NCT00846716Unknown不适用
Exploratory Study to Investigate the Suppressive Effect of Oral Anti-Diabetic Drug (TZD) on Progression of Diabetic Nephropathy on
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Onset and progression of diabetic nephropathy
研究概览
简要总结
The purpose of this study is to investigate whether the oral anti-diabetic drug, Thiazolidine (TZD) is effective in suppression of onset or progressin of diabetic nephropathy in Japanese type 2 diabetic patients.
详细描述
-
Outcome measures:
-
Primary endpoint Onset or progression of diabetic nephropathy
-
Secondary endpoints (1)Progression of diabetes mellitus (2)Change in HbA1c (3)Change in albumin-creatinine ratio (4)Change in GFR (5)CHange in cystatin C
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus
- •Less than 8.0% in HbA1c
- •Less than 300 mg/g Cr of urinary albumine level
- •Concomitant therapy with SU and/or Biguanide
- •Untreated hypertension and hypertension treated with ARB or ACEI
排除标准
- •History of heart failure and concomitant heart failure
- •History of administration of TZD agent
- •Severe hepatic dysfunction with more than 3 times higher than upper limit of normal range of GOT, GPT or rGPT
- •Severe renal dysfunction with more than 2.5 of Cr
- •History of AE with TZD agent
- •Insulin treatment
- •Concomitant urinary track infection
研究组 & 干预措施
Pioglitazone add on to SU or biguanide
Experimental
干预措施: Pioglitazone add on to SU or biguanide (Drug)
SU or Biguanide
Active Comparator
干预措施: SU or Biguanide (Drug)
结局指标
主要结局
Onset and progression of diabetic nephropathy
时间窗: 2 years
次要结局
- Progression of diabetes mellitus change from the baseline in HbA1c change from the baseline in albumine/creatinine ratio change from the baseline in cystatin C onset and progression of diabetic retinopathy safety assessment(2 years)
研究者
研究点 (1)
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