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
28. maj 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
118805
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Taichung
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Taichung, Taichung, Taiwan, 402
- Chung Shan Medical University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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).
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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All-cause Mortality (Comparison 1)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Major Adverse Cardiovascular Events (Comparison 1)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
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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 4)
Tidsramme: 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 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)
Tidsramme: 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)
Tidsramme: 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.
|
From 90 days after treatment initiation through up to 60 months of follow-up
|
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Major Adverse Liver Outcomes (Comparison 3)
Tidsramme: 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.
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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 4)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2017
Primær færdiggørelse (Faktiske)
31. marts 2026
Studieafslutning (Faktiske)
31. marts 2026
Datoer for studieregistrering
Først indsendt
26. april 2026
Først indsendt, der opfyldte QC-kriterier
29. april 2026
Først opslået (Faktiske)
5. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CS1-26035
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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