NCT05950516尚未招募3 期
Efficacy and Safety of Semaglutide Injection (QLG2065) vs. Ozempic® as add-on to Metformin in Type 2 Diabetics.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 478
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
To evaluate the similarity of the efficacy and safety of semaglutide injection (QLG2065) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.
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 years and ≤75 years old at the time of screening.
- •Subjects diagnosed with type 2 diabetes for at least 6 months (WHO, 1999)
- •Within 60 days before screening, subjects received stable treatment with only metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day), or receive combination metformin (dose ≥ 750 mg/day) and another OAD (alpha-glucosidase inhibitors, sulfonylureas, glinides, SGLT-2i or thiazolidinedione), stable treatment is defined as unchanged medication and daily doses;
- •At the time of screening, for those who have previously been treated with metformin alone, HbA1c ≥ 7.0% and ≤ 11.0%（local lab）; for those who have previously used metformin in combination with another OAD treatment, HbA1c ≥ 7.0% and ≤10.0%（local lab）;
- •BMI≥18.5kg/m2 and ≤35 kg/m2
- •Subjects voluntarily participate in this research, can communicate well with researchers, are willing to maintain the same diet and exercise habits throughout the study, and sign an informed consent form (ICF) .
- •At baseline，HbAlc ≥ 7.0% and ≤ 11.0%（cental lab）
排除标准
- •Known or suspected hypersensitivity to any GLP-1RA or related products, or allergic constitution
- •Treatment with GLP-1RA, DPP-4 inhibitor, or insulin in a period of 60 days before screening. An exception is short-term insulin therapy (≤7 days in total).
- •History of chronic or acute pancreatitis
- •Screening calcitonin value ≥ 50 ng/L (pg/mL)
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
- •Have a history of major cardiovascular and cerebrovascular diseases within 90 days before screening.
- •Known proliferative retinopathy or maculopathy
研究组 & 干预措施
QLG2065
Experimental
Up to 1.0 mg semaglutide (QLG2065)
Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day).
干预措施: Semaglutide (Drug)
Ozempic
Active Comparator
Up to 1.0 mg semaglutide (Ozempic)
Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day).
干预措施: Semaglutide Pen Injector [Ozempic] (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 33
Change from baseline (week 1) to week 33 in glycosylated haemoglobin (HbA1c) was evaluated
次要结局
- Change in HbA1c(Week 21)
- Change in Body Weight(Week 21, 33)
- Percentage of Participants That Achieved Body Weight Loss ≥5%(Week 21, 33)
- Change in Fasting Glucose(Week 21, 33)
- Percentage of Participants Who Achieved HbA1c <7.0% , HbA1c ≤6.5%(Week 21, 33)
研究者
研究点 (1)
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