Novo Nordisk's Once-Weekly Insulin Icodec Granted Clinical Trial Approval in China

Latest Announcement from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration: Novo Nordisk’s Weekly Insulin Formulation, Icodec Insulin Injection, Approved for Clinical Trials in China, Intended for the Treatment of Diabetes. According to Public Information, This Is an Investigational Long-Acting Basal Insulin Analog with a Half-Life of Approximately One Week.

Screenshot source: CDE official website

According to a recent interview conducted by the WuXi AppTec content team with Professor Mads Krogsgaard Thomsen, Global Executive Vice President and Chief Scientific Officer at Novo Nordisk, the company is working to achieve simultaneous launch of insulin icodec in China and globally. Currently, this investigational drug is undergoing global Phase 3 clinical trials, and China is poised to join these global Phase 3 trials shortly.

This long-acting insulin holds significant importance for patients with diabetes. As we know, many patients with type 2 diabetes who require insulin therapy often need to administer at least one injection per day, and in some cases, up to 2–4 injections daily. They may also need to combine insulin with oral medications, which entails a complex treatment regimen and self-management of blood glucose levels.

To this end, scientists at Novo Nordisk developed icodec by modifying 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 delivers a dose equivalent to seven days of daily injections of insulin glargine U100.

At the 56th Annual Meeting of the European Association for the Study of Diabetes (EASD) in 2020, Novo Nordisk announced the results of the Phase 2 clinical trial of insulin icodec. A total of 154 patients participated in this 16-week trial, all of whom were adult patients with type 2 diabetes who had been using oral antidiabetic drugs but had poor symptom control.

The results demonstrated that insulin icodec exhibited favorable efficacy and tolerability compared with once-daily insulin glargine U100. Switching patients from once- or twice-daily basal insulin to once-weekly insulin icodec did not increase the risk of severe hypoglycemia. Furthermore, 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 the target within the specified time frame was 73%, significantly higher than that in the insulin glargine U100 group (65%).

Another phase 2 clinical trial published in the New England Journal of Medicine showed that the glucose-lowering efficacy and safety of icodec insulin in adult patients with type 2 diabetes who were not previously treated with insulin were similar to those observed in patients receiving once-daily injections of insulin glargine U100.

Screenshot source: Official website of The New England Journal of Medicine

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Nov 26, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=21#

[2] Phase 2 clinical trials demonstrate the efficacy and tolerability of icodec. Retrieved September 24, 2020, from https://www.prnasia.com/story/292681-1.shtml

Source: Yiyao Guanlan

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