Shiga Progression of Diabetes, Nephropathy and Retinopathy

Exploratory Study to Investigate the Suppressive Effect of Oral Anti-Diabetic Drug (TZD) on Progression of Diabetic Nephropathy on

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.

2. Outcome measures:

1. Primary endpoint Onset or progression of diabetic nephropathy
2. 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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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