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PneumoniaNCT07708610

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

An observational study of Pneumonia and Type 2 Diabetes Mellitus (T2DM), run by Chung Shan Medical University at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia, Type 2 Diabetes Mellitus (T2DM)
How many people
71,775 participants
Where
1 siteTaiwan
Study dates
31 Jul 2026to 31 Aug 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site
  • Chung Shan Medical University Hospital

    Taichung, Taichung, 402

    Pen-Hua Su, PhD, 886-4-24739595 ext. 21707, jen@csh.org.tw

    Yu-Nan Huang, PhD, 886-4-24739595 ext. 21707, yunanhuang83@gmail.com

Other trials in Taiwan

About this study

Official title: Preadmission GLP-1 Receptor Agonist Plus SGLT2 Inhibitor Use and Early Outcomes After Pneumonia Hospitalization in Adults With Type 2 Diabetes: A Target Trial Emulation

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.

Medical subject headings
Pneumonia, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07708610
Study groupRoleWhat they receive
GLP-1 RA plus SGLT2iAdults 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 aloneAdults 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 aloneAdults 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 careAdults 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Within 30 days after the index pneumonia admission

Secondary outcomes (7)
  1. All-cause mortality

    Measured: Within 30 days after the index pneumonia admission

  2. Invasive mechanical ventilation

    Measured: Within 30 days after the index pneumonia admission

  3. Renal replacement therapy

    Measured: Within 30 days after the index pneumonia admission

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

    Measured: Through 12 months after the index pneumonia admission

  5. All-cause mortality

    Measured: Through 12 months after the index pneumonia admission

  6. Major adverse cardiovascular events

    Measured: Through 12 months after the index pneumonia admission

  7. Major adverse kidney events

    Measured: Through 12 months after the index pneumonia admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start31 Jul 2026 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
71,775 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07708610
Sponsor's protocol ID
CS2-26152
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia and Type 2 Diabetes Mellitus (T2DM), run by Chung Shan Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pen-Hua Su, PhD (886-4-24739595 ext. 21707, jen@csh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite outcome (all-cause mortality, invasive mechanical ventilation, or renal replacement therapy) (time frame: Within 30 days after the index pneumonia admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07708610, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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