[Translation] A multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical study to evaluate the efficacy and safety of HL08 in patients with type 2 diabetes whose blood sugar is poorly controlled by diet and exercise alone
主要目的: 通过糖化血红蛋白(HbA1c)自基线到第12周的变化,评价不同剂量HL08(0.75mg、1.5mg和3mg)每周一次(QW)皮下注射对单纯依靠饮食和运动血糖控制不佳的T2DM患者的疗效。
次要目的:
评价不同剂量HL08在T2DM患者中的安全性。
评价不同剂量HL08在T2DM患者中的血糖调控作用。
评价HL08在T2DM患者中的群体药代动力学(PopPK)特征。
评价HL08在T2DM患者中的免疫原性。
[Translation] Primary objective: To evaluate the efficacy of different doses of HL08 (0.75mg, 1.5mg and 3mg) subcutaneously injected once a week (QW) in patients with T2DM whose blood glucose is poorly controlled by diet and exercise alone, based on the change in glycated hemoglobin (HbA1c) from baseline to week 12.
Secondary objectives:
To evaluate the safety of different doses of HL08 in patients with T2DM.
To evaluate the blood glucose regulation effect of different doses of HL08 in patients with T2DM.
To evaluate the population pharmacokinetic (PopPK) characteristics of HL08 in patients with T2DM.
To evaluate the immunogenicity of HL08 in patients with T2DM.