Theracos Holdings Ltd.

Primary purpose To evaluate the safety and tolerability of THR-1442 in healthy subjects; Secondary purpose To establish the pharmacokinetic characteristics of THR-1442 in healthy subjects; Based on the pharmacokinetic data of THR-1442 in healthy subjects in the US and Japanese populations, to indirectly compare the pharmacokinetic characteristics of THR-1442 in the Chinese population.

Primary objective: To evaluate the reduction of HbA1c from baseline after 24 weeks of treatment with Bexagliflozin or dapagliflozin in patients with type 2 diabetes (T2DM) who are receiving monotherapy with metformin ≥1500 mg/day and whose glycosylated hemoglobin (HbA1c) is poorly controlled, and to demonstrate that the efficacy of Bexagliflozin is non-inferior to that of dapagliflozin. Secondary objectives: Compare the change in body weight from baseline at week 24 between bexagliflozin and dapagliflozin treatment groups Compare the change in fasting plasma glucose (FPG) from baseline at week 24 between bexagliflozin and dapagliflozin treatment groups Compare the proportion of subjects who achieved glycemic response (defined as HbA1c <7.0% and <6.5%) at week 24 between bexagliflozin and dapagliflozin treatment groups Compare the change in blood pressure from baseline at week 24 between bexagliflozin and dapagliflozin treatment groups Compare the change in 2h postprandial blood glucose (MTT test 2h point) from baseline at week 24 between bexagliflozin and dapagliflozin treatment groups Safety objectives: Compare the effects of bexagliflozin and dapagliflozin treatment groups on the incidence of related adverse events (AEs) Compare the effects of bexagliflozin and dapagliflozin treatment groups on general safety assessments