. This 26-week study enrolled 247 adult patients with type 2 diabetes who were insulin-naïve and had inadequate glycemic control with metformin, with or without a DPP-4 inhibitor. The study aimed to compare the efficacy and safety of once-weekly insulin icodec versus once-daily insulin glargine U100. The primary endpoint was the change in HbA1c from baseline to week 26. Secondary endpoints included the change in fasting plasma glucose from baseline to week 26 and the number of hypoglycemic events.

The results showed that from baseline to Week 26, the change in glycemic control (HbA1c) among participants receiving once-weekly insulin icodec was similar to that among participants receiving once-daily insulin glargine U100 (-1.33% vs -1.15%, p=0.08), thereby meeting the primary endpoint. Secondary endpoints included the change in fasting plasma glucose from baseline to Week 26, which was similar between the insulin icodec and insulin glargine U100 groups (-58 mg/dL and -54 mg/dL, respectively); however, for the mean change in 9-point self-monitored blood glucose (SMBG) from baseline to Week 26, insulin icodec demonstrated a greater reduction (-7.9 mg/dL; p=0.01).

In terms of safety, the incidence of hypoglycemia was similar between the two treatment groups, and no new safety issues related to insulin icodec were identified.

Insulin icodec is an investigational long-acting basal insulin analog with a half-life of 196 hours. After injection into the human body, insulin icodec binds tightly but reversibly to albumin. This mechanism enables continuous, slow, and stable glucose-lowering effects over the course of a week. Due to its concentrated formulation, the once-weekly dosing of insulin icodec is comparable to the once-daily dosing of insulin glargine U100.