[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate CJC-1134-PC injection in patients with type 2 diabetes mellitus with poor glycemic control following metformin monotherapy or metformin combined with insulin secretagogues Efficacy and safety of once-weekly dosing
主要目的:在二甲双胍单药或二甲双胍联合胰岛素促泌剂治疗后血糖控制不佳的2型糖尿病患者中评价CJC-1134-PC注射液每周给药1次、连续给药24周对比安慰剂的有效性。
次要目的:在二甲双胍单药或二甲双胍联合胰岛素促泌剂治疗后血糖控制不佳的2型糖尿病患者中评价CJC-1134-PC注射液每周给药1次:
1.与安慰剂对比,连续给药24周的安全性;
2.连续给药28周和52周的有效性;
3.连续给药28周和52周的安全性。
[Translation] MAIN OBJECTIVE: To evaluate the efficacy of CJC-1134-PC injection administered once a week for 24 weeks versus placebo in patients with type 2 diabetes mellitus with poor glycemic control after metformin monotherapy or metformin combined with insulin secretagogues. effectiveness.
Secondary objective: To evaluate CJC-1134-PC injection once weekly in patients with type 2 diabetes who have poor glycemic control after metformin monotherapy or metformin combined with insulin secretagogues:
1. Compared with placebo, the safety of continuous administration for 24 weeks;
2. The effectiveness of continuous administration for 28 weeks and 52 weeks;
3. The safety of continuous administration for 28 weeks and 52 weeks.