NCT07487103尚未招募3 期
A Multicenter, Randomized, Open-label, Parallel-group, Active-controlled Clinical Trial to Evaluate Efficacy and Safety of QLG1091 Versus Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 478
- 主要终点
- Change in HbA1c
研究概览
简要总结
This study is to evaluate the efficacy and safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes. The primary objective is to demonstrate equivalence of QLG1091 and Rybelsus. This study is a randomized, open-label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.
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 (Participant, Investigator)
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
- •Female or male，age 18 to
- •Body mass index (BMI) ≥ 22 kg/m² and ≤ 35 kg/m² at screening.
- •HbA1c of 7.0-10.5 %.
- •Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening.
- •Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose≥1000 mg/day) at least 90 days prior to the day of screening.
排除标准
- •Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
- •History of pancreatitis (acute or chronic).
- •History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- •Subjects presently classified as being in New York Heart Association Class IV.
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- •Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
研究组 & 干预措施
QLG1091
Experimental
干预措施: QLG1091 (Drug)
Rybelsus
Active Comparator
干预措施: Rybelsus (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 26
Change from baseline in HbA1c was evaluated at Week 26
次要结局
未报告次要终点
研究者
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