Dapaglifozin in Type 2 Diabetes Mellitus Patients: A Single-centre Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 主要终点
- Change in HbA1c
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) is creating a health pandemic globally. Management of type 2 diabetes involves combination of lifestyle intervention and drug intervention, which includes sodium-glucose transporter 2 (SGLT-2) inhibitors, such as dapagliflozin. Dapagliflozin (Forxiga®) was approved by the Malaysian Drug Authority for the treatment of type 2 diabetes in 2014. This study will describe the characteristics of patients who are prescribed dapagliflozin by diabetologists/endocrinologists in a tertiary referral center and describe their glycaemic control, weight, and renal function at baseline and during use of dapagliflozin.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •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
排除标准
- •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
结局指标
主要结局
Change in HbA1c
时间窗: 6 months
To assess the change in HbA1c from baseline to 6 months
次要结局
- Change in body weight(6 months)
- Change in estimated glomerular filtration rate(6 months)
- Change in albuminuria(6 months)
- Change in body mass index(6 months)