A Real World Experience of Dapagliflozin in Type 2 Diabetes
Dapaglifozin in Type 2 Diabetes Mellitus Patients: A Single-centre Retrospective Cohort Study
研究概览
地位
条件
详细说明
The prevalence of type 2 diabetes among adults >18 years old is 17.5% in Malaysia, where half of them are undiagnosed. Diabetes also accounts for 14.5% of all-cause mortality worldwide, with close to half of the deaths are in subjects <60 years old. These highlight the importance of early diagnosis of disease, timely intervention with appropriate therapy, and treating type 2 diabetes patients to goal to prevent the development of complications.
Asian type 2 diabetes phenotypes are different than Caucasians, i.e. significant pancreatic beta-cell dysfunction, higher visceral adiposity, more vulnerable to cardio-renal complications. Although clinical trials of SGLT-2 inhibitors have been published, real-world data on the use of this new class of antidiabetic medication is still lacking, in particularly among Asians.
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
All adult T2DM patients who received at least one prescription for dapagliflozin for the first time between March 2014 and December 2015 at the University of Malaya Medical Center (UMMC) will be recruited. UMMC is an academic medical institution with 1,300 beds, serving a population of 1.8 million in Kuala Lumpur, Malaysia.
The date of the first prescription for dapagliflozin in the Hospital Pharmacy Database is defined as the index date. Dapaglifozin is only available at the study site from March 2014 onwards.
描述
Inclusion Criteria:
- Diagnosis of T2DM prior to the first prescription of dapagliflozin
- Patients with T2DM who are initiated with dapagliflozin from March 2014 till December 2015
- Patients need to be on dapagliflozin therapy for at least six consecutive months from the index date
- Patients need to have diabetologists/endocrinologists' follow up for at least six months after the initiation of dapagliflozin
Exclusion Criteria:
- Patients with T2DM who are initiated with dapagliflozin after December 2015
- Patients with incomplete electronic medical records
- Patients with Type 1 diabetes
- Patients with latent autoimmune diabetes of adults (LADA)
- Female Patients with T2DM who are found to be pregnant during the treatment period of dapagliflozin
学习计划
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：追溯
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in HbA1c
大体时间：6 months
|
To assess the change in HbA1c from baseline to 6 months
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in body weight
大体时间：6 months
|
To assess the change in body weight from baseline to 6 months
|
6 months
|
|
Change in estimated glomerular filtration rate
大体时间：6 months
|
To assess the change in estimates glomerular filtration rate from baseline to 6 months
|
6 months
|
|
Change in albuminuria
大体时间：6 months
|
To assess the change in albuminuria from baseline to 6 months
|
6 months
|
|
Change in body mass index
大体时间：6 months
|
To assess the change in body mass index from baseline to 6 months
|
6 months
|
合作者和调查者
调查人员
- 首席研究员：Lee Ling LIM, MRCP (UK)、University of Malaya, Malaysia
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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