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Type 2 DiabetesSPOTLIGHTNCT07456774

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

An observational study of Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The study is testing the incidence of MACE and incidence of renal events between Ozempic® users and users with other anti-diabetic medications in T2D patients. This is a retrospective study, and participants had received Ozempic or any other anti-diabetic medications. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
How many people
100,000 participants
Where
1 siteChina
Study dates
13 Feb 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: Participants received Ozempic (semaglutide) and any other prescribed anti-diabetic medication(s).

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

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

China1 site
  • NIS- Tianjin Medical University Chu Hsien-I Memorial Hospital-Department of Endocrinology

    Tianjin, Tianjin Municipality, 300074

Other trials in China

About this study

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

The study is testing the incidence of MACE and incidence of renal events between Ozempic® users and users with other anti-diabetic medications in T2D patients. This is a retrospective study, and participants had received Ozempic or any other anti-diabetic medications.

Conditions
Type 2 Diabetes
Medical subject headings
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 NCT07456774
Study groupRoleWhat they receive
Ozempic usersThis cohort includes the participants who received Ozempic (semaglutide) as prescribed.
Non-Ozempic usersThis cohort includes the participants who received other anti-diabetic medication(s) as prescribed.

What is being measured

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

  1. Time to 3P major adverse cardiovascular events

    Measured in days.

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

  2. Time to 5P MACE

    Measured in days.

    Measured: 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)

  3. Time to stroke

    Measured in days.

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

  4. Time to myocardial infarction (MI)

    Measured in days.

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

  5. Time to heart failure (HF)

    Measured in days.

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

  6. Time to composite renal event

    Measured in days.

    Measured: 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)

  7. Time to renal disease-related hospitalization

    Measured in days.

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

  8. Incidence rate of 3P MACE

    Measured in Percentage, per 1000 patient year.

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

  9. Incidence rate of 5P MACE

    Measured in Percentage, per 1000 patient year.

    Measured: 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)

  10. Incidence rate of stroke

    Measured in Percentage, per 1000 patient year.

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

  11. Incidence rate of myocardial infarction

    Measured in Percentage, per 1000 patient year.

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

  12. Incidence rate of heart failure

    Measured in Percentage, per 1000 patient year.

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

  13. Incidence rate of composite renal event

    Measured in Percentage, per 1000 patient year.

    Measured: 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)

  14. Incidence rate of renal disease-related hospitalization

    Measured in Percentage, per 1000 patient year.

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

Secondary outcomes (2)
  1. Proportion of days covered (PDC) in 6 months

    Measured in percentage.

    Measured: From index date to Day 180

  2. PDC in 12 months

    Measured in percentage.

    Measured: From index date to Day 360

Timeline

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

  1. First posted6 Mar 2026
  2. Study start13 Feb 2026
  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
100,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07456774
Sponsor's protocol ID
NN9535-8602
Acronym
SPOTLIGHT
Status last verified
May 2026
First submitted
9 Feb 2026
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in China.

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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 20 May 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 China. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 May 2026.

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