Dorzagliatin promising novel hypoglycemic drug for type 2 diabetes: Study
China: A randomized controlled trials (RCTs) meta-analysis published in the Medicine Journal has shed light on the safety and efficacy of dorzagliatin, a novel glucokinase activator, in treating type 2 diabetes mellitus (T2DM).
The researchers revealed favourable effects of dorzagliatin in hypoglycemic control and effectively reduced the glycated haemoglobin (HbA1c), fasting blood glucose (FBG), and 2h postprandial blood glucose levels in T2D patients. Dorzagliatin stimulated insulin secretion during the initial phase and exerted a hypoglycemic effect.
The study stated that the incidence of adverse events, such as elevated cardiovascular risk and blood lipids, warrants further investigations through long-term clinical trials.
New drugs have emerged in recent years for treating type 2 diabetes, encompassing SGLT2 inhibitors (sodium-dependent glucose transporters 2 inhibitors), GLP-1 agonists (glucagon-like peptide 1 receptor agonist), DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), etc. They are frequently administered as adjunct treatments when metformin monotherapy is ineffective. However, at present, the glycemic control rate among T2DM patients remains suboptimal, indicating unfavourable long-term prognostic outcomes and a higher risk of complications. Therefore, it is necessary to enhance the health education of type 2 diabetes. Moreover, there is an urgent need to pioneer more safe, effective, and convenient hypoglycemic drugs.
Dorzagliatin is a newly developed glucokinase activator that reportedly exerted superior hypoglycemic effects and fewer occurrences of adverse reactions in previous studies and is presently recognized as a promising therapeutic drug. Considering this, Wu Yuqian, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China, and colleagues aimed to evaluate the safety and efficacy of dorzagliatin for treating type 2 diabetes.
For this purpose, the researchers systematically searched seven databases from 2016 to 2023. RCTs comparing dorzagliatin with a placebo for T2D were applicable for containing this study. The relevant data was extracted, and a meta-analysis was implemented using RevMan 5.4 software.
The meta-analysis included three studies comprising 1332 patients. HbA1c levels were used as the major indicator of efficacy, 2h postprandial blood glucose, FBG, Homa-β, and Homa-IR were the Secondary outcome measures.
The researchers reported the following findings:
- Dorzagliatin significantly reduced blood glucose levels and enhanced insulin resistance compared with the placebo group.
- In terms of safety, no serious adverse events occurred.
- Lipid-related indicators, especially triglyceride levels, and the incidence of hypoglycemia were higher in patients in the dorzagliatin group compared with those in the control group, but the increase from baseline was mild.
In conclusion, compelling evidence underscores dorzagliatin benefits in lowering the levels of 2h-PFG, FBG, and HbA1c, as well as promoting insulin secretion and attenuating insulin resistance.
Moreover, dorzagliatin administration did not elevate the incidence of hypoglycemia, proteinuria, upper respiratory tract infection, fluctuations in liver enzyme levels, and other serious adverse events.
"These favourable outcomes conjointly position dorzagliatin as a promising novel hypoglycemic drug," the researchers concluded.
Reference:
Wu, Yuqian MDa,*; Wang, Kai MDb; Su, Jingyang MDc; Liu, Xin MDd. Efficacy and safety of dorzagliatin, a novel glucokinase activators, in the treatment of T2DM: A meta-analysis of randomized controlled trials. Medicine 103(8):p e36916, February 23, 2024. | DOI: 10.1097/MD.0000000000036916
