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Not yet recruitingNCT07708610Updated Jul 16, 2026

Preadmission GLP-1 Receptor Agonist Plus SGLT2 Inhibitor Use and Early Outcomes After Pneumonia Hospitalization in Adults With Type 2 Diabetes

An observational study in Pneumonia and Type 2 Diabetes Mellitus (T2DM), sponsored by Chung Shan Medical University. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Chung Shan Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
71,775
Ages
18 Years and older
Sex
All
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Study summary

This retrospective observational target-trial emulation uses electronic health record data from the TriNetX US Collaborative Network to compare preadmission glucose-lowering treatment strategies in adults with type 2 diabetes hospitalized with pneumonia. Time zero is the date of the index pneumonia admission. The study compares patients with evidence of prescriptions for both a GLP-1 receptor agonist and an SGLT2 inhibitor in the year before admission with patients prescribed a GLP-1 receptor agonist alone, an SGLT2 inhibitor alone, or usual care. Usual care includes metformin, sulfonylureas, or DPP-4 inhibitors without either study class. The primary outcome is a composite of all-cause death, invasive mechanical ventilation, or renal replacement therapy within 30 days of admission, with the individual components and 12-month mortality, major adverse cardiovascular events, and major adverse kidney events also evaluated. Propensity-score methods are used to reduce bias from nonrandom treatment selection.

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Conditions studied

  • Pneumonia
  • Type 2 Diabetes Mellitus (T2DM)
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 71,775 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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 type 2 diabetes who were hospitalized with pneumonia and received routine clinical care in this network, identified through diagnosis records, laboratory data, encounter records, and medication prescribing data. Comparator-specific cohorts were defined within this source population according to glucose-lowering prescriptions recorded in the year before the index admission, to evaluate preadmission GLP-1 receptor agonist- and SGLT2 inhibitor-based treatment strategies.

Inclusion criteria

  • Adults aged 18 years or older.
  • Type 2 diabetes mellitus
  • Hospitalization with pneumonia during the study period, serving as the index admission
  • Prescription of a GLP-1 receptor agonist, an SGLT2 inhibitor, or usual-care glucose-lowering therapy in the year before the index admission
  • No GLP-1 receptor agonist or SGLT2 inhibitor prescription in the 6 months before the first qualifying prescription

Exclusion criteria

Exclusion Criteria:

  • Type 1 diabetes mellitus, or other specified diabetes types that are not type 2 diabetes
  • Human immunodeficiency virus infection
  • Bariatric surgery
  • Solid-organ transplantation
  • Pneumonia hospitalization, invasive mechanical ventilation, or renal replacement therapy in the year before the index admission
  • End-stage kidney disease, dialysis dependence, ventilator dependence, or tracheostomy status
  • Metastatic malignancy, lung cancer, or palliative care
  • Viral pneumonia, influenza with pneumonia, or COVID-19 around the index admission
  • Acute cardiovascular event in the 6 months before the index admission
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
71,775 participants (estimated)
Patient registry
No

Groups and cohorts

  • GLP-1 RA plus SGLT2i

    Adults with type 2 diabetes hospitalized with pneumonia who had prescriptions for both a GLP-1 receptor agonist and an SGLT2 inhibitor in the year before admission.

  • GLP-1 RA alone

    Adults with type 2 diabetes hospitalized with pneumonia who had a prescription for a GLP-1 receptor agonist, and no prescription for an SGLT2 inhibitor, in the year before admission.

  • SGLT2i alone

    Adults with type 2 diabetes hospitalized with pneumonia who had a prescription for an SGLT2 inhibitor, and no prescription for a GLP-1 receptor agonist, in the year before admission.

  • Usual care

    Adults with type 2 diabetes hospitalized with pneumonia who had a prescription for metformin, a sulfonylurea, or a DPP-4 inhibitor, and no prescription for a GLP-1 receptor agonist or an SGLT2 inhibitor, in the year before admission.

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What researchers measure

Primary outcomes

  1. Composite outcome (all-cause mortality, invasive mechanical ventilation, or renal replacement therapy)

    Time frame: Within 30 days after the index pneumonia admission

Secondary outcomes

  1. All-cause mortality

    Time frame: Within 30 days after the index pneumonia admission

  2. Invasive mechanical ventilation

    Time frame: Within 30 days after the index pneumonia admission

  3. Renal replacement therapy

    Time frame: Within 30 days after the index pneumonia admission

  4. Composite outcome (all-cause mortality, major adverse cardiovascular events, or major adverse kidney events)

    Time frame: Through 12 months after the index pneumonia admission

  5. All-cause mortality

    Time frame: Through 12 months after the index pneumonia admission

  6. Major adverse cardiovascular events

    Time frame: Through 12 months after the index pneumonia admission

  7. Major adverse kidney events

    Time frame: Through 12 months after the index pneumonia admission

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Study locations

1 site
  • Chung Shan Medical University Hospital
    Taichung, Taichung 402, Taiwan
08

References and documents

Publications

  • Simms-Williams N, Treves N, Yin H, Lu S, Yu O, Pradhan R, Renoux C, Suissa S, Azoulay L. Effect of combination treatment with glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors on incidence of cardiovascular and serious renal events: population based cohort study. BMJ. 2024 Apr 25;385:e078242. doi: 10.1136/bmj-2023-078242. PubMed 38663919 ↗
  • Wright AK, Carr MJ, Kontopantelis E, Leelarathna L, Thabit H, Emsley R, Buchan I, Mamas MA, van Staa TP, Sattar N, Ashcroft DM, Rutter MK. Primary Prevention of Cardiovascular and Heart Failure Events With SGLT2 Inhibitors, GLP-1 Receptor Agonists, and Their Combination in Type 2 Diabetes. Diabetes Care. 2022 Apr 1;45(4):909-918. doi: 10.2337/dc21-1113. PubMed 35100355 ↗
  • Palchuk MB, London JW, Perez-Rey D, Drebert ZJ, Winer-Jones JP, Thompson CN, Esposito J, Claerhout B. A global federated real-world data and analytics platform for research. JAMIA Open. 2023 May 13;6(2):ooad035. doi: 10.1093/jamiaopen/ooad035. eCollection 2023 Jul. PubMed 37193038 ↗
  • Topaloglu U, Palchuk MB. Using a Federated Network of Real-World Data to Optimize Clinical Trials Operations. JCO Clin Cancer Inform. 2018 Dec;2:1-10. doi: 10.1200/CCI.17.00067. PubMed 30652541 ↗
  • VanderWeele TJ, Ding P. Sensitivity Analysis in Observational Research: Introducing the E-Value. Ann Intern Med. 2017 Aug 15;167(4):268-274. doi: 10.7326/M16-2607. Epub 2017 Jul 11. PubMed 28693043 ↗
  • Lipsitch M, Tchetgen Tchetgen E, Cohen T. Negative controls: a tool for detecting confounding and bias in observational studies. Epidemiology. 2010 May;21(3):383-8. doi: 10.1097/EDE.0b013e3181d61eeb. PubMed 20335814 ↗
  • Austin PC, Lee DS, Fine JP. Introduction to the Analysis of Survival Data in the Presence of Competing Risks. Circulation. 2016 Feb 9;133(6):601-9. doi: 10.1161/CIRCULATIONAHA.115.017719. PubMed 26858290 ↗
  • Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8. PubMed 21818162 ↗
  • Hernan MA, Wang W, Leaf DE. Target Trial Emulation: A Framework for Causal Inference From Observational Data. JAMA. 2022 Dec 27;328(24):2446-2447. doi: 10.1001/jama.2022.21383. PubMed 36508210 ↗
  • Matthews AA, Danaei G, Islam N, Kurth T. Target trial emulation: applying principles of randomised trials to observational studies. BMJ. 2022 Aug 30;378:e071108. doi: 10.1136/bmj-2022-071108. No abstract available. PubMed 36041749 ↗
  • Hernan MA, Robins JM. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available. Am J Epidemiol. 2016 Apr 15;183(8):758-64. doi: 10.1093/aje/kwv254. Epub 2016 Mar 18. PubMed 26994063 ↗
  • Kosiborod MN, Esterline R, Furtado RHM, Oscarsson J, Gasparyan SB, Koch GG, Martinez F, Mukhtar O, Verma S, Chopra V, Buenconsejo J, Langkilde AM, Ambery P, Tang F, Gosch K, Windsor SL, Akin EE, Soares RVP, Moia DDF, Aboudara M, Hoffmann Filho CR, Feitosa ADM, Fonseca A, Garla V, Gordon RA, Javaheri A, Jaeger CP, Leaes PE, Nassif M, Pursley M, Silveira FS, Barroso WKS, Lazcano Soto JR, Nigro Maia L, Berwanger O. Dapagliflozin in patients with cardiometabolic risk factors hospitalised with COVID-19 (DARE-19): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2021 Sep;9(9):586-594. doi: 10.1016/S2213-8587(21)00180-7. Epub 2021 Jul 21. PubMed 34302745 ↗
  • Coca SG, Singanamala S, Parikh CR. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis. Kidney Int. 2012 Mar;81(5):442-8. doi: 10.1038/ki.2011.379. Epub 2011 Nov 23. PubMed 22113526 ↗
  • Chawla LS, Eggers PW, Star RA, Kimmel PL. Acute kidney injury and chronic kidney disease as interconnected syndromes. N Engl J Med. 2014 Jul 3;371(1):58-66. doi: 10.1056/NEJMra1214243. No abstract available. PubMed 24988558 ↗
  • Eurich DT, Marrie TJ, Minhas-Sandhu JK, Majumdar SR. Risk of heart failure after community acquired pneumonia: prospective controlled study with 10 years of follow-up. BMJ. 2017 Feb 13;356:j413. doi: 10.1136/bmj.j413. PubMed 28193610 ↗
  • Corrales-Medina VF, Alvarez KN, Weissfeld LA, Angus DC, Chirinos JA, Chang CC, Newman A, Loehr L, Folsom AR, Elkind MS, Lyles MF, Kronmal RA, Yende S. Association between hospitalization for pneumonia and subsequent risk of cardiovascular disease. JAMA. 2015 Jan 20;313(3):264-74. doi: 10.1001/jama.2014.18229. PubMed 25602997 ↗
  • Musher DM, Abers MS, Corrales-Medina VF. Acute Infection and Myocardial Infarction. N Engl J Med. 2019 Jan 10;380(2):171-176. doi: 10.1056/NEJMra1808137. No abstract available. PubMed 30625066 ↗
  • Violi F, Cangemi R, Falcone M, Taliani G, Pieralli F, Vannucchi V, Nozzoli C, Venditti M, Chirinos JA, Corrales-Medina VF; SIXTUS (Thrombosis-Related Extrapulmonary Outcomes in Pneumonia) Study Group. Cardiovascular Complications and Short-term Mortality Risk in Community-Acquired Pneumonia. Clin Infect Dis. 2017 Jun 1;64(11):1486-1493. doi: 10.1093/cid/cix164. PubMed 28205683 ↗
  • Corrales-Medina VF, Musher DM, Shachkina S, Chirinos JA. Acute pneumonia and the cardiovascular system. Lancet. 2013 Feb 9;381(9865):496-505. doi: 10.1016/S0140-6736(12)61266-5. Epub 2013 Jan 16. PubMed 23332146 ↗
  • Corrales-Medina VF, Musher DM, Wells GA, Chirinos JA, Chen L, Fine MJ. Cardiac complications in patients with community-acquired pneumonia: incidence, timing, risk factors, and association with short-term mortality. Circulation. 2012 Feb 14;125(6):773-81. doi: 10.1161/CIRCULATIONAHA.111.040766. Epub 2012 Jan 4. PubMed 22219349 ↗
  • Mortensen EM, Coley CM, Singer DE, Marrie TJ, Obrosky DS, Kapoor WN, Fine MJ. Causes of death for patients with community-acquired pneumonia: results from the Pneumonia Patient Outcomes Research Team cohort study. Arch Intern Med. 2002 May 13;162(9):1059-64. doi: 10.1001/archinte.162.9.1059. PubMed 11996618 ↗
  • Kornum JB, Thomsen RW, Riis A, Lervang HH, Schonheyder HC, Sorensen HT. Type 2 diabetes and pneumonia outcomes: a population-based cohort study. Diabetes Care. 2007 Sep;30(9):2251-7. doi: 10.2337/dc06-2417. Epub 2007 Jun 26. PubMed 17595354 ↗

Individual participant data

Plan to share: No — 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.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07708610
Lead sponsor
Chung Shan Medical University
Collaborators
National Science and Technology Council, Taiwan
Responsible party
Yu-Nan Huang (Assistant Professor/Research Fellow, Chung Shan Medical University) — Principal investigator
First posted
Jul 16, 2026
Start date
Jul 31, 2026 (estimated)
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Jul 16, 2026

Study contacts

Pen-Hua Su, PhD
Contact
jen@csh.org.tw
886-4-24739595 ext. 21707
Yu-Nan Huang, PhD
Contact
yunanhuang83@gmail.com
886-4-24739595 ext. 21707

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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