DelfaGLP-1 Atlas

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GLP1-SGLT2-CKM

Completed

Early Add-On Combination of GLP-1 Receptor Agonist and SGLT2 Inhibitor in People With Cardiovascular-Kidney-Metabolic Stage 2-3

Associations of Early Add-On GLP-1 Receptor Agonist and SGLT2 Inhibitor Therapy With Mortality and Kidney Outcomes in Adults With Obesity and Type 2 Diabetes Across Cardiovascular-Kidney-Metabolic Stages 2-3: A Target-Trial Emulation

Asset

GLP-1 / incretin class catch-all

Listed sites

0

Recruiting sites

—

Enrollment

451,036

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•All-cause death

Identifiers

Registered as

NCT IDNCT07465926
Org study IDCS1-25149
Secondary IDCSH-2025-C-012Chung Shan Medical University Hospital
Secondary IDCSH-2025-C-023Chung Shan Medical University Hospital
Secondary IDNSTC 113-2314-B-040-026-MY2National Science and Technology Council, Taiwan
Secondary IDNSTC 114-2622-B-040-001National Science and Technology Council, Taiwan

Timeline

Milestones

Study start2017-01-01actual
Primary completion2026-01-31actual
Study completion2026-01-31actual
Study first posted2026-03-12actual
Last update posted2026-03-12actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Adults (≥20 years) with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 identified from routinely collected electronic health record data in the TriNetX US Collaborative Network. Participants initiated a GLP-1 receptor agonist or an SGLT2 inhibitor and were classified according to early add-on treatment strategies.

Inclusion criteria

•Adults aged 20 years or older.
•Obesity, defined by body mass index (BMI) 27 kg/m2 or greater.
•Type 2 diabetes mellitus, defined using electronic health record data, including diagnosis codes and/or hemoglobin A1c 6.5% or greater.
•Met cardiovascular-kidney-metabolic (CKM) stage 2-3 criteria at baseline.
•Initiated a GLP-1 receptor agonist or an SGLT2 inhibitor as background therapy.
•Had treatment strategy classification based on early add-on initiation within 90 days after background therapy initiation, or no early add-on with index at the 90-day landmark.

Exclusion criteria

•Prior use of GLP-1 receptor agonists, SGLT2 inhibitors, DPP-4 inhibitors, or sulfonylureas within 6 months before cohort entry.
•Major cardiovascular disease or revascularization within 12 months before cohort entry.
•Advanced kidney disease within 12 months before cohort entry, including end-stage kidney disease, dialysis, or estimated glomerular filtration rate less than 15 mL/min/1.73 m2.
•Major cardiovascular or renal events within 6 months before index.
•Any history of non-type 2 diabetes, HIV infection, bariatric surgery, or solid-organ transplantation.
•Missing critical baseline covariates.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
2
Renal / kidney
1

Cardiovascular outcomes

2 endpoints
Primary/protocol endpoint

All-Cause Mortality

Time frame:From index through 36 months

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Major Adverse Cardiovascular Events (MACE)

Time frame:From index through 36 months

3-point MACE

composite event, event

componentsCardiovascular death, Myocardial infarction (any), Stroke (any)

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Major Adverse Kidney Events (MAKE)

Time frame:From index through 36 months

Custom renal composite

composite event, event

componentsEnd-stage renal disease, Kidney-replacement therapy, All-cause death

Publications (51)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.