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On October 28th, China’s National Food and Drug Administration (NMPA) has approved Novo Nordisk's research and development and production of insulin deglubber and liraglutide injection (Novo Nordisk), which is suitable for patients with poor blood sugar control. Adult patients with type 2 diabetes should combine other oral hypoglycemic drugs on the basis of diet and exercise to improve blood sugar control. According to the press release, Novobio is the world's first basal insulin glucagon-like peptide-1 receptor agonist (GLP-1RA) injection.
In this new diabetes drug, liraglutide is a GLP-1 analog that is injected once a day, and has a 97% similarity to naturally-occurring human GLP-1. Like human GLP-1, liraglutide stimulates insulin secretion and reduces glucagon secretion in a glucose-dependent manner, and reduces body weight and body fat by increasing satiety and reducing energy intake.
Another important component of the new drug-insulin degludec, is a new generation of ultra-long-acting basal insulin analogues, which has the characteristics of stable, safe and effective blood sugar control. It is reported that insulin degludec developed by Novo Nordisk can achieve an ultra-long-acting action time of 42 hours, which enables patients to obtain a convenient experience of flexible injection time when they need it.
According to the press release, deglu insulin and liraglutide injection have a breakthrough fusion of the two-component advantages of the two drugs, complementary mechanisms, and multi-targeted action on multiple pathophysiological mechanisms of type 2 diabetes. The drug is injected once a day, which can effectively control blood sugar throughout the day. The HbA1c compliance rate is as high as 89.9%, which reduces the risk of hypoglycemia and has a clear weight benefit.
Public information shows that as early as 2014, degludec insulin and liraglutide injection (English common name: IDegLira, overseas trade name: Xultophy) was approved for marketing in the EU, becoming the world's first approved basal insulin and GLP- 1RA injection. In 2016, the drug was approved by the US FDA for use in patients with type 2 diabetes who cannot effectively control blood sugar with insulin or GLP-1 analogs alone.
At the annual meeting of the European Society for the Study of Diabetes (EASD) in September 2020, Chinese researchers conducted the DUAL Ⅰ/Ⅱ China study on oral hypoglycemic drugs or basal insulin in the treatment of Chinese type 2 diabetic patients with poor blood sugar control The results are announced.
The DUAL Ⅰ Chinese study confirmed that insulin deglulam and liraglutide injection can effectively reduce glycated hemoglobin (HbA1c), and the risk of hypoglycemia is low; compared with the control group, patients in the combination therapy group gain less weight and have a higher daily insulin dose few. The DUAL Ⅱ Chinese study confirmed that the combination therapy can achieve better blood sugar control compared with the control drug, and more patients achieve HbA1c <7% without hypoglycemia and/or weight gain, and lower daily insulin dosage. Both studies are consistent with the results of the global phase 3 clinical study DUAL project.
Type 2 diabetes is a chronic metabolic disease, which accounts for the vast majority of diabetic patients. The main manifestation of this type of patients is resistance to insulin, that is, there is still close to normal levels of insulin in the body, but the body cannot respond appropriately to insulin, making blood sugar rise and causing diseases. For patients, insulin alone does not have a good effect. As the disease progresses, patients often need to be clinically combined with other hypoglycemic drugs.
The arrival of Novo Nordisk Glutaulin and Liraglutide Injection is expected to bring new treatment options and clinical benefits to patients with type 2 diabetes. Congratulations to Novo Nordisk for another new diabetes drug approved for marketing in China.
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