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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

29. april 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. The study compares patients who, within 90 days of starting background therapy, add the alternate agent, add usual-care glucose-lowering therapy, or do not receive early add-on therapy. Usual-care add-on therapy includes DPP-4 inhibitors, sulfonylureas, or insulin. The primary outcome is all-cause mortality over 60 months, with major cardiovascular events, major kidney events, and major liver outcomes also evaluated. Propensity-score methods are used to reduce bias from nonrandom treatment selection.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

118805

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Pen-Hua Su, PhD
  • Telefonnummer: 21707 886-4-24739595
  • E-mail: jen@csh.org.tw

Undersøgelse Kontakt Backup

Studiesteder

  • Taiwan
    • Taichung
      • Taichung, Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital

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. Comparator-specific cohorts were defined within this source population to evaluate early GLP-1 receptor agonist- and SGLT2 inhibitor-based treatment strategies.

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
  • Initiation of GLP-1 receptor agonist therapy or SGLT2 inhibitor therapy during the study period

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

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
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.
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.
GLP-1 RA with usual care
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 received early usual-care glucose-lowering add-on therapy with a DPP-4 inhibitor, sulfonylurea, or insulin within 90 days after treatment initiation, without early SGLT2 inhibitor add-on therapy.
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.
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.
SGLT2i with usual care
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 received early usual-care glucose-lowering add-on therapy with a DPP-4 inhibitor, sulfonylurea, or insulin within 90 days after treatment initiation, without early GLP-1 receptor agonist add-on therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
All-cause mortality
Tidsramme: From 90 days after treatment initiation through up to 60 months of follow-up
From 90 days after treatment initiation through up to 60 months of follow-up

Sekundære resultatmål

Resultatmål
Tidsramme
Major Adverse Cardiovascular Events
Tidsramme: From 90 days after treatment initiation through up to 60 months of follow-up
From 90 days after treatment initiation through up to 60 months of follow-up
Major Adverse Kidney Events
Tidsramme: From 90 days after treatment initiation through up to 60 months of follow-up
From 90 days after treatment initiation through up to 60 months of follow-up
Major Adverse Liver Outcomes
Tidsramme: From 90 days after treatment initiation through up to 60 months of follow-up
From 90 days after treatment initiation through up to 60 months of follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chung Shan Medical University

Samarbejdspartnere

National Science and Technology Council, Taiwan

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.

Generelle publikationer

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 (Anslået)

31. maj 2026

Primær færdiggørelse (Anslået)

30. juni 2026

Studieafslutning (Anslået)

30. juni 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)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 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

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Sponsorer og samarbejdspartnere

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CROs by country

CROs in Taiwan

Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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