[Translation] A randomized, double-blind, placebo- and active drug-controlled phase II study to evaluate the efficacy and safety of UBT251 injection in patients with type 2 diabetes
主要目的:在2型糖尿病患者中评价UBT251注射液连续给药24周后的有效性,为Ⅲ期临床试验推荐给药剂量。次要目的:1) 评价UBT251注射液连续给药24周在2型糖尿病患者中的安全性;2) 评价UBT251注射液在2型糖尿病患者中的药代/药效动力学特征;3) 评价UBT251注射液在2型糖尿病患者中的免疫原性特征;4) 评价UBT251注射液对2型糖尿病患者胰岛功能的影响。
[Translation] Primary objective: To evaluate the efficacy of UBT251 injection after 24 weeks of continuous administration in patients with type 2 diabetes and to recommend the dosage for Phase III clinical trials. Secondary objectives: 1) To evaluate the safety of UBT251 injection after 24 weeks of continuous administration in patients with type 2 diabetes; 2) To evaluate the pharmacokinetic/pharmacodynamic characteristics of UBT251 injection in patients with type 2 diabetes; 3) To evaluate the immunogenicity characteristics of UBT251 injection in patients with type 2 diabetes; 4) To evaluate the effect of UBT251 injection on pancreatic islet function in patients with type 2 diabetes.