Zhu D, et al. - In Chinese patients with type 2 diabetes, authors evaluated the efficacy and safety of dorzagliatin monotherapy at different doses. They noted a beneficial effect of dorzagliatin on glycemic control. Over 12 weeks, this monotherapy was found to be safe and well tolerated in Chinese patients with type 2 diabetes.

Methods

• Authors conducted a multicenter, randomized, double-blind, placebo-controlled, phase 2 study.
• Patients were randomly assigned (1:1:1:1:1) to receive oral placebo or one of four doses of oral dorzagliatin (75 mg once a day, 100 mg once a day, 50 mg twice a day, or 75 mg twice a day) using permuted-block randomization, with a block size of ten and without stratification.
• Men or non-fertile women (aged 40–75 years) with type 2 diabetes, with a BMI of 19.0–30.0 kg/m², who were on a diet and exercise regimen, and were previously untreated or treated with metformin or α-glucosidase inhibitor monotherapy were the eligible patients.
• They started the study with a 4-week placebo run-in period followed by a 12-week treatment period.
• The change in HbA_1c from baseline to week 12, which was assessed in all patients who received at least one dose of study drug and had both baseline and at least one post-baseline HbA_1c value, was included in the primary endpoint.
• They evaluated the safety in all patients who received at least one dose of study drug.

Results

• As per data, between September 29, 2015 and August 17, 2016, 258 patients were randomly assigned to one of the five study groups.
• Findings suggested that, at the end of 12 weeks, the least squares mean change in HbA_1c from baseline was -0.35% (95% CI -0.60 to -0.10) in the placebo group, -0.39% (-0.64 to -0.14) in the 75 mg once daily group, -0.65% (-0.92 to -0.38) in the 100 mg once daily group, -0.79% (-1.06 to -0.52) in the 50 mg twice daily group, and -1.12% (-1.39 to -0.86) in the 75 mg twice daily group.
• Results demonstrated that the change in HbA_1c between baseline and 12 weeks was significant in the 50 mg twice daily (p=0.0104) and the 75 mg twice daily (p < 0.0001) groups vs the placebo group.
• Between the treatment groups and the placebo group, the number of adverse events was similar.
• Experts did not note any reports of drug-related serious adverse events or severe hypoglycemia.