Clinical Trials in China / NCT07456774
Enrolling by invitation
Observational
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
NCT07456774 · tracked via the Priya Life Science China tracker
Condition(s) studied
Type 2 Diabetes
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Time to 3P major adverse cardiovascular events — 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 — 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 — From index date to the first stroke event or censoring event (up to 36 months)
Measured in days. - Time to myocardial infarction (MI) — From index date to the first MI event or censoring event (up to 36 months)
Measured in days. - Time to heart failure (HF) — From index date to the first HF event or censoring event (up to 36 months)
Measured in days. - Time to composite renal event — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — From index date to the first renal disease-related hospitalization or censoring event (up to 36 months)
Measured in Percentage, per 1000 patient year.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| NIS- Tianjin Medical University Chu Hsien-I Memorial Hospital-Department of Endocrinology | Tianjin | Tianjin Municipality |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07456774 on ClinicalTrials.gov ↗ ← All trials in China