Database Linkage Study to Evaluate the Risk of Medullary Thyroid Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 93,600,000
- 试验地点
- 1
- 主要终点
- Time to first occurence of Medullary Thyroid Carcinoma (MTC)
研究概览
简要总结
This is a database linkage study utilizing real-world data (RWD) to determine whether certain medicines used to treat type 2 diabetes (T2D) and support weight management (called GLP-1 RAs (Glucagon-like peptide-1 receptor agonists )) are linked to an increased risk of a rare cancer called medullary thyroid carcinoma (MTC). The purpose of this study is to compare how often medullary thyroid cancer occurs in people taking these medicines versus those taking other similar treatments. This study will use dispensed prescription claims and State Cancer Registry data to assess the risk of MTC.
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
- •18 years or older during the year of index (date of qualifying medication)
- •In addition to index medication, greater than or equal to (≥) 1 dispensed medication (any class) within 24 months prior to the index date1
- •≥1 dispensed medication (any class) after the index date and within 12 months of index date (12-month post-index period)
- •No evidence of cohort qualifying medication during 12-month before the index date
- •Reside in the US, including the District of Columbia (DC) during the study period
- •No missing values for year of birth
排除标准
- •Patients with a diagnosis of MTC in the linked SCR data before their index date will not be included in the study.
研究组 & 干预措施
T2D Active Comparator 2 Cohort
Participants will be included in this cohort if they fill at least one dispensed prescription for any antidiabetic medications (including SGLT2 or DPP-4 inhibitors), other than LA GLP-1 RA therapies during the study patient selection period with no evidence of the cohort qualifying medication during the prior 12-month lookback period.
干预措施: No treatment given (Other)
Overweight/Obesity Active Comparator Cohort
Participants will be included in this cohort if they fill at least one dispensed prescription for anti-obesity medications, other than LA GLP-1 RA therapies during the study patient selection period with no evidence of the cohort qualifying medication during the prior 12-month lookback period.
干预措施: No treatment given (Other)
T2D Active Comparator 1 Cohort
Participants will be included in this cohort if they fill at least one dispensed prescription for SGLT2 or DPP-4 inhibitors during the study patient selection period with no evidence of SGLT2 or DPP-4 inhibitors and without LA GLP-1 RA use during the prior 12-month lookback period.
干预措施: No treatment given (Other)
Long-acting GLP-1 RA Exposed Cohort
Participants will be eligible for inclusion in this cohort if they have at least one dispensed prescription for a LA GLP-1 RA therapy during the study patient selection period.
干预措施: No treatment given (Other)
结局指标
主要结局
Time to first occurence of Medullary Thyroid Carcinoma (MTC)
时间窗: From day 1 up to 15 years
Measured in number of days.
次要结局
未报告次要终点