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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChung Shan Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Type 1 diabetes mellitus, or other specified diabetes types that are not type 2 diabetes

Human immunodeficiency virus infection

Bariatric surgery

Solid-organ transplantation

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

71,775 Participants
are grouped into 4 trial groups
Group A: GLP-1 RA plus SGLT2i
Group B: GLP-1 RA alone
Group C: SGLT2i alone
Group D: Usual care

Trial outcomes

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

Other outcomes

Sponsors and contacts

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Chung Shan Medical University

Lead sponsor

National Science and Technology Council, Taiwan

Collaborator

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