medwireNews: Findings from the SEED trial provide further evidence to suggest that the dual-acting glucokinase activator dorzagliatin improves glycemic control compared with placebo and has a favorable safety profile in people with type 2 diabetes.
These phase 3 results follow a phase 2 dose-ranging study of dorzagliatin, reported previously by medwireNews, which demonstrated that the drug reduced glycated hemoglobin (HbA1c) levels relative to placebo without increasing the risk for adverse events previously associated with this medication class. The 75 mg twice daily dose was selected as the minimum therapeutically effective dose for further investigation.
SEED included 463 treatment-naïve adult patients from China with type 2 diabetes who were randomly assigned to receive 24 weeks of treatment with oral dorzagliatin 75 mg twice daily or placebo. Participants had an average age of approximately 53 years and BMI of 25 kg/m2, and around 35% were women.
Presenting the trial at the virtual ADA 80th Scientific Sessions, Li Chen (Hua Medicine, Shanghai, China) reported that the least squares (LS) mean reduction in HbA1c from baseline to week 24 was 1.07% for the 310 participants given dorzagliatin and 0.50% for the 153 given placebo, a significant difference. Baseline HbA1c measures were 8.34% (67 mmol/mol) and 8.38% (68 mmol/mol), respectively.
Chen said that dorzagliatin had a fast onset of action, with significant between-group differences in the reduction of HbA1c levels seen at week 4.
Dorzagliatin treatment also resulted in a significantly greater reduction in 2-hour postprandial plasma glucose over 24 weeks compared with placebo (2.83 vs 0.50 mmol/L), as well as a significantly higher rate of homeostatic control (HbA1c <7.0% without hypoglycemia; 45.0 vs 21.5%).
Moreover, dorzagliatin improved beta-cell function, said Chen, with a LS mean increase in HOMA2-β score of 2.56 in the active treatment group compared with a decrease of 0.72 in the placebo arm.
He reported that the agent was “well tolerated with a good safety profile” over the 24-week treatment period, with similar rates of adverse events in the dorzagliatin and placebo arms, no deaths, and no treatment-related serious adverse events. Hypoglycemia occurred in one patient in the dorzagliatin group, and no cases of severe hypoglycemia were reported.
“We are very encouraged that the results support [dorzagliatin 75 mg twice daily] as a monotherapy for the treatment of drug-naïve type 2 diabetes patients in China,” concluded Chen.
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