[Translation] Comparison of the efficacy and safety of ZT001 injection and Novotel® subcutaneous injection in patients with type 2 diabetes with poor glycemic control after metformin treatment: a multicenter, randomized, open, parallel-controlled phase III clinical trial
主要目的:评价ZT001注射液与诺和泰®在二甲双胍治疗后血糖控制不佳的T2DM患者中皮下注射治疗的疗效。次要目的:以诺和泰®为对照,评价ZT001注射液在二甲双胍治疗后血糖控制不佳的T2DM患者中皮下注射治疗的安全性;评价ZT001注射液在成年T2DM患者中的群体药代动力学(PopPK);评价ZT001注射液在成年T2DM患者中的免疫原性。
[Translation] Primary objective: To evaluate the efficacy of subcutaneous injection of ZT001 injection and Novota® in patients with T2DM whose blood sugar is poorly controlled after metformin treatment. Secondary objectives: Using Novota® as a control, to evaluate the safety of subcutaneous injection of ZT001 injection in patients with T2DM whose blood sugar is poorly controlled after metformin treatment; to evaluate the population pharmacokinetics (PopPK) of ZT001 injection in adult patients with T2DM; to evaluate the immunogenicity of ZT001 injection in adult patients with T2DM.