NCT07424430尚未招募不适用
Real-world Canadian Retrospective Study Evaluating Longitudinal SEMAglutide Use on Cardio-Kidney-Metabolic Outcomes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Change in HbA1c- 3 Years
研究概览
简要总结
The goal of this study is to better understand the real-world effectiveness of semaglutide use on cardio-kidney-metabolic outcomes among adults with T2D and adults with obesity (without diabetes mellitus). This is a retrospective longitudinal analysis using the LMC Diabetes Registry. The primary outcome of the study is to evaluate the change in HbA1c between baseline to 3 years of follow-up among adults with T2D who initiated semaglutide compared to adults with T2D who initiated other AHAs, including sulfonylurea, dipeptidyl peptidase-4 inhibitors, and sodium-glucose cotransporter-2 inhibitors.
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
- •T2D Cohort:
- •A clinical diagnosis of T2D ≥ 1 year
- •HbA1c ≥ 6.5% (pre-index date)
- •Initiated semaglutide or other AHA(s) before January 1st, 2023*
- •Seen by an LMC endocrinologist in the last 18 months as of the query date
- •≥ one HbA1c value up to 6 months (+ 90 days) prior to index date
- •Informed data consent for their medical record data to be used for research purposes
- •Obesity Cohort:
- •18 years or older
- •BMI ≥ 27 kg/m2
- •HbA1c < 6.5% (pre-index date)
- •Initiated semaglutide before January 1st, 2023*
- •Seen by an LMC endocrinologist in the last 18 months as of the query date
- •≥ one HbA1c value up to 6 months (± 90 days) prior to index date
- •Informed data consent for their medical record data to be used for research purposes
排除标准
- •Clinical diagnosis of type 1 diabetes/latent autoimmune diabetes in adults (LADA)
- •Clinical diagnosis of T2D (obesity cohort only)
- •Are pregnant at the time of semaglutide or other AHA initiation or became pregnant during follow-up period
- •Documented history or family history of medullary thyroid carcinoma
- •Participation in a research study with an Investigational Product
- •eGFR < 15 mL/min/1.73m2 at index date
- •Use of non-semaglutide GLP-1-based medication for more than 6 months after the index date (T2D sema cohort and obesity sema cohort)
- •Use of other AHA for more than 6 months after the index date within the first year of semaglutide use (T2D sema cohort and obesity sema cohort)
研究组 & 干预措施
T2D other AHA cohort
Adults with T2D prescribed antihyperglycemic medication beside semaglutide including sulfonylurea, DPP4i, and/or SGLT2i
Obesity Semaglutide Cohort
Adults with obesity, defined as BMI equal or greater than 27 kg/m2, prescribed semaglutide
干预措施: Semaglutide (SEMA) (Drug)
T2D Semaglutide Cohort
Adults with T2D prescribed semaglutide
干预措施: Semaglutide (SEMA) (Drug)
结局指标
主要结局
Change in HbA1c- 3 Years
时间窗: Baseline to 3 Years
The primary outcome measure is investigating the change in HbA1c from baseline to 3 years (± 90 days) among adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs
次要结局
- Change in HbA1c- 1 Year(Baseline to 1 year)
- Change in HbA1c- 2 Years(Baseline to 2 Years)
- Proportion of individuals who achieve HbA1c ≤ 7.0% - 1 Year(Baseline to 1 Year)
- Proportion of individuals who achieve HbA1c ≤ 7.0%- 2 Years(Baseline to 2 Years)
- Proportion of individuals who achieve HbA1c ≤ 7.0% - 3 Years(Baseline to 3 Years)
- Change in body weight- 1 Year(Baseline to 1 Year)
- Change in body weight- 2 Years(Baseline to 2 Years)
- Change in body weight- 3 Years(Baseline to 3 Years)
- Percent body weight loss ≥ 5% - 1 Year(Baseline to 1 Year)
- Percent body weight loss ≥ 5% - 2 Years(Baseline to 2 Years)
- Percent body weight loss ≥ 5% - 3 Years(Baseline to 3 Years)
- Percent body weight loss ≥ 10% - 1 Year(Baseline to 1 Year)
- Percent body weight loss ≥ 10% - 2 Years(Baseline to 2 Years)
- Percent body weight loss ≥ 10% - 3 Years(Baseline to 3 Years)
- Percent body weight loss ≥ 15% - 1 Year(Baseline to 1 Year)
- Percent body weight loss ≥ 15%- 2 Years(Baseline to 2 Years)
- Percent body weight loss ≥ 15%- 3 Years(Baseline to 3 Years)
- Change in BMI- 1 Year(Baseline to 1 Year)
- Change in BMI- 2 Years(Baseline to 2 Years)
- Change in BMI- 3 Years(Baseline to 3 Years)
- Change in Waist Circumference- 1 Year(Baseline to 1 Year)
- Change in Waist Circumference- 2 Years(Baseline to 2 Years)
- Change in Waist Circumference- 3 Years(Baseline to 3 Years)
- Change in Blood Pressure- 1 Year(Baseline to 1 Year)
- Change in Blood Pressure- 2 Years(Baseline to 2 Years)
- Change in Blood Pressure- 3 Years(Baseline to 3 Years)
- Change in eGFR- 1 Year(Baseline to 1 Year)
- Change in eGFR- 2 Years(Baseline to 2 Years)
- Change in eGFR- 3 Years(Baseline to 3 Years)
- Proportion of individuals with ≥ 50% decline in eGFR- 1 Year(Baseline to 1 Year)
- Proportion of individuals with ≥ 50% decline in eGFR- 2 Years(Baseline to 2 Years)
- Proportion of individuals with ≥ 50% decline in eGFR- 3 Years(Baseline to 3 Years)
- Change in uACR- 1 year(Baseline to 1 Year)
- Change in uACR- 2 years(Baseline to 2 Years)
- Change in uACR- 3 Years(Baseline to 3 Years)
- Change in ALT- 1 Year(Baseline to 1 Year)
- Change in ALT- 2 Years(Baseline to 2 Years)
- Change in ALT- 3 Years(Baseline to 3 Years)
- Change in Lipids- 1 Year(Baseline to 1 Year)
- Change in Lipids- 2 Years(Baseline to 2 Years)
- Change in Lipids- 3 Years(Baseline to 3 Years)
- Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 1 Year(Baseline to 1 Year)
- Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 2 Years(Baseline to 2 Years)
- Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 3 Years(Baseline to 3 Years)
- Number of non-semaglutide GLP-1-based therapies- 1 Year(Baseline to 1 Year)
- Number of non-semaglutide GLP-1-based therapies- 2 Years(Baseline to 2 Years)
- Number of non-semaglutide GLP-1-based therapies- 3 Years(Baseline to 3 Years)
- Change in insulin use- 1 Year(Baseline to 1 Year)
- Change in Insulin- 2 Years(Baseline to 2 Years)
- Change in Insulin- 3 Years(Baseline to 3 Years)
- Change in TDD of insulin- 1 Year(Baseline to 1 Year)
- Change in TDD of insulin- 2 Years(Baseline to 2 Years)
- Change in TDD of insulin- 3 Years(Baseline to 3 Years)
- Incidence of non-acetylsalicylic acid antiplatelet use(Baseline to Endpoint)
- Percent body weight loss ≥ 5%(Baseline to 1 Year)
- Percent body weight loss ≥ 10%(Baseline to 1 Year)
- Percent body weight loss ≥ 15%(Baseline to 1 Year)
- Body Weight(Baseline to 1 Year)
- BMI(Baseline to 1 Year)
- Waist Circumference(Baseline to 1 Year)
- HbA1c(Baseline to 1 Year)
- Percent of new onset pre-diabetes(Baseline to 1 Year)
- Percent of new onset T2D(Baseline to 1 Year)
- Blood Pressure(Baseline to 1 Year)
- eGFR(Baseline to 1 year)
- uACR(Baseline to 1 Year)
- ALT(Baseline to 1 Year)
- Lipids(Baseline to 1 Year)
研究者
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