苯甲酸复格列汀片在不同程度肾功能不全患者及匹配的肾功能正常健康志愿者中的药代动力学研究
[Translation] Pharmacokinetic study of fogliptin benzoate in patients with different degrees of renal insufficiency and matched healthy volunteers with normal renal function
比较不同程度肾功能不全患者和性别、年龄、体重指数(BMI)匹配的肾功能正常健康受试者单剂量口服苯甲酸复格列汀片的药代动力学特征。
评价单剂量口服苯甲酸复格列汀片在不同程度肾功能不全患者及肾功能正常健康受试者中的药效学特征及安全性。
[Translation] To compare the pharmacokinetics of single-dose oral fogliptin benzoate tablets in patients with different degrees of renal insufficiency and sex, age, and body mass index (BMI)-matched healthy subjects with normal renal function.
To evaluate the pharmacodynamics and safety of single-dose oral fogliptin benzoate tablets in patients with different degrees of renal insufficiency and healthy subjects with normal renal function.
评价苯甲酸复格列汀片在经二甲双胍治疗不能有效控制血糖的2型糖尿病患者中有效性和安全性的Ⅲ期临床研究
[Translation] Phase III clinical study to evaluate the efficacy and safety of fogliptin benzoate in patients with type 2 diabetes who cannot effectively control blood sugar after metformin treatment
通过与安慰剂平行对照,评价苯甲酸复格列汀片(12mg/天)与二甲双胍联用时连续服药24周治疗2型糖尿病患者的有效性和安全。 评价苯甲酸复格列汀片(12mg/天)与二甲双胍联用时连续服药52周治疗2型糖尿病患者的有效性和安全。
[Translation] To evaluate the efficacy and safety of fogliptin benzoate (12 mg/day) in combination with metformin for 24 weeks in patients with type 2 diabetes in parallel with placebo. To evaluate the efficacy and safety of fogliptin benzoate (12 mg/day) in combination with metformin for 52 weeks in patients with type 2 diabetes.
评价苯甲酸复格列汀片在经饮食和运动不能有效控制血糖的2型糖尿病患者中有效性和安全性的Ⅲ期临床研究
[Translation] Phase III clinical study to evaluate the efficacy and safety of fogliptin benzoate in patients with type 2 diabetes who cannot effectively control blood sugar through diet and exercise
通过与安慰剂、苯甲酸阿格列汀片平行对照,评价苯甲酸复格列汀片在12mg/天剂量下连续服药24周治疗2型糖尿病患者的有效性和安全性。 评价苯甲酸复格列汀片在12mg/天剂量下连续服药52周治疗2型糖尿病患者的有效性和安全性。
[Translation] By comparing with placebo and alogliptin benzoate tablets, the efficacy and safety of fogliptin benzoate tablets at a dose of 12 mg/day for 24 weeks in the treatment of patients with type 2 diabetes were evaluated. To evaluate the efficacy and safety of fogliptin benzoate tablets at a dose of 12 mg/day for 52 weeks in the treatment of patients with type 2 diabetes.
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