Shiga Progression of Diabetes, Nephropathy and Retinopathy

Not Applicable

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Pioglitazone add on to SU or biguanide; Drug: SU or Biguanide

• Registration Number: NCT00846716
• Lead Sponsor: Shiga University

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 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

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-12-11
• Status Verified: 2009-02
• Study First Submitted QC: 2009-02-18
• Last Update Submitted: 2009-02-18
• Study First Posted: 2009-02-19
• Last Update Posted: 2009-02-19
• Primary Completion: 2011-11
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pioglitazone add on to SU or biguanide	Pioglitazone add on to SU or biguanide	-
SU or Biguanide	SU or Biguanide	-

Primary Outcome Measures

Name	Time	Method
Onset and progression of diabetic nephropathy	2 years

Secondary Outcome Measures

Name	Time	Method
Progression of diabetes mellitus change from the baseline in HbA1c change from the baseline in albumine/creatinine ratio change from the baseline in cystatin C onset and progression of diabetic retinopathy safety assessment	2 years

Trial Locations

Locations (1)

Shiga University of Medical Science; 🇯🇵 Otsu, Shiga, Japan