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On December 18, Huali Pharmaceuticals today announced the core results of the 28-week safety assessment phase of the second phase 3 registered clinical study DAWN (Dawn Study, also known as HMM0302) of Dozagliatin.
public information shows that Dozagliatin is the world's first dual-acting glucose kinase activator designed to control the development of progressive degenerative diabetes by restoring blood sugar stability in people with type 2 diabetes.
, Huali Pharmaceuticals has completed two phase 3 registered clinical studies of the single-drug treatment of the product and the combined use of metformin.
the company plans to submit a new dozagliatin application to China's State Drug Administration. the
DAWN study, the second phase 3 registered clinical study of Huali medicine, lasted 53 weeks, including 52 weeks of treatment and the next week of safe follow-up, in 767 patients with type 2 diabetes, with the aim of studying the effectiveness and safety of Dozagliatin (75 mg/time, twice daily).
the first 24 weeks of the trial were double-blind, placebo-controlled therapy to assess the main efficacy and safety endpoints of the trial, and the last 28 weeks were open to continuous observation and evaluation of the safety of dozagliatin.
During the 24-week double-blind treatment period and the 28-week open treatment period, Dozagliatin showed good safety and tolerance, with similar rates of adverse events in the treatment group and control groups, and the risk of hypoglycemia (blood sugar below .lt;3 mmol/L) during the 52-week treatment period was less than 1%.
, HOMA2-IR measurements, the main marker of type 2 diabetes, showed a decrease in insulin resistance in patients.
2020, Hualiu Pharmaceuticals announced that the DAWN study had achieved the main efficacy and safety endpoint during the double-blind trial period, with good safety and tolerance, with remarkable efficacy.
results of the entire 52-week treatment were analyzed based on core data.
28 weeks of open treatment, patients who had previously been treated with placebo and metformin were given dozagliatin and metformin instead.
chart below shows a decrease in glycation hemoglobin levels in both treatment groups over a 52-week period.
Photo Source: The main subjects of the DAWN study were patients with an average diabetes history of nearly 6 years and who had failed metformin-based treatment (1500 mg/day), while the first phase 3 registered clinical study was conducted on patients with an average diabetes history of 1 year and who had never been treated with diabetes medication.
In two different groups of people, Dozagliatin showed the same positive efficacy and safety results, and in both trials, Dozagliatin was able to continuously improve β cellular function and insulin resistance, significantly reducing blood sugar levels two hours after meals.
type 2 diabetes is a global disease that is increasingly exacerbated by poor lifestyle habits such as obesity, sedentaryness and nutritional imbalances.
, existing treatments for diabetes have failed to achieve precise treatment of type 2 diabetes at the source, and have failed to address the underlying causes of insulin resistance and β cellular degeneration.
: The successful completion of Phase III registered clinical research by Hua-Li Pharmaceuticals. Retrieved Dec 18, 2020, from Source: Medical Mission Hills