Hua Medicine announced topline results from SEED (also known as HMM0301), the first Phase III trial with dorzagliatin. Dorzagliatin is a first-in-class glucokinase activator. The 52-week trial investigated the efficacy and safety of 75mg BID dorzagliatin in 463 patients with Type 2 diabetes, with an initial 24-week double blinded, placebo-controlled treatment, followed by an open label 28-week treatment. The primary efficacy and safety endpoints were evaluated at 24 weeks. In the 28-week open label treatment period, dorzagliatin continued to exhibit a safe and well-tolerated clinical profile. A safety analysis based on study safety population demonstrated that dorzagliatin was well tolerated and had a good safety profile. The incidence of adverse events was similar between the dorzagliatin-treated and placebo groups. There was less than 1% hypoglycemia with blood glucose < 3 mmol/L during the 52-week treatment period. During the 28-week open-label treatment, patients also saw a continued reduction of insulin resistance (insulin resistance is the hallmark of Type 2 diabetes). SEED (Efficacy and Safety Evaluation of Dorzagliatin) study design: SEED is a randomized, double-blind, placebo-controlled Phase III study in 463 drug naïve type 2 diabetes patients. Patients are treated with twice-daily doses of dorzagliatin (75 mg) or placebo, randomized 2:1. The clinical study evaluated the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period, for a total of 52 weeks. During the 28-week open-label period, both patient groups were treated with twice-daily doses of dorzagliatin (75 mg). The trial was conducted in compliance with the guidelines of the Chinese Society of Endocrinology, which require physicians to educate patients and strictly enforce improved exercise and dietary control, as well as continuous self-monitoring, in treating Type 2 diabetes. The trial was conducted at 40 clinical sites across China led by Professor Dalong Zhu, President of the Chinese Diabetes Society.