Efficacy and Safety of Dapagliflozin in progression of Chronic Kidney Disease in patients with type 2 Diabetes Mellitus: A Randomised Controlled Study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Maulana Azad Medical College Delhi
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in eGFR
概览
简要总结
Chronic Kidney Disease is highly prevalent at 17.2% in the Indian population and prevalence of CKD in Diabetes patients is 25%. It is irreversible, progressive disorder and is associated with high cardiovascular risk. The common causes for CKD include Diabetes, Hypertension, chronic use of NSAIDs, Chronic glomerulonephritis etc. Long standing or uncontrolled Diabetes has been associated with development of CKD.
Current management for retarding the progression of CKD is linked with control of Diabetes, hypertension and other complications. Angiotensin Converting Enzyme inhibitors, Angiotensin II receptor blockers, phosphate binders etc are presently being prescribed to slow down the progression.
Dapagliflozin is a reversible inhibitor of the Sodium Glucose co transporter 2 (SGLT2), which is responsible for glucose reabsorption in the kidney. It is highly selective drug which acts directly by elimination of glucose and thereby reducing blood glucose levels in type 2 Diabetes patients.
Dapagliflozin acts by restoration of tubuloglomerular feedback, recing workload by restricting the reabsorption and mitigating hypoxia.
It would be useful to know efficacy and safety of Dapagliflozin in slowing the progression of CKD in patients with Diabetes in Indian population. Hence, we propose to do this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with diagnosis of CKD with type 2 Diabetes Mellitus with HbA1c<8% who had- eGFR of 30-60ml/min/1.73m2 Urinary Albumin to Creatinine ratio 200-5000mg/g
- •Patients who are on ACE inhibitors or ARBs for at least 4 weeks before screening.
排除标准
- •Patients with Type 1 diabetes, lupus nephritis, Rheumatoid arthritis, Cancer and Neurodegenerative disorders
- •Patients have received immunosuppressive therapy within 6 months.
- •Pregnant patients and nursing mothers.
结局指标
主要结局
Change in eGFR
时间窗: 0, 3, 6 months after starting drug therapy
Change in UACR
时间窗: 0, 3, 6 months after starting drug therapy
次要结局
- Safety Profile in both groups(0, 3, 6 months after starting drug therapy)
- Frequency of hypoglycemic episodes
- Change in IL-6 levels
- Change in HbA1c levels(0, 3, 6 months after starting drug therapy)