▎ WuXi AppTec content team editor
Recently, an inhibitor of SGLT2 (sodium-glucose synergistic transporter 2), proline hengrflozin tablets (trade name: Ruiqin), was approved by the State Drug Administration of China (NMPA) for improving glycemic control in adults with type 2 diabetes.
According to the official website of NMPA, the listing of the drug will provide new treatment options for adult type 2 diabetic patients.
Screenshot source: NMPA official website
Common chronic metabolic diseases
Type 2 diabetes is a common chronic metabolic disease. In the past 30 years, the prevalence of type 2 diabetes in China has increased significantly.
According to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)", the prevalence of diabetes in China has reached 11.2%, with about 120 million patients, accounting for 30% of the total number of diabetics in the world. Among all people with diabetes, type 2 diabetes accounts for more than 90%.
Type 2 diabetes can lead to the typical symptoms of diabetes mellitus - "three more and one less", that is, polydipsia, polyuria, polyphagia, and unexplained weight loss. At the same time, type 2 diabetes is also a progressive disease, and as the course of the disease progresses, blood sugar has a tendency to gradually rise.
If blood glucose is not well controlled, long-term hyperglycemia will be harmful to the health and life of patients, and can cause acute complications of various organs (such as diabetic ketoacidosis, hyperglycemic hyperosmolarity) and chronic complications (such as diabetic nephropathy, diabetic retinopathy, diabetic foot), especially the eyes, heart, blood vessels, kidneys, nerves, etc., causing organ insufficiency or failure, resulting in disability or premature death.
For type 2 diabetes, there is no radical cure at present, only through drug therapy, surgical treatment and lifestyle intervention, etc., to achieve blood glucose control, avoid or delay the occurrence and development of diabetic complications, reduce disability rate and mortality, thereby improving the quality of life of patients and prolonging life.
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SGLT2 inhibitors
At present, humans have developed a variety of hypoglycemic drugs for patients with type 2 diabetes to control blood sugar and improve their lives, such as metformin, various types of insulin, GLP-l (glucagon-like peptide-1) receptor agonists, DPP-4 (dipeptyl peptidase 4) inhibitors, SGLT2 (sodium-glucose synergistic transporter 2) inhibitors, etc.
SGLT2 inhibitors are a class of new oral hypoglycemic drugs that have been highly valued in recent years, which can increase urine glucose excretion by inhibiting SGLT2, reducing the reabsorption of glucose filtered by renal tubules, and lowering the renal threshold of glucose. In addition, the excretion and osmotic diuretic effect of urine glucose also have the effect of weight loss and blood pressure.
The Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition) point out that in addition to hypoglycemic effects, SGLT2 inhibitors also have a renal protective effect, which helps to reduce the risk of diabetic nephropathy progression or cardiovascular events; can significantly improve the risk of heart failure hospitalization in patients with type 2 diabetes, especially those with atherosclerotic cardiovascular disease (ASCVD); and has a certain weight loss and antihypertensive effect.
According to the China Drug Clinical Trial Registration and Information Publicity Platform, proline hepagliflozin has completed 22 clinical trials for type 2 diabetes mellitus, including a phase 3 clinical trial of proline hepagliflozin combined with metformin in patients with type 2 diabetes mellitus with poor control of metformin, and a phase 3 clinical trial of the efficacy and safety of proline hepatitisin monotherapy for patients with type 2 diabetes mellitus with poor control of diet and exercise alone.
In addition, in addition to diabetes, proline hepagliflozin has also been explored in other indications. According to the official website of the Drug Evaluation Center (CDE) of the State Food and Drug Administration of China, proline hengreachflozin has also obtained a number of clinical trials with implied licenses for the following indications: for adult patients with chronic heart failure (NYHAII.-IV. grade) with reduced ejection fraction, reducing the risk of cardiovascular death, heart failure hospitalization or emergency heart failure; combined with irbesartan for the treatment of type 2 diabetic nephropathy with hypertension.
We expect that with the launch of hepagliflozin proline, it will help patients with type 2 diabetes better control their blood sugar and bring health benefits, and that more studies will benefit more people as more studies develop.