A Retrospective Database Study to Compare Cardiovascular and Renal Outcomes of Ozempic® (OW Semaglutide) Versus Other Anti-Diabetic Drugs in Chinese T2D Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Time to 3P major adverse cardiovascular events
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Time to 3P major adverse cardiovascular events
时间窗: 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
时间窗: 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
时间窗: From index date to the first stroke event or censoring event (up to 36 months)
Measured in days.
Time to myocardial infarction (MI)
时间窗: From index date to the first MI event or censoring event (up to 36 months)
Measured in days.
Time to heart failure (HF)
时间窗: From index date to the first HF event or censoring event (up to 36 months)
Measured in days.
Time to composite renal event
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From index date to the first renal disease-related hospitalization or censoring event (up to 36 months)
Measured in Percentage, per 1000 patient year.
次要结局
- PDC in 12 months(From index date to Day 360)
- Proportion of days covered (PDC) in 6 months(From index date to Day 180)