Shiga Progression of Diabetes, Nephropathy and Retinopathy

• Status: Unknown status
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shiga University
• Collaborators: Ako City Hospital; Horide Clinic; Hyogo prefectural Amagasaki Hospital; Kanazawa Medical University; Kawabata Clinic; Kohka Public Hospital; Nagahama City Hospital; Nagahama Red Cross Hospital; NTT West Osaka Hospital; Omihachiman COmmunity Medical Center; Osaka University; Sawada Clinic; Second Okamoto General Hospital; Seta Clinic; Shiga Clinic; Social Insurance Shiga Hospital; Tomita Clinic; Toyosato Hospital; Yasu Hospital
• Treatments: Biguanides; Pioglitazone

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