[Translation] A multicenter, randomized, open-label, dulaglutide-positive controlled phase III clinical study of exendin-4Fc fusion protein (JY09) injection in adult type 2 diabetic subjects with poor glycemic control after metformin treatment
主要目的:
在二甲双胍治疗后血糖控制不佳的成人2型糖尿病受试者中评价JY09注射液相对于度拉糖肽注射液治疗26周的疗效差异。
次要目的:
评价JY09注射液相对于度拉糖肽注射液治疗成人2型糖尿病受试者54周的疗效差异;
评价JY09注射液相对于度拉糖肽注射液治疗成人2型糖尿病受试者54周的安全性差异;
评价JY09注射液在成人2型糖尿病受试者中的群体药代动力学及暴露-反应关系;
评价JY09注射液在成人2型糖尿病受试者中的免疫原性。
[Translation] Primary objective:
To evaluate the efficacy of JY09 injection compared with dulaglutide injection in adult subjects with type 2 diabetes who have poor glycemic control after metformin treatment for 26 weeks.
Secondary objectives:
To evaluate the efficacy of JY09 injection compared with dulaglutide injection in adult subjects with type 2 diabetes for 54 weeks;
To evaluate the safety of JY09 injection compared with dulaglutide injection in adult subjects with type 2 diabetes for 54 weeks;
To evaluate the population pharmacokinetics and exposure-response relationship of JY09 injection in adult subjects with type 2 diabetes;
To evaluate the immunogenicity of JY09 injection in adult subjects with type 2 diabetes.