Novo Nordisk Initiates Clinical Trial of Once-Weekly Icodec Insulin in China for Type 2 Diabetes

According to the latest announcement on the Chinese Drug Clinical Trial Registration and Information Publicity Platform, Novo Nordisk has initiated a study in China to evaluate the pharmacokinetic characteristics of icodec insulin in subjects with type 2 diabetes. The study aims to assess the retention and changes of icodec insulin in patients' blood over time following injection. According to public information, icodec insulin is an investigational long-acting basal insulin analog with a half-life of approximately one week.

Icodec insulin was developed by scientists at Novo Nordisk through modification of the insulin molecule. After injection, icodec binds firmly and reversibly to albumin, forming a “circulating reservoir” with a half-life of up to 196 hours. This enables the candidate drug to release insulin continuously and steadily, thereby meeting patients’ basal insulin requirements for an entire week. Due to its concentrated formulation, a single injection of icodec is equivalent to daily injections of insulin glargine U100 over the course of one week. The product was approved for clinical trials in China in November 2020 and is intended for the treatment of diabetes.

The clinical study of icodec insulin initiated in China is a single-arm, open-label, Phase I trial investigating the pharmacological effects of the novel long-acting insulin (icodec insulin) in Chinese subjects with type 2 diabetes. The principal investigators are Professor Wang Rui and Dr. Liang Beibei, Deputy Chief Pharmacist, both from the Chinese PLA General Hospital. The study plans to enroll 20 participants in China.

According to the previously announced Phase 2 clinical trial results of insulin icodec by Novo Nordisk, adult patients with type 2 diabetes treated with insulin icodec demonstrated favorable efficacy and tolerability compared to those receiving once-daily injections of insulin glargine U100. Switching from once- or twice-daily basal insulin injections to once-weekly insulin icodec did not increase the risk of severe hypoglycemia. Meanwhile, among patients treated with insulin icodec using a loading dose regimen (administering a higher initial dose to more rapidly achieve steady-state drug concentrations), the proportion achieving target glycemic control was 73%, significantly higher than that in the insulin glargine U100 group (65%).

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