Effect of Gemigliptin on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Nephropathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 3
- 主要终点
- Markers of renal injury
研究概览
简要总结
Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and contain pleiotropic actions on kidney injury, albuminuria and vascular inflammation especially in animal models. We plan to evaluate the efficacy of potent DPP4-inhibitors (gemigliptin) in response to these aspects in diabetic nephropathy patients.
详细描述
This is a multi-center, prospective, randomized, placebo-controlled trial. A total of 201 participants were enrolled and randomly assigned to gemigliptin 50 mg daily and standard care of diabetes mellitus for 6 months. The changes of coronary calcium score (CAC score), cardio-ankle vascular index (CAVI), estimated glomerular filtration rate (GFR), markers of vascular calcification and markers of tubular renal injury were evaluated at baseline and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CKD stage 1-3 (eGFR 15-60 ml/min/1.73mL)
- •Non-insulin dependent diabetes mellitus , blood glucose level 30-250 mg/dL
- •Had clinical features compatible with diabetic nephropathy (urine micro albuminuria > 30 g/g creatinine or has evidence of diabetic retinopathy
排除标准
- •History of allergy to DPP4-inhibitor
- •Concurrent infectious disease
- •Inflammatory diseases
- •Post kidney transplantation
- •Receiving cinacalcet, bisphosphonate ,previously treated with DPP4-Inhibitors and sodium-glucose cotransporter-2 inhibitor (SGLT2-i).
研究组 & 干预措施
Gemigliptin group
The participants will receive gemigliptin 50 mg daily
干预措施: Gemigliptin (Drug)
Control
The control received standard care of diabetes
干预措施: Gemigliptin (Drug)
结局指标
主要结局
Markers of renal injury
时间窗: 6 months
eGFR (mL/min/1.73m2)
Markers of vascular calcification
时间窗: 6 months
CAVI,CAC score(unit) ,CAVI normal less than8 ,CAC score normal less than 100
次要结局
未报告次要终点
研究者
Thananda Trakarnvanich
Associate Professor
Bangkok Metropolitan Administration Medical College and Vajira Hospital