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 aprile 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Osservativo
Iscrizione (Stimato)
118805
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Pen-Hua Su, PhD
- Numero di telefono: 21707 886-4-24739595
- Email: jen@csh.org.tw
Backup dei contatti dello studio
- Nome: Yu-Nan Huang, PhD
- Numero di telefono: 21707 886-4-24739595
- Email: yunanhuang83@gmail.com
Luoghi di studio
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Taichung
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Taichung, Taichung, Taiwan, 402
- Chung Shan Medical University Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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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.
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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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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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All-cause mortality
Lasso di tempo: From 90 days after treatment initiation through up to 60 months of follow-up
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From 90 days after treatment initiation through up to 60 months of follow-up
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Major Adverse Cardiovascular Events
Lasso di tempo: From 90 days after treatment initiation through up to 60 months of follow-up
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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
Lasso di tempo: From 90 days after treatment initiation through up to 60 months of follow-up
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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
Lasso di tempo: From 90 days after treatment initiation through up to 60 months of follow-up
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From 90 days after treatment initiation through up to 60 months of follow-up
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
31 maggio 2026
Completamento primario (Stimato)
30 giugno 2026
Completamento dello studio (Stimato)
30 giugno 2026
Date di iscrizione allo studio
Primo inviato
26 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 aprile 2026
Primo Inserito (Effettivo)
5 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- CS1-26035
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .