Shiga Progression of Diabetes, Nephropathy and Retinopathy

Study Overview
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Brief Summary
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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
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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

Official Title
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Exploratory Study to Investigate the Suppressive Effect of Oral Anti-Diabetic Drug (TZD) on Progression of Diabetic Nephropathy on

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Pioglitazone add on to SU or biguanide
* Drug: SU or Biguanide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pioglitazone add on to SU or biguanide<br> | Drug: Pioglitazone add on to SU or biguanide<br>* As an initial dosing, 15mg/day of pioglitazone is administered to the patients for 2 years, who are taking SU or biguanide.<br>|
| Active Comparator: SU or Biguanide<br> | Drug: SU or Biguanide<br>* As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset and progression of diabetic nephropathy |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Diabetic Nephropathy, Diabetic Retinopathy, pioglitazone