Real-world Study of CHina Ozempic cLinicAl pRactice in Patients With Type 2 Diabetes (SCHOLAR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34,238
- 试验地点
- 1
- 主要终点
- Change in HbA1c level
研究概览
简要总结
This study is to describe the real-world use and impact of semaglutide once-weekly (OW) among participants with type 2 diabetes mellitus (T2DM) in China. Participants diagnosed with T2DM who initiated semaglutide OW for the first time between 1 Jan 2022 (the date when semaglutide OW was listed in the National Reimbursement Drug List [NRDL] in China] and 28 Feb 2023 (9 months prior to the data extraction cut-off date of 30 Nov 2023) will be included in this study. The study period will be 36 months prior to the first date of participants identification period.
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
- •Male or female participants aged greater than or equal to (≥) 18 years on index date
- •Participants with diagnosis of T2DM prior to or on index date
- •Participants with initiation of semaglutide OW for the first time within the identification period
排除标准
- •Participants with diagnosis of type 1 diabetes prior to or on index date
- •Participants who were pregnant within 36 months prior to or on index date
- •Participants who participated in any clinical trials within 36 months prior to or on index date which could be identified from medical records
研究组 & 干预措施
Participants with T2DM
Participants diagnosed with T2DM who initiated semaglutide OW for the first time between 1 Jan 2022 (the date when semaglutide OW was listed in the National Reimbursement Drug List [NRDL] in China) and 28 Feb 2023 (9 months prior to the data extraction cut-off date of 30 Nov 2023.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in HbA1c level
时间窗: From baseline (3 months prior to or on the index date) to 6 months
Measured in millimoles per mol (mmol/mol)
Change in Haemoglobin A1c (HbA1c) level
时间窗: From baseline (3 months prior to or on the index date) to 6 months
Measured in Percentage (%).
Proportion of participants achieving HbA1c less than (<) 7.0%
时间窗: At 6 months
Measured in percentage of participants.
次要结局
- Description of participants with different clinical characteristics(At baseline (36 months prior to or on the index date))
- Change in HbA1c level(From baseline (3 months prior to or on the index date) to 12 months)
- Proportion of participants achieving HbA1c <7.0%(At 12 months)
- Change in body weight(From baseline (3 months prior to or on the index date) to 6 months)
- Proportion of participants with different antidiabetic medications(At baseline (3 months prior to or on the index date))
- Proportion of participants with different non-antidiabetic medications(At baseline (3 months prior to or on the index date))
- Description of participants with different demographic characteristics(At baseline (12 months prior to or on the index date))