China's new diabetes drug first published in the "Lancet" sub-public, the second phase of clinical results is good

China's new diabetes drug first published in the "Lancet" sub-public, the second phase of clinical results is good

May 08, 2018 Source: Academic Jingwei

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A few days ago, we heard a good news from China - Huayi Kant Group partner Hua Medicine published its new drug dorzagliatin in the "Lancet Diabetes & Endocrinology" magazine "The Lancet Diabetes & Endocrinology". Phase 2 clinical trial results. The results show that it has good glycemic control benefits in patients with type 2 diabetes in China, and safety and tolerability are also guaranteed.

As we all know, China is a large diabetes country with about 114 million diabetic patients. In addition, it is estimated that there are 150 million pre-diabetes patients in China. If they are not effectively controlled, they will eventually develop diabetes.

Dorzagliatin (formerly known as HMS5552), brought by Hualing Pharmaceuticals, is a glucokinase (GK) activator and the first GK product to enter Phase 3 confirmatory clinical studies worldwide. At the start-up meeting of Phase 3 Clinical, Dr. Chen Li, CEO of Hualing Medicine and author of this study, said: “GK activator HMS5552 repairs the degenerative GK function of type 2 diabetic patients by regulating glucokinase targets. It is the maintenance of the body's blood sugar homeostasis, and is known as the 'constant sugar device'. It has been proven to have reliable safety and clear therapeutic effect in Phase I and Phase II clinical trials. It is considered to be diabetes in the industry. New approaches to patient care have brought new hope to the development of diabetes."

The results of this clinical trial confirm the potential of this new diabetes drug. In the study, the scientists recruited 258 diabetic patients and randomized them into five groups, one of whom received placebo treatment and the other four received different doses of dorzagliatin. The study found a significant improvement in glycated hemoglobin (HbA1c) levels in the 50 mg (twice daily) and 75 mg (twice daily) treatment groups compared to the placebo control group (p < 0.0001). In terms of side effects, there was no significant difference between the control group and the treatment group.

Based on this result, the researchers interpreted that dorzagliatin has good glycemic control and good safety and tolerability.

According to reports, this is the "Lancet" sub-published "first published clinical research results from China on the original innovative drugs for type 2 diabetes." We congratulate the good clinical data obtained by these new drug developers from China, and hope that this new drug will progress smoothly in the subsequent clinical trials, and will benefit the majority of Chinese diabetic patients in the morning!

Reference materials:

[1] Dorzagliatin monotherapy in Chinese patients with type 2 diabetes: a dose-ranging, randomised, double-blind, placebo-controlled, phase 2 study

[2] Hualing Medicine official website

[3] Heavy! Lancet published the first research on the original innovative drug research in China's T2DM – idiabetes WeChat public number

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