Status:
UNKNOWN
Shiga Progression of Diabetes, Nephropathy and Retinopathy
Lead Sponsor:
Shiga University
Collaborating Sponsors:
Kanazawa Medical University
Nagahama Red Cross Hospital
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
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 diabet...
Detailed Description
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00846716
Start Date
March 1 2008
End Date
November 1 2011
Last Update
February 19 2009
Active Locations (1)
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1
Shiga University of Medical Science
Ōtsu, Shiga, Japan, 520-2192