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:
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
As an initial dosing, 15mg/day of pioglitazone is administered to the patients for 2 years, who are taking SU or biguanide.
As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.
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