SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 994
- 试验地点
- 7
- 主要终点
- Rate of decline in eGFR
研究概览
简要总结
The aim of the trial is to evaluate the effects of the SGLT2 inhibitor, dapagliflozin, compared to metformin on annual decline in eGFR when used as first line therapy in people with Type 2 Diabetes.
详细描述
This study is a randomised, double blinded clinical trial and will be undertaken in primary care and community sites across Australia and tertiary care centres in Sri Lanka. Following a 4-week active run-in period, eligible participants will be randomised to either dapagliflozin 10mg daily, or metformin XR 2000mg daily in a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 T2D;
- •Aged ≥18 years;
- •Body mass index > 18.5 kg/m2;
- •Drug naïve, or managed with metformin monotherapy and willing to be randomised to either dapagliflozin or metformin;
- •eGFR ≥45 ml/min/1,73m2; and
- •Signed informed consent.
排除标准
- •Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia; or
- •There is a definite indication for, or contraindication to, either metformin or SGLT2 inhibitor; or
- •They have clearly documented coronary artery disease (defined as a previous acute coronary syndrome, coronary stent or bypass surgery) or clearly documented heart failure (defined on the basis of a hospital admission, specialist diagnosis or an echocardiogram or other imaging modality); or
- •Pregnant or breast-feeding.
研究组 & 干预措施
Dapagliflozin 10mg
1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years
干预措施: Dapagliflozin (Drug)
Metformin XR 2000mg
2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years
干预措施: Metformin (Drug)
结局指标
主要结局
Rate of decline in eGFR
时间窗: 24 months
Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year
次要结局
- Urine albumin creatinine ratio(24 months)
- Serum creatinine(24 months)
- HbA1C(24 months)
- Fasting blood glucose(24 months)
- Systolic and diastolic blood pressure(24 months)
- Body weight(24 months)
- Quality of life measured by EQ-5D-5L(24 months)
- Anxiety and depression symptoms measured by HADS(24 months)