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Enrolling by Invitation

NCT Number: NCT07456774

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Tianjin, Tianjin Municipality, 300074, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Time to stroke

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

    Measured in days.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Secondary outcomes

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

    Time frame: From index date to Day 180

    Measured in percentage.

  2. PDC in 12 months

    Time frame: From index date to Day 360

    Measured in percentage.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: SPOTLIGHT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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