Chinese-led medicine Dorzagliatin and metformin combined drug phase III achieved positive results.

In the group of 766 patients with type 2 diabetes who took the maximum tolerable dose of metformin (?1500mg/day) were still not effectively controlled, in which dorzagliatin was able to perform quickly, effectively and continuously reduce HbA1c levels at 24 weeks A1c decreased by 1.02% (least-squares average) from the baseline, better than 0.36% (minimum-difference mean mean) in the placebo control group (p value, 0.0001, 95% confidence interval of -0.79 to -0.53).
the Standard for HbA1c below 7.0% of the treatment standards set by the American Diabetes Association (ADA), the 24-week compliance rate was 44.4% among subjects who combined dorzagliatin with metformin, and 10.7% of subjects who took metformin alone.
the HOMA2-beta, HOMA2-IR indicators, and the two-hour post-meal blood glucose and fasting blood glucose values in the dorzagliatin treatment group, were also statistically significantly improved compared to the placebo control group.
dorzagliatin continued to show good safety and tolerance during the 24-week treatment period. During the
24 weeks of treatment, the incidence of hypoglycemia (blood sugar was less than .lt;3 mmol/L) was less than 1%, no serious drug-related adverse reactions occurred, and no serious hypoglycemia events occurred.
China-Led Pharmaceuticals plans to submit NDA in China after completing the 52-week study of HMM0302, and work with partners to promote the commercialization of dorzagliatin in China and the rest of the world.
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