Trial | NCT00846716  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    400
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
Study Started
Mar 31
2008
Primary Completion
Nov 30
2011
Anticipated
Study Completion
Nov 30
2011
Anticipated
Last Update
Feb 19
2009
Estimate

Drug Pioglitazone add on to SU or biguanide

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

Drug SU or Biguanide

As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.

Pioglitazone add on to SU or biguanide Experimental

SU or Biguanide Active Comparator

Criteria 

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
No Results Posted