NCT06589765已完成3 期
A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (OUTSTAND-2)
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 810 人开始时间: 2024年9月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 810
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c at 32 weeks of treatment
研究概览
简要总结
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with dapagliflozin in subjects with type 2 diabetes mellitus with inadequate glycemic control using metformin.
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
- Double (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
- •Male or female, 18-75 age years, both inclusive;
- •Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
- •HbA1c 7.5-11.0% (both inclusive) at screening;
- •Treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening.
排除标准
- •Known or suspected allergy to the investigational drug or its components or excipients.
- •Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- •Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
- •Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
- •Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
研究组 & 干预措施
Treatment group D
Active Comparator
subjects will receive dapagliflozin tablet orally.
干预措施: dapagliflozin tablet (Drug)
Treatment group A
Experimental
subjects will receive HRS-7535 tablet orally at dose 1.
干预措施: HRS-7535 tablet (Drug)
Treatment group B
Experimental
subjects will receive HRS-7535 tablet orally at dose 2.
干预措施: HRS-7535 tablet (Drug)
Treatment group C
Experimental
subjects will receive HRS-7535 tablet orally at dose 3.
干预措施: HRS-7535 tablet (Drug)
结局指标
主要结局
Change from baseline in HbA1c at 32 weeks of treatment
时间窗: at 32 weeks
次要结局
- Percentage of Participants Who Achieved HbA1c <7.0% at Week 32(at 32 weeks)
- Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32(at 32 weeks)
- Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32(at 32 weeks)
- Percentage Change from Baseline in Body Weight, from Baseline to Week 32(at 32 weeks)
- Change from Baseline in Body Weight, from Baseline to Week 32(at 32 weeks)
- Change from Baseline in Waist Circumference, from Baseline to Week 32(at 32 weeks)
研究者
研究点 (1)
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