KCT0002681招募中未知
A multicenter, randomized, open, parallel, prospective study to investigate the effectiveness of 50mg gemigliptin on diabetic retinopathy in patients with type 2 diabetes
Ajou University Hospital0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1) Age 20-80 years
- •2) Type 2 diabetes
- •3) HbA1c 7%=HbA1c=10%
- •4) BMI 20-35 kg/m2
- •5) background medications: metformin 500~2000mg, glimepiride = 4mg/day, or gliclazide = 60mg/day
- •6) mild to moderate non-proliferative diabetic retinopathy (ETDRS 20-43, microaneurysm or mild to moderate NPDR)
- •7) A person who is able to complete the written consent before the start of the clinical trial and comply with the requirements of the clinical trial
排除标准
- •1) Type 1 diabetes or patients with acute or chronic metabolic acidosis and history of diabetic ketoacidosis
- •2) patients requiring ophthalmologic treatment with macular edema (central foveal thickness of > 275 µm on OCT) or severe NPDR
- •3) proliferative diabetic retinopathy
- •4) patients with receiving intraocular surgery or vitreoretinal pathyology
- •5) DPPIV inhibitor, GLP-1 agonist, or fibrate user within 8 weeks
- •6) hypersensitivity or intolerance of gemigliptin, glimepiride, gliclazide, or metformin
- •7) history of angioedema by ACE inhibitor or ARB or history of diabetic gastroparesis
- •8) cardiovascular disease within 6 months
- •9) chronic kidney disease (creatinine clearance rate <30mL/min)
- •10) chronic hepatitis B or C (excluding healthy carrier) or liver disease (screening test : ALT < 2.5 x ULN, AST < 2.5 x ULN, ALK < 2.5 x ULN, T.bilirubin <2.5 x ULN)
- •11) genetic disease (Galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome)
- •12) cerebrovascular disease within 6 months
- •13) alcohol or drug abuser within 3 months
- •14) cancer within
- •15) pregnant or lactating women
- •17) patients who was judged to be unfit for clinical trial
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