NCT07060456招募中3 期
A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, able and willing to provide a written informed consent
- •Diagnosed with type 2 diabetes ≥ 90 days；
- •On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days;
- •HbA1c was 7.5%~11.0% (both inclusive);
- •Body Mass Index (BMI) ≥22 kg/m2 at screening.
排除标准
- •A history of type 1 diabetes, specific diabetes, or secondary diabetes;
- •Have a history of severe hypoglycemia within t180 days prior to screening;
- •History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening；
- •Have a history of malignancy within 5 years;
- •Known or suspected allergy or intolerance to the investigational medicinal products or related products;
- •Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days;
- •Any conditions that the Investigator judges might not be suitable to participate in the trial.
研究组 & 干预措施
Treatment group B: HRS9531-high dose
Experimental
干预措施: HRS9531 (Drug)
Treatment group C
Placebo Comparator
干预措施: Placebo (Drug)
Treatment group A: HRS9531-low dose
Experimental
干预措施: HRS9531 (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: from baseline to Week 40
Change in HbA1c after 40 weeks of treatment.
次要结局
- Proportion of subjects reaching HbA1<7.0%(from baseline to Week 40)
- Proportion of subjects reaching HbA1≤6.5%(from baseline to Week 40)
- Change in FPG(from baseline to Week 40)
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score(From baseline to Week 40)
研究者
研究点 (1)
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