In early November 2021, the new drug "Siglitata sodium" for treating diabetes was approved for marketing by the my country Drug Administration, and it has been one year since then. This drug is an original drug and is a major new drug innovation technology support project in my country. It is a new generation of insulin-based anti-glycemic drugs independently designed, synthesized, screened, developed and tested by my country. The product name is "Shuangluoping".
Diabetes was a "difficulty" before the 1920s. Its essence was that a series of complications caused by irreversible damage to the human body's metabolic function. The cause was that after glucose was converted into blood sugar, the insulin that could not be secreted by the pancreatic islets effectively transported to the cells. The abnormal increase in blood sugar in the human body, slowly inducing various complications in the body, such as nervous system lesions, cardiovascular and cerebrovascular diseases, kidney diseases, etc.
The typical symptoms of diabetes are eating more, drinking more, urinating more, and losing weight . In 1979, the International Diabetes Organization divided the symptoms into two categories: type 1 diabetes and html type 12 diabetes .
1 diabetes is caused by defects in the body's immune system or hereditary, accounting for about 10% of the total number of diabetes, mainly relying on insulin injection to survive; type 2 diabetes is caused by eating and drinking casually, causing hyperlipidemia, and there is a problem of insulin deficiency or resistance. If not treated in time, it will gradually worsen, accounting for about 90% of the diabetes type.
Diabetes cannot be cured so far, but they can be controlled by drugs. Currently, there are mainly biguanides, glycosidase inhibitors , DPPIV enzyme inhibitors, GLP1 agonists, SGLT2 inhibitors, insulin, etc. Since type 2 diabetes is acquired and accounts for the majority of diabetes, most drugs, such as biguanides, insulin, and insulin promotion, sensitization or inhibition, are developed and used around type 2 diabetes.
In the past, the treatment of diabetes mainly focused on "lowering sugar" and "sugar control" to develop drugs, with a single business. The new stage of "one-specific and multi-energy" anti-glycemic drugs are more popular, such as the SGLT2 inhibitor engagliflozin, which not only lowers glycemic, but also treats heart failure ; the GLP1 agonist somaglutide, in addition to controlling sugar, it also controls weight and deals with Alzheimer's disease. For future antidiabetic drugs, "one specialty and multi-energy" is the standard.
Speaking of sugar control and lowering sugar, insulin is the only hormone in the body that lowers sugar.
The 1920s was a booming period for research on diabetes. Scientists extracted insulin from pigs, but it was easy to mismatch the patient and have allergic reactions.
1921 metformin was born, and it was confirmed to have a hypoglycemic effect in 1929. The mechanism of action is that even if the insulin is not working, it doesn’t matter, metformin can be pushed up. But the drug was born at the wrong time. It was the time when the antidiabetic drugs were competing for beauty. It was silent for many years and was not approved for sale by the US FDA until 1995.
There are many types of patients with diabetes. Metformin is not universal. Later, insulin secretagogue, inhibitor , etc. were developed, namely sulfonylurea , non-sulfonylurea, "Xliptin", "Xlipin", etc., but it may cause hypoglycemia and have many side effects of varying sizes.
Later, insulin sensitizer was discovered. The first generation was called troglitazone, which was too toxic to hepatotoxic; the second generation of rosiglitazone and pioglitazone have made great changes, but they are both "foreign household registrations". my country can either copy or use imported drugs until the original siglitata sodium was released.
siglitata sodium is a brand new drug for the treatment of type 2 diabetes, called PPRA full agonist, an insulin sensitizer, the world's first, and the world's earliest drug to complete the Phase III clinical trial and the first to go on the market. It can not only control blood sugar levels, but also deal with problems such as lipid metabolism disorders and abnormal blood pressure.
siglitata sodium's special ability is to focus on some key receptor , that is, PPAR, which plays the role of "one stone and three birds with one bird" and activates three subtypes of the receptor: PPARα, PPARγ, and PPARδ, which play an important role in human metabolic syndrome.
PPARα is closely related to lipid metabolism and is mainly found in the liver, which means that siglitazole can deal with fatty liver problems.
PPARγ is related to insulin sensitivity, inflammation, fat levels, blood pressure, etc. Sometimes abnormal indicators may also indicate liver cancer .
PPARδ is related to immunity, cholesterol , fat control, atherosclerosis, etc., reflecting the degree of organ activity.
siglitazole took nineteen years of research and development. It was accepted for listing application in September 2019. It was launched in August 2020. It was used for the Phase 2 clinical trial of the treatment of non-alcoholic fatty liver in March 2021. It was approved by the my country Medical Administration Bureau in November 2021.
This drug is suitable for controlling blood sugar in type 2 diabetes, and considers factors such as diet and exercise. The single drug specification is 16mg/tablet, 2 or 3 tablets each time according to the condition, once a day.
clinical studies show that 24 weeks of treatment of siglitazole can reduce the absolute value of glycated hemoglobin by 1.32%-1.52%. Compared with the control drugs, there are obvious advantages in indicators such as fasting blood sugar , blood sugar , insulin resistance number, and free fatty acid . In terms of security, no serious incidents were reported.
However, this drug still has some side effects, such as occasional anemia , edema , and may have a regulatory effect on female patients' ovulation, so be careful when taking the medication.
data shows that siglitazole has benefited from the market for one year, with more than 20,000 patients with type 2 diabetes.
believes that in the future, more excellent domestic drugs will appear around the "one specialty and multi-energy" to reduce sugar control and reduce various difficult problems of diabetes.
