Novo Nordisk's Diabetes Drug Insulin Degludec/Liraglutide Injection Approved in China

By | Pharma Insights

On October 28, it was reported that China's National Medical Products Administration (NMPA) has approved insulin degludec/liraglutide injection (Nuoyi), developed and manufactured by Novo Nordisk. It is indicated for improving glycemic control in adults with type 2 diabetes mellitus with inadequate blood glucose control, to be used in combination with other oral antidiabetic drugs alongside diet and exercise. According to the press release, Nuoyi is the world's first basal insulin and glucagon-like peptide-1 receptor agonist (GLP-1 RA) combination injection.

In this novel antidiabetic drug, liraglutide is a once-daily injectable GLP-1 analog that shares 97% homology with naturally occurring human GLP-1. Like human GLP-1, liraglutide stimulates insulin secretion and suppresses glucagon secretion in a glucose-dependent manner, and promotes weight loss and reduces body fat content through mechanisms that enhance satiety and decrease energy intake.

Another key component of this new drug—insulin degludec—is a next-generation ultra-long-acting basal insulin analog, characterized by its ability to provide steady, safe, and effective glycemic control. It is reported that insulin degludec, developed by Novo Nordisk, offers an ultra-long duration of action of up to 42 hours, granting patients the convenience of flexible injection timing as needed.

According to the press release, insulin degludec/liraglutide injection represents a breakthrough by integrating the dual-component advantages of both drugs with complementary mechanisms of action, simultaneously targeting multiple pathophysiological mechanisms of type 2 diabetes. This once-daily injectable delivers potent 24-hour glycemic control, achieves an HbA1c target attainment rate of up to 89.9%, reduces the risk of hypoglycemia, and demonstrates clear weight benefits.

According to publicly available information, as early as 2014, insulin degludec/liraglutide injection (generic name: IDegLira; international brand name: Xultophy) was approved for marketing in the European Union, becoming the world's first approved combination injection of basal insulin and a GLP-1 receptor agonist (GLP-1RA). In 2016, the drug also received approval from the U.S. FDA for patients with type 2 diabetes whose blood glucose is not adequately controlled with insulin or GLP-1 analogues alone.

At the European Association for the Study of Diabetes (EASD) Annual Meeting in September 2020, the results of the DUAL I/II China study, conducted by Chinese researchers in Chinese patients with type 2 diabetes mellitus with inadequate glycemic control on oral glucose-lowering drugs or basal insulin, were presented.

The DUAL Ⅰ China study demonstrated that insulin degludec/liraglutide injection effectively reduces glycated hemoglobin (HbA1c) with a low risk of hypoglycemia; compared with the control group, patients in the combination therapy group experienced less weight gain and required a lower daily insulin dose. The DUAL Ⅱ China study demonstrated that, compared with the comparator, the combination therapy achieved superior glycemic control, with more patients achieving HbA1c < 7% without hypoglycemia and/or weight gain, along with a lower daily insulin dose. The results of both studies were consistent with those of the global Phase 3 DUAL clinical trial program.

Type 2 diabetes is a chronic metabolic disease that accounts for the vast majority of diabetes cases. The primary manifestation in these patients is insulin resistance, characterized by near-normal circulating insulin levels alongside a diminished physiological response, which results in hyperglycemia and the development of the disease. For these patients, insulin monotherapy often yields suboptimal therapeutic outcomes. As the condition progresses, clinical management frequently necessitates combination therapy with other antidiabetic medications.

The introduction of Novo Nordisk’s insulin degludec and liraglutide injection is expected to bring new treatment options and clinical benefits to patients with type 2 diabetes. Congratulations to Novo Nordisk on the marketing approval of another novel diabetes medication in China.

References:

[1] EU Approves Diabetes Combination Product Xultophy for Marketing [J]. World Clinical Drugs, 2014, 35(274): 90-91.

[2]【New Product Release: Insulin Degludec/Liraglutide Injection】Major Chinese Data on IDegLira Released. Retrieved Dec 23, 2021, from https://mp.weixin.qq.com/s/VMlDNvpmj7TsE4emMjgKLA

[3]【New Product Update: Insulin Degludec/Liraglutide Injection】Latest China Data on IDegLira Released. Retrieved Jan 27, 2021, from https://mp.weixin.qq.com/s/scnvrOCe03BhGsJRQiEJiw

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