How safe and effective is dorzagliatin treatment in patients with type 2 diabetes?

This study evaluated the effectiveness and long-term safety of dorzagliatin in patients with type 2 diabetes (T2D) without previous antidiabetic treatment. The authors concluded that dorzagliatin blood glucose (sugar) levels with no serious side effects in these patients. 

Glucokinase is a protein involved in regulating blood glucose levels. Abnormalities that decrease glucokinase activity result in insulin resistance and T2D.

Glucokinase activators (GKAs) are glucose-lowering medications that can decrease HbA1c levels and improve the function of beta cells (pancreatic cells that make insulin) in the pancreas by increasing glucokinase activity. Dorzagliatin is an orally administered GKA that has shown a good safety and effectiveness profile in small studies with patients with T2D. However, further evaluations in larger studies are needed to assess the effectiveness and safety of dorzagliatin in patients with T2D.

This study included 463 patients with T2D. 310 patients were randomly assigned to a dorzagliatin treatment group and received 75 mg of dorzagliatin twice daily. 153 patients were given a placebo. Treatment was given for 24 weeks. After 24 weeks, all patients received dorzagliatin for another 28 weeks. 

After 24 weeks, the HbA1c level (blood glucose control over the past 2-3 months) decreased from baseline by 1.07% in the dorzagliatin group compared to 0.50% in the placebo group. An HbA1c level of less than 7.0% was achieved by 42.5% of patients treated with dorzagliatin compared to 17.3% of patients given a placebo at week 24.

There was no occurrence of severely reduced blood glucose (hypoglycemia) due to dorzagliatin treatment.

The study showed that dorzagliatin treatment had a good safety profile and improved glucose control in previously untreated patients with T2D.

The study was conducted in a Chinese population so results may not be generalizable to populations with other genetic backgrounds. The study was funded by Hua Medicine, the manufacturer of dorzagliatin.