[Translation] A multicenter, randomized, parallel, placebo (double-blind within the group) and active drug (open) controlled Phase II clinical study to evaluate the efficacy and safety of HEC88473 injection in subjects with type 2 diabetes
主要目的:评价HEC88473在单纯饮食和运动治疗或稳定剂量二甲双胍治疗后血糖控制不佳的2型糖尿病受试者中的有效性。
次要目的:1)评价HEC88473在单纯饮食和运动治疗或稳定剂量二甲双胍治疗后血糖控制不佳的2型糖尿病受试者中的安全性;2)基于群体药代动力学分析方法,评估HEC88473在中国2型糖尿病成人受试者中的药代动力学特征;3)如数据允许,评估HEC88473的暴露量与疗效和不良事件之间的关系。
探索性目的:评价HEC88473的免疫原性特征。
[Translation] Primary objective: To evaluate the efficacy of HEC88473 in subjects with type 2 diabetes who have poor glycemic control after diet and exercise alone or stable doses of metformin.
Secondary objectives: 1) To evaluate the safety of HEC88473 in subjects with type 2 diabetes who have poor glycemic control after diet and exercise alone or stable doses of metformin; 2) To evaluate the pharmacokinetic characteristics of HEC88473 in Chinese adult subjects with type 2 diabetes based on population pharmacokinetic analysis methods; 3) If data permit, to evaluate the relationship between the exposure of HEC88473 and efficacy and adverse events.
Exploratory objective: To evaluate the immunogenicity characteristics of HEC88473.