A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection With Ozempic ® in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
This is a 32-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and the active comparator in patients with type 2 diabetes mellitus who have inadequate glycemic control with metformin. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic® injection abdominal subcutaneous injection will be given according to their groups weekly for 32 weeks. Follow-up for 4 weeks after administration.
Trial product will be add-on to subject's stable pre-trial metformin.
The study included a screening period (up to 2 weeks), run-in period（6 weeks），baseline, administration period(32 weeks), and a follow-up period (4 weeks). The duration of the study will be approximately 44 weeks for a participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18-75 years (both inclusive) at the time of signing informed consent
- •Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 6 weeks prior to screening with metformin ≥ 1500 mg (or maximum tolerated dose ≥ 1000 mg)
- •HbA1c 7.5 - 11.0 % (both inclusive) (screening)
- •HbA1c 7.0 - 10.5 % (both inclusive) (randomisation)
- •BMI 18.5-35 kg/m2 (both inclusive)
排除标准
- •Other types of diabetes besides Type 2 diabetes
- •A history of acute diabetes complications within 6 months before screening
- •A history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other high-risk factors that may lead to pancreatitis
- •Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
- •Acute coronary or cerebrovascular event within 3 months before screening or randomisation
- •Heart failure, New York Heart Association (NYHA) class IV
- •Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 6 weeks before screening. An exception is short-term treatment (≤7 days in total) with insulin in connection with inter-current illness
- •Fasting Plasma Glucose (FPG) ≥ 13.9mmol/L
- •Screening calcitonin value ≥ 35 ng/L (pg/mL)
- •Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2
- •Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
研究组 & 干预措施
Experimental group
干预措施: HDG1901 (Drug)
Active Comparator
干预措施: Ozempic® (Drug)
结局指标
主要结局
Change in HbA1c from baseline
时间窗: Week 32
次要结局
- C-peptide(Week 20, Week 32)
- Change in HbA1c from baseline(Week 20)
- Change in Fasting Plasma Glucose(FPG) from baseline(Week 20， Week 32)
- HbA1c ≤ 6.5%(Week 20, Week 32)
- HbA1c ≤ 7.0%(Week 20，Week 32)
- Insulin(Week 20, Week 32)