评价健康受试者皮下注射CJC-1134-PC注射液分别与二甲双胍、阿托伐他汀、华法林药物-药物相互作用的临床研究
[Translation] Clinical study to evaluate the drug-drug interactions of subcutaneous CJC-1134-PC injection with metformin, atorvastatin, and warfarin in healthy subjects
主要目的:评价在健康受试者中皮下注射CJC-1134-PC注射液分别对二甲双胍、阿托伐他汀、华法林的药代动力学的影响,为CJC-1134-PC注射液临床合并用药提供科学依据。 次要目的:1、评价在健康受试者中皮下注射CJC-1134-PC注射液对华法林的药效学的影响;2、评价在健康受试者中皮下注射CJC-1134-PC注射液分别与二甲双胍、阿托伐他汀、华法林联合给药的安全性。
[Translation] Primary objective: To evaluate the effect of subcutaneous injection of CJC-1134-PC injection on the pharmacokinetics of metformin, atorvastatin, and warfarin in healthy subjects, and to provide a scientific basis for the clinical combination of CJC-1134-PC injection. Secondary objectives: 1. To evaluate the effect of subcutaneous injection of CJC-1134-PC injection on the pharmacodynamics of warfarin in healthy subjects; 2. To evaluate the safety of subcutaneous injection of CJC-1134-PC injection in combination with metformin, atorvastatin, and warfarin in healthy subjects.
一项多中心、随机、双盲、安慰剂对照III期临床研究以评价在接受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CJC-1134-PC注射液每周给药1次的有效性和安全性
[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of CJC-1134-PC injection once weekly in patients with type 2 diabetes who have poor glycemic control after treatment with metformin alone or metformin combined with insulin secretagogues
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] Primary objective: To evaluate the efficacy of CJC-1134-PC injection once a week for 24 weeks compared with placebo in patients with type 2 diabetes who have poor glycemic control after treatment with metformin alone or metformin combined with insulin secretagogues.
Secondary objective: To evaluate the efficacy of CJC-1134-PC injection once a week for 24 weeks compared with placebo in patients with type 2 diabetes who have poor glycemic control after treatment with metformin alone or metformin combined with insulin secretagogues:
1. Safety of continuous administration for 24 weeks compared with placebo;
2. Efficacy of continuous administration for 28 and 52 weeks;
3. Safety of continuous administration for 28 and 52 weeks.
一项多中心、随机、双盲、安慰剂对照III期临床研究以评价未接受过抗糖尿病药物治疗的血糖控制不佳的2型糖尿病患者中CJC-1134-PC注射液每周给药1次的有效性和安全性
[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of CJC-1134-PC injection once weekly in patients with type 2 diabetes and poor glycemic control who have not received antidiabetic drug treatment
主要目的:在未接受抗糖尿病药物治疗的血糖控制不佳的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:在未接受抗糖尿病药物治疗的血糖控制不佳的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] Primary objective: To evaluate the efficacy of CJC-1134-PC injection once a week for 24 weeks compared with placebo in patients with type 2 diabetes and poor glycemic control who are not receiving antidiabetic drugs.
Secondary objective: To evaluate the efficacy of CJC-1134-PC injection once a week for 24 weeks compared with placebo in patients with type 2 diabetes and poor glycemic control who are not receiving antidiabetic drugs:
1. Safety of continuous administration for 24 weeks compared with placebo;
2. Efficacy of continuous administration for 28 and 52 weeks;
3. Safety of continuous administration for 28 and 52 weeks.
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