Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
2026年10月29日 更新者:Jiangsu HengRui Medicine Co., Ltd.
A Phase III, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
The purpose of this study is to evaluate efficacy and safety of SHR-3167 versus Insulin glargine in insulin-naive type 2 diabetes inadequately controlled on non-insulin anti-diabetic drugs. The hypothesis is that SHR-3167 is non-inferior to insulin glargine in the change of HbA1c from baseline after 26 weeks of treatment.
研究概览
研究类型
介入性
注册 (估计的)
450
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Liping Xiang
- 电话号码:+0518-82342973
- 邮箱:liping.xiang.lx7@hengrui.com
研究联系人备份
- 姓名:Shujin Cheng
- 电话号码:+86 18205130725
- 邮箱:shujin.cheng@hengrui.com
学习地点
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210029
- First Affiliated Hospital of Nanjing Medical University
-
首席研究员:
- Yun Liu
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200233
- Shanghai Sixth People's Hospital
-
首席研究员:
- Weiping Jia
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Before participating in any activities related to this trial, I have agreed and signed the informed consent form, and I am willing and able to follow the trial protocol to complete the study.
- I am 18 years or older when signing the informed consent, with no gender restriction.
- According to the 'Chinese Guidelines for Diabetes Prevention and Treatment (2024 edition)', I have been diagnosed with T2DM for at least 180 days before screening.
- Before screening, I have been on stable treatment with 1 to 3 of non-insulin antihyperglycemic drugs for at least 90 days.
- At screening, my HbA1c measured by the central lab is between 7.0% and 11.0%, inclusive.
- At screening, my body mass index (BMI) is ≤40.0 kg/m².
- Female participants of childbearing potential and male participants with partners of childbearing potential agree to use effective contraception after signing the informed consent, and have no plans to donate eggs/sperm; women of childbearing potential have a negative pregnancy test during the screening period and are not breastfeeding.
Exclusion Criteria:
- Abnormal ECG findings that are clinically significant and may affect participant safety.
- Poorly controlled blood pressure.
- Diagnosis or suspected type 1 diabetes (T1DM), latent autoimmune diabetes in adults (LADA), specific types of diabetes, or secondary diabetes.
- level 2 or 3 hypoglycemia or hypoglycemia with unconsciousness in the past 6 months; or ≥2 episodes of level 3 hypoglycemia in the past year before screening.
- Diabetic ketoacidosis, lactic acidosis, or hyperglycemic hyperosmolar state/coma within the past 6 months.
- Severe chronic diabetic complications; or non-proliferative diabetic retinopathy requiring local treatment.
- Malignant tumors within the past 5 years, or high risk of cancer onset/recurrence, or presence of potential malignant tumors.
- Use of insulin within the 2 years
- Participation in any drug or medical device clinical trial within 90 days.
- Any condition that the investigator deems may endanger participant safety, interfere with trial outcome evaluation, affect protocol compliance, or otherwise make participation inappropriate.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Treatment group A
SHR-3167 Injection |
SHR-3167 Injection |
|
有源比较器:Treatment group B
Insulin glargine (IGlar) |
Insulin glargine (IGlar) |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in HbA1c from baseline to week 26 (non-inferiority test)
大体时间:baseline to week 26
|
baseline to week 26
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Percentage of time in range (TIR) between 3.9-10.0 mmol/L (inclusive) during weeks 23 to 26, assessed by continuous glucose monitoring system (CGMS)
大体时间:weeks 23 to 26
|
weeks 23 to 26
|
|
Change in HbA1c from baseline to week 26 (superiority test)
大体时间:baseline to week 26
|
baseline to week 26
|
|
Change in HbA1c from baseline to week 52
大体时间:baseline to week 52
|
baseline to week 52
|
|
Percentage of participants at week 26 and 52 achieving HbA1c <7%
大体时间:week 26 and 52
|
week 26 and 52
|
|
Percentage of participants at week 26 and 52 achieving HbA1c <7% without level 2-3 hypoglycemia;
大体时间:week 26 and 52
|
week 26 and 52
|
|
Change in fasting plasma glucose (FPG) from baseline to week 26 and 52
大体时间:baseline to week 26 and 52
|
baseline to week 26 and 52
|
|
Change in pre-breakfast self-monitored blood glucose (SMBG) from baseline to week 26 and 52
大体时间:baseline to week 26 and 52
|
baseline to week 26 and 52
|
|
Percentage of time in range (TIR) of 3.9-10.0 mmol/L (inclusive) measured by CGMS during weeks 49-52
大体时间:weeks 49-52
|
weeks 49-52
|
|
Incidence and event rate of hypoglycemia from baseline to week 26 and 52
大体时间:baseline to week 26 and 52
|
baseline to week 26 and 52
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年11月1日
初级完成 (估计的)
2027年10月1日
研究完成 (估计的)
2028年7月1日
研究注册日期
首次提交
2026年10月29日
首先提交符合 QC 标准的
2026年10月29日
首次发布 (实际的)
2026年11月6日
研究记录更新
最后更新发布 (实际的)
2026年11月6日
上次提交的符合 QC 标准的更新
2026年10月29日
最后验证
2026年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.