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.
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
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 group | Role | What they receive |
|---|---|---|
| Ozempic users | This cohort includes the participants who received Ozempic (semaglutide) as prescribed. | |
| Non-Ozempic users | This 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.
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)
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)
Time to stroke
Measured in days.
Measured: From index date to the first stroke event or censoring event (up to 36 months)
Time to myocardial infarction (MI)
Measured in days.
Measured: From index date to the first MI event or censoring event (up to 36 months)
Time to heart failure (HF)
Measured in days.
Measured: From index date to the first HF event or censoring event (up to 36 months)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Proportion of days covered (PDC) in 6 months
Measured in percentage.
Measured: From index date to Day 180
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.
- First posted6 Mar 2026
- Study start13 Feb 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07456774
- Acronym / sponsor ID
- SPOTLIGHT / NN9535-8602
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozempic users | – | –This cohort includes the participants who received Ozempic (semaglutide) as prescribed. |
| Non-Ozempic users | – | –This cohort includes the participants who received other anti-diabetic medication(s) as prescribed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants received Ozempic (semaglutide) and any other prescribed anti-diabetic medication(s).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Measured in days.
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)
Measured in days.
Time to stroke
Time frame: From index date to the first stroke event or censoring event (up to 36 months)
Measured in days.
Time to myocardial infarction (MI)
Time frame: From index date to the first MI event or censoring event (up to 36 months)
Measured in days.
Time to heart failure (HF)
Time frame: From index date to the first HF event or censoring event (up to 36 months)
Measured in days.
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)
Measured in days.
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)
Measured in days.
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)
Measured in Percentage, per 1000 patient year.
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)
Measured in Percentage, per 1000 patient year.
Incidence rate of stroke
Time frame: From index date to the first stroke event or censoring event (up to 36 months)
Measured in Percentage, per 1000 patient year.
Incidence rate of myocardial infarction
Time frame: From index date to the first MI event or censoring event (up to 36 months)
Measured in Percentage, per 1000 patient year.
Incidence rate of heart failure
Time frame: From index date to the first HF event or censoring event (up to 36 months)
Measured in Percentage, per 1000 patient year.
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)
Measured in Percentage, per 1000 patient year.
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)
Measured in Percentage, per 1000 patient year.
2 secondary outcomes
Proportion of days covered (PDC) in 6 months
Time frame: From index date to Day 180
PDC in 12 months
Time frame: From index date to Day 360
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
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.