[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-dose burgagliflozin maleate tablets in Chinese adult patients with type 2 diabetes
主要目的:
评价马来酸博格列汀片在中国成年2 型糖尿病患者中不同剂量每周一次连续12 周给药的安全性和耐受性。
次要目的:
(1)评价马来酸博格列汀片在中国成年2 型糖尿病患者中不同剂量每周一次连续12 周给药的药代动力学(PK)及药效学(PD)特征。
(2)初步评价马来酸博格列汀片在中国成年2 型糖尿病患者中不同剂量每周一次连续12 周给药的有效性。
[Translation] Primary objective:
To evaluate the safety and tolerability of different doses of burgagliptin maleate tablets administered once a week for 12 consecutive weeks in Chinese adult patients with type 2 diabetes.
Secondary objectives:
(1) To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of different doses of burgagliptin maleate tablets administered once a week for 12 consecutive weeks in Chinese adult patients with type 2 diabetes.
(2) To preliminarily evaluate the efficacy of different doses of burgagliptin maleate tablets administered once a week for 12 consecutive weeks in Chinese adult patients with type 2 diabetes.