Incidence of Diabetic Ketoacidosis Among Patients With Type 2 Diabetes Mellitus Treated With SGLT2 Inhibitors or Other Antihyperglycemic Agents- A Retrospective, Observational, New-User Cohort Study Using 4 Administrative Claims Databases in the US
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200,000
- 主要终点
- Number of Participants with a recorded diagnosis of Diabetic Ketoacidosis (DKA)
研究概览
简要总结
The purpose of this study is to compare the incidence of diabetic ketoacidosis (DKA) among participants diagnosed with type 2 diabetes mellitus (T2DM) and pair-matched on exposure propensity scores for new use of any sodium-glucose co-transporter 2 inhibitors (SGLT2i) versus new use of various other antihyperglycemic agents (AHAs), combined as one group.
详细描述
This study will be an overall retrospective, observational, new-user cohort study using 4 large administrative claims databases in the US. Participants diagnosed with T2DM and initiated on SGLT2i or other AHAs (metformin, sulfonylureas (SU), thiazolidinediones (TZDs), DPP-4 inhibitors (DPP4i), GLP-1 agonists, insulin, and other AHAs) between April 1, 2013 and the end of claims data availability will be included in the study and will be estimated for incidence rates of DKA in the different AHA new-user groups.
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
- •At least 1 antihyperglycemic agents (AHA) prescription (Rx) during the study period, between 4/1/2013 and 9/30/
- •Diagnosed of type 2 diabetes mellitus
- •Enrollment history of at least 12 months
- •Having prescription drug coverage
- •Having no prescription of the index drug during the 6 months prior
排除标准
- •Participants who receive diagnosis of type1 diabetes mellitus (T1DM) and/or secondary diabetes mellitus (SDM) any time after index date.
研究组 & 干预措施
Cohort 1
Cohort 1 included participants who were exposed to sodium-glucose co-transporter 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin and empagliflozin).
干预措施: No Intervention (Drug)
Cohort 2
Cohort 2 included participants who were exposed to other non-SGLT2 antihyperglycemic agents (AHA).
干预措施: No Intervention (Drug)
结局指标
主要结局
Number of Participants with a recorded diagnosis of Diabetic Ketoacidosis (DKA)
时间窗: Day 1
次要结局
未报告次要终点