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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to 3P major adverse cardiovascular events | Measured in days. | 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. | 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. | From index date to the first stroke event or censoring event (up to 36 months) |
| Time to myocardial infarction (MI) | Measured in days. | From index date to the first MI event or censoring event (up to 36 months) |
| Time to heart failure (HF) | Measured in days. | From index date to the first HF event or censoring event (up to 36 months) |
| Time to composite renal event | Measured in days. | 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. | From index date to the first renal disease-related hospitalization or censoring event (up to 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of days covered (PDC) in 6 months | Measured in percentage. | From index date to Day 180 |
| PDC in 12 months | Measured in percentage. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants received Ozempic (semaglutide) and any other prescribed anti-diabetic medication(s).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS- Tianjin Medical University Chu Hsien-I Memorial Hospital-Department of Endocrinology | Tianjin | Tianjin Municipality | 300074 | China |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| Incidence rate of 3P MACE | Measured in Percentage, per 1000 patient year. | 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. | 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. | 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. | 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. | 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. | 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. | From index date to the first renal disease-related hospitalization or censoring event (up to 36 months) |
| From index date to Day 360 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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