NCT07472725进行中（未招募）2 期
A Randomized, Open-Label, Treat-to-Target, Parallel-Controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of Fixed-Dose Titration and Individualized-Dose Titration of SHR-3167 in Adults With Type 2 Diabetes Inadequately Controlled With Oral Antihyperglycemic Agents
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- The percentage of participants who experienced at least one hypoglycemic event.
研究概览
简要总结
The purpose of this study is to evaluate the safety and glycemic control of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18-65 years old at the time of signing informed consent.
- •Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to day of screening.
- •During the screening process, at least one of the oral antihyperglycemic agents must be used (no more than 3 types), and the treatment must be stable for at least 2 months.
- •Female participants of childbearing potential and their partners are male participants of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 4 months after signing the informed consent form and have no plans to donate eggs/sperm; Female participants of childbearing potential have a negative pregnancy test during the screening period and are not lactating.
排除标准
- •Uncontrollable hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
- •Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
- •Known or suspected allergy or intolerance to the test drug or excipient.
- •There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- •There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases.
- •Malignancy within 5 years prior to screening or high risk of recurrence.
- •Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
- •Participated in clinical trials of any drug or medical device within 3 months prior to screening.
研究组 & 干预措施
SHR-3167 fixed-dose titration group
Experimental
干预措施: SHR-3167 Injection (Drug)
SHR-3167 individualized-dose titration group
Experimental
干预措施: SHR-3167 Injection (Drug)
SHR-3167 individualized-dose titration group
Experimental
干预措施: SHR-3167 Injection Placebo (Drug)
SHR-3167 fixed-dose titration group
Experimental
干预措施: SHR-3167 Injection Placebo (Drug)
结局指标
主要结局
The percentage of participants who experienced at least one hypoglycemic event.
时间窗: From the baseline to 20-weeks treatment.
次要结局
- The event rate of hypoglycemic events.(From the baseline to 20-weeks treatment.)
- Change in glycosylated hemoglobin (HbA1c) from baseline.(From the baseline to 20-weeks treatment.)
- Change in fasting plasma glucose (FPG) from baseline.(From the baseline to 20-weeks treatment.)
- The relative change in HbA1c after 20-weeks treatment compared to the baseline level.(From the baseline to 20-weeks treatment.)
研究者
研究点 (2)
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