Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
2026年5月5日 更新者：Chipscreen Biosciences, Ltd.
Chiglitazar Add-On to SGLT-2 Inhibitors in Patients With Type 2 Diabetes: A Nationwide, Multicenter Registry Study (C-STAR)
The goal of this observational study is to evaluate the comprehensive clinical efficacy, cardiovascular, renal, and hepatic benefits, as well as the safety of adding Chiglitazar to SGLT-2 inhibitor therapy in adult patients with Type 2 Diabetes Mellitus (T2DM) . The main questions it aims to answer are:
What is the real-world effectiveness of Chiglitazar, when added to an SGLT-2 inhibitor, on glycemic control? What are the effects of this combination therapy on cardiovascular, renal, and hepatic outcomes? What is the overall safety of this treatment regimen?
This is a non-interventional study. Participants will be prescribed Chiglitazar or other oral antidiabetic drugs by their treating physician as part of their routine clinical care. For the purpose of this registry study, data will be collected from their regular medical follow-ups. Participants will:
Attend regular follow-up visits as part of their standard diabetes care. Have data collected from their routine clinical assessments.
研究概览
地位
尚未招聘
条件
研究类型
观察性的
注册 (估计的)
3550
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
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
T2DM patients
描述
Inclusion Criteria:
- Age between 18 and 75 years, inclusive.
- Diagnosis of Type 2 Diabetes Mellitus (T2DM) .
- Receiving stable-dose SGLT-2 inhibitor monotherapy or in combination with one other oral antidiabetic drug for at least one month prior to screening, but with inadequate glycemic control, defined as HbA1c ≥ 7.5%.
- Must be willing to participate and have provided written informed consent.
Exclusion Criteria:
- Current or routine use of insulin therapy.
- Use of three or more antidiabetic drugs within one month prior to screening.
- Current treatment with a thiazolidinedione (TZD) or a GLP-1 receptor agonist (GLP-1 RA).
- Prior treatment with Chiglitazar Sodium.
- Presence of life-threatening comorbidities, severe edema, or severe hepatic impairment (Child-Pugh Class C).
- Laboratory findings meeting any of the following criteria: a) Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN); b) Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Chiglitazar Cohort (Exposure Group)
Participants with T2DM on a background SGLT-2 inhibitor-based therapy who are newly prescribed Chiglitazar by their treating physician.
This cohort includes patients on dual therapy (SGLT-2i + Chiglitazar) or triple therapy (SGLT-2i + Chiglitazar + another oral antidiabetic drug).
|
Prescribed as an add-on therapy to an SGLT-2 inhibitor-based regimen according to the physician's clinical judgment and routine practice
|
|
Comparator Cohort (Control Group)
Participants with T2DM on a background SGLT-2 inhibitor-based therapy who are prescribed oral antidiabetic drugs (other than Chiglitazar)
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Any oral antidiabetic drug (other than Chiglitazar) prescribed by the treating physician as an add-on therapy to an SGLT-2 inhibitor-based regimen.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Glycated Hemoglobin (HbA1c)
大体时间：Baseline, 6 Months
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months
|
Baseline, 6 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
N-terminal pro-B-type natriuretic peptide
大体时间：Baseline, 6 Months, 12 Months
|
To assess the change from baseline in N-terminal pro-B-type natriuretic peptide
|
Baseline, 6 Months, 12 Months
|
|
High-sensitivity C-reactive Protein
大体时间：Baseline, 6 Months, 12 Months
|
To assess the change from baseline in High-sensitivity C-reactive Protein
|
Baseline, 6 Months, 12 Months
|
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Liver Chemistries: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), and Gamma-Glutamyl Transferase (GGT).
大体时间：Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
To assess the change from baseline in Liver Function Test Markers: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), and Gamma-Glutamyl Transferase (GGT).
|
Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
|
Renal Function Markers: estimated Glomerular Filtration Rate, Urine Albumin-to-Creatinine Ratio, Serum Creatinine, Blood Urea Nitrogen, Uric Acid, and Cystatin C
大体时间：Baseline, 6 Months, 12 Months.
|
To assess the change from baseline in markers for chronic kidney disease, including estimated Glomerular Filtration Rate, Urine Albumin-to-Creatinine Ratio, Serum Creatinine, Blood Urea Nitrogen, Uric Acid, and Cystatin C.
|
Baseline, 6 Months, 12 Months.
|
|
Resolution Rate of Metabolic Syndrome
大体时间：6 Months, 12 Months.
|
6 Months, 12 Months.
|
|
|
Proportion of Patients Achieving Glycemic Control Targets
大体时间：3 Months, 6 Months, 9 Months, 12 Months.
|
To assess the percentage of patients reaching predefined Glycated Hemoglobin targets of <6.5%, <7.0%, and <7.5%.
|
3 Months, 6 Months, 9 Months, 12 Months.
|
|
Glycated Hemoglobin
大体时间：Baseline, 3 Months, 9 Months, 12 Months.
|
To assess the change from baseline in Glycated Hemoglobin (HbA1c).
|
Baseline, 3 Months, 9 Months, 12 Months.
|
|
Fasting Blood Glucose
大体时间：Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
To assess the change from baseline in fasting blood glucose.
|
Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
|
Patient-Reported Quality of Life (DSQL) score
大体时间：Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
To measure the change in patient-reported quality of life using the Diabetes-Specific Quality of Life (DSQL) score.
|
Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
|
Incidence of Adverse Events
大体时间：Up to 12 months
|
Up to 12 months
|
|
|
Medication Costs
大体时间：Up to 12 months
|
To assess the medication costs associated with Type 2 Diabetes.
|
Up to 12 months
|
|
Incidence of Major Adverse Cardiovascular Events (MACE)
大体时间：Up to 12 months.
|
To assess the number of participants experiencing one or more components of MACE (a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke).
|
Up to 12 months.
|
|
non-invasive scores for liver steatosis and fibrosis: Fibrosis-4 Index
大体时间：Baseline, 6 Months,12 Months.
|
Baseline, 6 Months,12 Months.
|
|
|
blood pressure (systolic and diastolic)
大体时间：Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
To assess the change from baseline in blood pressure (systolic and diastolic).
|
Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
|
body weight
大体时间：Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
To assess the change from baseline in body weight.
|
Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
|
waist circumference
大体时间：Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
To assess the change from baseline in waist circumference.
|
Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
|
Body Mass Index
大体时间：Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
To assess the change from baseline in Body Mass Index.
|
Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
|
|
Triglycerides（TG）
大体时间：Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Triglycerides（TG）
|
Baseline, 6 Months, 12 Months
|
|
Total Cholesterol (TC)
大体时间：Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Total Cholesterol (TC)
|
Baseline, 6 Months, 12 Months
|
|
Low-Density Lipoprotein Cholesterol (LDL-C)
大体时间：Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
|
Baseline, 6 Months, 12 Months
|
|
High-Density Lipoprotein Cholesterol (HDL-C)
大体时间：Baseline, 6 Months, 12 Months
|
To assess the change from baseline in High-Density Lipoprotein Cholesterol (HDL-C)
|
Baseline, 6 Months, 12 Months
|
|
Non-High-Density Lipoprotein Cholesterol (non-HDL-C）
大体时间：Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C）
|
Baseline, 6 Months, 12 Months
|
|
Free Fatty Acids (FFA）
大体时间：Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Free Fatty Acids (FFA）
|
Baseline, 6 Months, 12 Months
|
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7月18日
初级完成 (估计的)
2028年1月18日
研究完成 (估计的)
2028年7月18日
研究注册日期
首次提交
2026年4月22日
首先提交符合 QC 标准的
2026年5月5日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年5月12日
上次提交的符合 QC 标准的更新
2026年5月5日
最后验证
2026年4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.