Early GLP-1 Receptor Agonist and SGLT2 Inhibitor Add-On Strategies in Adults With Obesity, Type 2 Diabetes, Cardiovascular-Kidney-Metabolic Syndrome Stage 2-3, and Metabolic Dysfunction-Associated Steatotic Liver Disease
2026年5月28日 更新者：Yu-Nan Huang、Chung Shan Medical University
Early GLP-1 Receptor Agonist and SGLT2 Inhibitor Add-On Strategies in Adults With Obesity, Type 2 Diabetes, Cardiovascular-Kidney-Metabolic Syndrome Stage 2-3, and Metabolic Dysfunction-Associated Steatotic Liver Disease: A Target Trial Emulation
This retrospective observational target-trial emulation uses electronic health record data from the TriNetX US Collaborative Network to compare early treatment intensification strategies in adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who initiate a GLP-1 receptor agonist or an SGLT2 inhibitor as background therapy.
Within each background-therapy cohort, patients who added the complementary class within 90 days of initiation were compared against patients who did not, with prespecified comparisons against both the overall non-complementary cohort and the analytical subset who initiated usual-care add-on therapy (DPP-4 inhibitors, sulfonylureas, or insulin) within the same window.
The primary outcome is all-cause mortality over 60 months, with major adverse cardiovascular, kidney, and liver outcomes also evaluated.
Propensity-score matching is used to reduce bias from nonrandom treatment selection.
研究概览
地位
完全的
研究类型
观察性的
注册 (实际的)
118805
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。
学习地点
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Taichung
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Taichung、Taichung、台湾、402
- Chung Shan Medical University Hospital
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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
Adults will be selected from the TriNetX US Collaborative Network, a distributed database of de-identified electronic health records contributed by participating healthcare organizations across multiple clinical systems and practice settings.
The study population consists of adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who received routine clinical care in this network and were identified through diagnosis records, body mass index data, laboratory data, and medication prescribing data.
Four mutually exclusive cohorts were defined by background therapy (GLP-1 receptor agonist or SGLT2 inhibitor) and 90-day add-on status, supporting four prespecified pairwise comparisons of early complementary add-on against monotherapy or against usual-care add-on (DPP-4 inhibitor, sulfonylurea, or insulin).
描述
Inclusion Criteria:
- Adults aged 18 years or older.
- BMI ≥27 kg/m², or diagnosis codes consistent with obesity
- Type 2 diabetes mellitus
- Cardiovascular-kidney-metabolic syndrome stage 2-3
- Metabolic dysfunction-associated steatotic liver disease
- New initiation of GLP-1 receptor agonist therapy or SGLT2 inhibitor therapy during the study period as background therapy
- No prescription of either GLP-1 receptor agonist or SGLT2 inhibitor within the 6-month washout window before background therapy initiation
Exclusion Criteria:
- Type 1 diabetes mellitus, or other specified diabetes types that are not type 2 diabetes
- Human immunodeficiency virus infection
- Other chronic, alcohol-related, or secondary liver diseases
- Prior bariatric surgery
- Prior solid-organ transplantation
- Hepatocellular carcinoma or liver transplant within 1 year before background therapy initiation
- Major cardiovascular, kidney, or liver event within the 6-month window before background therapy initiation
- Transplant-related complications
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 |
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GLP-1 RA with SGLT2i Add-On
Adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who initiated GLP-1 receptor agonist therapy and added an SGLT2 inhibitor within 90 days after treatment initiation.
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GLP-1 RA monotherapy
Adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who initiated GLP-1 receptor agonist therapy and did not receive early add-on therapy with an SGLT2 inhibitor within 90 days after treatment initiation.
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SGLT2i with GLP-1 RA Add-On
Adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who initiated SGLT2 inhibitor therapy and added a GLP-1 receptor agonist within 90 days after treatment initiation.
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SGLT2i monotherapy
Adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who initiated SGLT2 inhibitor therapy and did not receive early add-on therapy with a GLP-1 receptor agonist within 90 days after treatment initiation.
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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 |
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All-cause Mortality (Comparison 1)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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All-cause mortality from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 1, comparing adults with obesity, type 2 diabetes, CKM syndrome stage 2-3, and MASLD who initiated GLP-1 RA therapy with early SGLT2i add-on versus those who initiated GLP-1 RA therapy without early SGLT2i add-on (monotherapy).
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From 90 days after treatment initiation through up to 60 months of follow-up
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All-cause Mortality (Comparison 2)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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All-cause mortality from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 2, comparing adults with obesity, type 2 diabetes, CKM syndrome stage 2-3, and MASLD who initiated GLP-1 RA therapy with early SGLT2i add-on versus those who initiated GLP-1 RA therapy with usual care (DPP-4 inhibitor, sulfonylurea, or insulin add-on).
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From 90 days after treatment initiation through up to 60 months of follow-up
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All-cause Mortality (Comparison 3)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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All-cause mortality from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 3, comparing adults with obesity, type 2 diabetes, CKM syndrome stage 2-3, and MASLD who initiated SGLT2i therapy with early GLP-1 RA add-on versus those who initiated SGLT2i therapy without early GLP-1 RA add-on (monotherapy).
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From 90 days after treatment initiation through up to 60 months of follow-up
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All-cause Mortality (Comparison 4)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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All-cause mortality from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 4, comparing adults with obesity, type 2 diabetes, CKM syndrome stage 2-3, and MASLD who initiated SGLT2i therapy with early GLP-1 RA add-on versus those who initiated SGLT2i therapy with usual care (DPP-4 inhibitor, sulfonylurea, or insulin add-on).
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From 90 days after treatment initiation through up to 60 months of follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Major Adverse Cardiovascular Events (Comparison 1)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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Composite of acute myocardial infarction, cardiac arrest, intracerebral or intracranial hemorrhage, and cerebral infarction from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 1, comparing GLP-1 RA with early SGLT2i add-on versus GLP-1 RA monotherapy.
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From 90 days after treatment initiation through up to 60 months of follow-up
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Major Adverse Cardiovascular Events (Comparison 2)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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Composite of acute myocardial infarction, cardiac arrest, intracerebral or intracranial hemorrhage, and cerebral infarction from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 2, comparing GLP-1 RA with early SGLT2i add-on versus GLP-1 RA with usual care.
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From 90 days after treatment initiation through up to 60 months of follow-up
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Major Adverse Cardiovascular Events (Comparison 3)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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Composite of acute myocardial infarction, cardiac arrest, intracerebral or intracranial hemorrhage, and cerebral infarction from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 3, comparing SGLT2i with early GLP-1 RA add-on versus SGLT2i monotherapy.
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From 90 days after treatment initiation through up to 60 months of follow-up
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Major Adverse Cardiovascular Events (Comparison 4)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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Composite of acute myocardial infarction, cardiac arrest, intracerebral or intracranial hemorrhage, and cerebral infarction from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 4, comparing SGLT2i with early GLP-1 RA add-on versus SGLT2i with usual care.
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From 90 days after treatment initiation through up to 60 months of follow-up
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Major Adverse Kidney Events (Comparison 1)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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Composite of end-stage kidney disease, dialysis dependence or initiation, kidney failure, and dialysis-related procedures from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 1, comparing GLP-1 RA with early SGLT2i add-on versus GLP-1 RA monotherapy.
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From 90 days after treatment initiation through up to 60 months of follow-up
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Major Adverse Kidney Events (Comparison 2)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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Composite of end-stage kidney disease, dialysis dependence or initiation, kidney failure, and dialysis-related procedures from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 2, comparing GLP-1 RA with early SGLT2i add-on versus GLP-1 RA with usual care.
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From 90 days after treatment initiation through up to 60 months of follow-up
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Major Adverse Kidney Events (Comparison 3)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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Composite of end-stage kidney disease, dialysis dependence or initiation, kidney failure, and dialysis-related procedures from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 3, comparing SGLT2i with early GLP-1 RA add-on versus SGLT2i monotherapy.
|
From 90 days after treatment initiation through up to 60 months of follow-up
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Major Adverse Kidney Events (Comparison 4)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
|
Composite of end-stage kidney disease, dialysis dependence or initiation, kidney failure, and dialysis-related procedures from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 4, comparing SGLT2i with early GLP-1 RA add-on versus SGLT2i with usual care.
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From 90 days after treatment initiation through up to 60 months of follow-up
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Major Adverse Liver Outcomes (Comparison 1)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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Composite of hepatic decompensation (ascites, hepatic encephalopathy, variceal bleeding, spontaneous bacterial peritonitis, hepatic failure, hepatorenal syndrome), hepatocellular carcinoma, and liver transplantation from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 1, comparing GLP-1 RA with early SGLT2i add-on versus GLP-1 RA monotherapy.
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From 90 days after treatment initiation through up to 60 months of follow-up
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Major Adverse Liver Outcomes (Comparison 2)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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Composite of hepatic decompensation, hepatocellular carcinoma, and liver transplantation from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 2, comparing GLP-1 RA with early SGLT2i add-on versus GLP-1 RA with usual care.
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From 90 days after treatment initiation through up to 60 months of follow-up
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Major Adverse Liver Outcomes (Comparison 3)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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Composite of hepatic decompensation, hepatocellular carcinoma, and liver transplantation from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 3, comparing SGLT2i with early GLP-1 RA add-on versus SGLT2i monotherapy.
|
From 90 days after treatment initiation through up to 60 months of follow-up
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Major Adverse Liver Outcomes (Comparison 4)
大体时间：From 90 days after treatment initiation through up to 60 months of follow-up
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Composite of hepatic decompensation, hepatocellular carcinoma, and liver transplantation from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 4, comparing SGLT2i with early GLP-1 RA add-on versus SGLT2i with usual care.
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From 90 days after treatment initiation through up to 60 months of follow-up
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Ndumele CE, Neeland IJ, Tuttle KR, Chow SL, Mathew RO, Khan SS, Coresh J, Baker-Smith CM, Carnethon MR, Despres JP, Ho JE, Joseph JJ, Kernan WN, Khera A, Kosiborod MN, Lekavich CL, Lewis EF, Lo KB, Ozkan B, Palaniappan LP, Patel SS, Pencina MJ, Powell-Wiley TM, Sperling LS, Virani SS, Wright JT, Rajgopal Singh R, Elkind MSV, Rangaswami J; American Heart Association. A Synopsis of the Evidence for the Science and Clinical Management of Cardiovascular-Kidney-Metabolic (CKM) Syndrome: A Scientific Statement From the American Heart Association. Circulation. 2023 Nov 14;148(20):1636-1664. doi: 10.1161/CIR.0000000000001186. Epub 2023 Oct 9.
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 (实际的)
2017年1月1日
初级完成 (实际的)
2026年3月31日
研究完成 (实际的)
2026年3月31日
研究注册日期
首次提交
2026年4月26日
首先提交符合 QC 标准的
2026年4月29日
首次发布 (实际的)
2026年5月5日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年5月28日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- CS1-26035
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared.
This retrospective observational study uses de-identified electronic health record data from the TriNetX US Collaborative Network.
Access to individual-level data is restricted by data use agreements, institutional policies, and privacy protections.
Researchers who meet eligibility requirements may obtain access to similar de-identified data through a TriNetX license or through participating institutions.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.