Shiga Progression of Diabetes, Nephropathy and Retinopathy
NCT ID: NCT00846716
Last Updated: 2009-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2008-03-31
2011-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pioglitazone add on to SU or biguanide
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.
SU or Biguanide
SU or Biguanide
As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.
Interventions
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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.
SU or Biguanide
As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
75 Years
ALL
No
Sponsors
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Kanazawa Medical University
OTHER
Nagahama Red Cross Hospital
OTHER
Nagahama City Hospital
OTHER
Kohka Public Hospital
UNKNOWN
Second Okamoto General Hospital
UNKNOWN
Omihachiman COmmunity Medical Center
UNKNOWN
Yasu Hospital
UNKNOWN
Toyosato Hospital
UNKNOWN
Ako City Hospital
OTHER
Horide Clinic
UNKNOWN
Kawabata Clinic
UNKNOWN
Seta Clinic
UNKNOWN
Shiga Clinic
UNKNOWN
Osaka University
OTHER
NTT West Osaka Hospital
UNKNOWN
Hyogo prefectural Amagasaki Hospital
UNKNOWN
Tomita Clinic
UNKNOWN
Sawada Clinic
UNKNOWN
Social Insurance Shiga Hospital
UNKNOWN
Shiga University
OTHER
Responsible Party
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Shiga University of Medical Science
Principal Investigators
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Atsunori Kashiwagi, PhD.
Role: STUDY_CHAIR
Tsukiwa-machi, Seta, Otsu, Shiga, Japan
Locations
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Shiga University of Medical Science
Ōtsu, Shiga, Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2008.9.18 ver2-4
Identifier Type: -
Identifier Source: org_study_id
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