NCT06393348已完成2 期
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2024年5月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Change in HbA1c from baseline at Week 16
研究概览
简要总结
2 weeks screening period, 3 weeks run-in period, 16 weeks double-blind treatment period, to evaluate the Safety and Efficacy of HRS-7535 in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and SGLT2i.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 subjects, 18-75 years of age at the time of signing informed consent;
- •Have T2DM (based on the 2020 Chinese Diabetes Society [CDS] diagnostic criteria)
- •HbA1c 为 7.5%≤HbA1c≤11.0% at the screening visit；
- •FPG≤15 mmol/L at the screening visit;
- •Have been treated with an SGLT2i with metformin, for at least 8 weeks;
- •At screening and random visit, 20.0 ≤BMI≤ 35.0 kg/m2;
- •Able and willing to provide a written informed consent
排除标准
- •Have type 1 diabetesmellitus;
- •History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
- •Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
- •history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
- •Surgery is planned during the trial;
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
研究组 & 干预措施
Group A
Experimental
Subjects will receive escalated dose of HRS-7535 administered orally
干预措施: HRS-7535 (Drug)
Group B
Experimental
Subjects will receive dose of HRS-7535 administered orally
干预措施: HRS-7535 (Drug)
Group C
Placebo Comparator
Subjects will receive Placebo administered orally
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c from baseline at Week 16
时间窗: Week 16
次要结局
- The change in in body weight from baseline to 16 weeks(16 weeks)
- Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks(16 weeks)
- The change in fasting blood glucose from baseline to 16 weeks(16 weeks)
- The change in 7-point SMBG profile from baseline to 16 weeks(16 weeks)
- Proportion of subjects achieving HbA1c target of ≤6.5% at 16 weeks(16 weeks)
研究者
研究点 (1)
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