Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan- for Dapagliflozin in Management of Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 511
- 试验地点
- 1
- 主要终点
- The mean change in HbAlc from mean baseline and at Month 12.
研究概览
简要总结
REWARD is an Non Interventional study aims to describe the changes in the clinical outcomes of Type 2 Diabetes Mellitus patients who are treated with Dapagliflozin for a period of one year including the fasting period of Ramadan
详细描述
REWARD is a multi-center, post-authorization, prospective, open label, non-interventional, real-life, observational, cohort study. The study is to be conducted at 10-15 sites .
Aims to describe the changes in the clinical outcomes over 1 year as follows:
- Primary Objective:
To describe the change in HbAlc from baseline as a parameter for blood glucose control. 2. Secondary Objective:
To describe the changes from baseline in the following parameters:
- Total body weight.
- Total cholesterol, LDL-C, non-HDL-C and triglycerides.
- Systolic and Diastolic Blood Pressures.
- Other Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The target population will be selected according to the following inclusion criteria:
- •Males and females participants aged 18 years and older who are diagnosed type 2 Diabetic patients- (Based on American Diabetes Association diagnostic criteria (ADA), The ADA defines diabetes as a fasting blood glucose (FBG) of ≥ 126mg/dL or a 2-hour glucose level post oral glucose tolerance test (OGTT) of ≥ 200 mg/dL or HbAJC of ≥ 6.5%).
- •Patients treated with Dapagliflozin (as per routine care and in compliance with the locally approved prescribing information) for ≥ 4 weeks and ≤ 16 weeks prior to the recruitment date.
- •Patients with CrCl > 60 ml/min or eGFR > 60 ml/min/1.73 m2 should be included in trial.
- •Patients providing written informed consent.
排除标准
- •Patients with contraindications to Dapagliflozin as per the locally approved prescribing information will be excluded from the study.
- •If participating in any clinical trial, the subject cannot take part in this study.
- •Patients with clinically significant renal, hepatic, haematological, oncological, endocrine, psychiatric or rheumatic disease.
- •Patients who don't have a disease with life expectancy under 1 year.
- •Patients with CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2 should be excluded from the trial.
结局指标
主要结局
The mean change in HbAlc from mean baseline and at Month 12.
时间窗: 12 Months
Primary Variable: To describe the change in HbAlc from baseline as a parameter for blood glucose controL
次要结局
- Changes from baseline in Total body weight(12 Months)
- Changes from baseline in non-HDL-C(12 Months)
- Changes from baseline in Total cholesterol(12 Months)
- Changes from baseline in Systolic Blood Pressures(12 Months)
- Changes from baseline in LDL-C(12 Months)
- Changes from baseline in triglycerides.(12 Months)
- Changes from baseline in Diastolic Blood Pressures(12 Months)