NCT00846716

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Shiga University · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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 diabetic patients.

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 ratio (4)Change in GFR (5)CHange in cystatin C

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2009-02-19
• Last updated: 2009-02-19

Locations

1 site across 1 country: Japan