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SPOTLIGHT

Enrolling by invitation

A Two-armed Real-world Study of Ozempic (OW Semaglutide) to Evaluate Its Adherence and Persistence Compared With Other Anti-diabetic Drugs Among Adult T2DM Patients in China

A Retrospective Database Study to Compare Cardiovascular and Renal Outcomes of Ozempic® (OW Semaglutide) Versus Other Anti-Diabetic Drugs in Chinese T2D Patients

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

100,000

estimated

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoints

Expanded / custom MACE composite (Stroke (any), Myocardial infarction (any), All-cause death)5-point MACE (Non-fatal stroke, Non-fatal MI, All-cause death, Heart-failure hospitalization)Stroke (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07456774
Org study IDNN9535-8602

Timeline

Milestones

Study start2026-02-13actual
Study first posted2026-03-06actual
Last update posted2026-05-20actual
Primary completion2026-08-31estimated
Study completion2026-08-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Participants received Ozempic (semaglutide) and any other prescribed anti-diabetic medication(s).

Inclusion criteria

Participants had at least one prescription for Ozempic® or other interested anti-diabetic medications during the index identification period.
Participants had at least one diagnosis of T2D, and had at least one of the three following T2D clinical evidence any time before or on the index date
Participants had at least 1 all-cause visit record any time after 6 months post-index date.
At least 18 years old at the index date.

Exclusion criteria

Patients who have used any same anti-diabetic medications as the index treatment within 6 months before index date (e.g., patient prescribed with any Ozempic® during baseline will be excluded if the index drug is a Ozempic®)
Patients with any diagnosis record of type 1 diabetes or gestational diabetes during whole study period.
Patients who were pregnant during the whole study period.
Patients who participated in any clinical trials during the whole study period.
Patients who were diagnosed with medullary thyroid carcinoma or multiple endocrine neoplasia type II (MEN2) during the whole study period.

Endpoints (16)

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
8
Renal / kidney
4
Heart failure
2
Other (unclassified)
2

Cardiovascular outcomes

8 endpoints
Primary/protocol endpoint

Time to 3P major adverse cardiovascular events

Time frame:From index date to the first composite 3P MACE (stroke, myocardial infarction, all-cause death) event or censoring event (up to 36 months)

Expanded / custom MACE composite

time to event, event

componentsStroke (any), Myocardial infarction (any), All-cause death

Primary/protocol endpoint

Time to 5P MACE

Time frame:From index date to the first composite 5P MACE (stroke, myocardial infarction, all-cause death, heart failure hospitalization, coronary revascularization) event or censoring event (up to 36 months)

5-point MACE

time to event, event

componentsNon-fatal stroke, Non-fatal MI, All-cause death, Heart-failure hospitalization, Coronary revascularization

Primary/protocol endpoint

Time to stroke

Time frame:From index date to the first stroke event or censoring event (up to 36 months)

Stroke (any)

time to event, event

SNOMED 230690007

Primary/protocol endpoint

Time to myocardial infarction (MI)

Time frame:From index date to the first MI event or censoring event (up to 36 months)

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Primary/protocol endpoint

Incidence rate of 3P MACE

Time frame:From index date to the first composite 3P MACE (stroke, myocardial infarction, all-cause death) event or censoring event (up to 36 months)

Expanded / custom MACE composite

time to event, event

componentsStroke (any), Myocardial infarction (any), All-cause death

Primary/protocol endpoint

Incidence rate of 5P MACE

Time frame:From index date to the first composite 5P MACE (stroke, myocardial infarction, all-cause death, heart failure hospitalization, coronary revascularization) event or censoring event (up to 36 months)

5-point MACE

time to event, event

componentsNon-fatal stroke, Non-fatal MI, All-cause death, Heart-failure hospitalization, Coronary revascularization

Primary/protocol endpoint

Incidence rate of stroke

Time frame:From index date to the first stroke event or censoring event (up to 36 months)

Stroke (any)

time to event, event

SNOMED 230690007

Primary/protocol endpoint

Incidence rate of myocardial infarction

Time frame:From index date to the first MI event or censoring event (up to 36 months)

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Heart failure

2 endpoints
Primary/protocol endpoint

Time to heart failure (HF)

Time frame:From index date to the first HF event or censoring event (up to 36 months)

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Primary/protocol endpoint

Incidence rate of heart failure

Time frame:From index date to the first HF event or censoring event (up to 36 months)

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Renal / kidney

4 endpoints
Primary/protocol endpoint

Time to composite renal event

Time frame:From index date to first composite renal (kidney failure: dialysis/transplantation/eGFR <15, ≥50% eGFR reduction from baseline, or kidney-related/cardiovascular death) or censoring event (up to 36 months)

Custom renal composite

time to event, event

componentsEnd-stage renal disease, Kidney-replacement therapy, eGFR, change, Renal death, Cardiovascular death

Primary/protocol endpoint

Time to renal disease-related hospitalization

Time frame:From index date to the first renal disease-related hospitalization or censoring event (up to 36 months)

time to event, event

Primary/protocol endpoint

Incidence rate of composite renal event

Time frame:From index date to first composite renal (kidney failure: dialysis/transplantation/eGFR <15, ≥50% eGFR reduction from baseline, or kidney-related/cardiovascular death) or censoring event (up to 36 months)

Custom renal composite

composite event, event

componentsEnd-stage renal disease, eGFR, change, Renal death, Cardiovascular death

Primary/protocol endpoint

Incidence rate of renal disease-related hospitalization

Time frame:From index date to the first renal disease-related hospitalization or censoring event (up to 36 months)

time to event, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint

Proportion of days covered (PDC) in 6 months

Time frame:From index date to Day 180

descriptive

Secondary/protocol endpoint/low confidence

PDC in 12 months

Time frame:From index date to Day 360

descriptive

Publications (4)

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.