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Shiga Progression of Diabetes, Nephropathy and Retinopathy (SHIP-DINER)

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ClinicalTrials.gov Identifier: NCT00846716
Recruitment Status : Unknown
Verified February 2009 by Shiga University.
Recruitment status was:  Recruiting
First Posted : February 19, 2009
Last Update Posted : February 19, 2009
Sponsor:
Collaborators:
Kanazawa Medical University
Nagahama Red Cross Hospital
Nagahama City Hospital
Kohka Public Hospital
Second Okamoto General Hospital
Omihachiman COmmunity Medical Center
Yasu Hospital
Toyosato Hospital
Ako City Hospital
Horide Clinic
Kawabata Clinic
Seta Clinic
Shiga Clinic
Osaka University
NTT West Osaka Hospital
Hyogo prefectural Amagasaki Hospital
Tomita Clinic
Sawada Clinic
Social Insurance Shiga Hospital
Information provided by:
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: Pioglitazone add on to SU or biguanide Drug: SU or Biguanide

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Study to Investigate the Suppressive Effect of Oral Anti-Diabetic Drug (TZD) on Progression of Diabetic Nephropathy on
Study Start Date : March 2008
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pioglitazone add on to SU or biguanide 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.
Active Comparator: 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.



Primary Outcome Measures :
  1. Onset and progression of diabetic nephropathy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846716


Contacts
Contact: Hiroshi Maegawa, PhD +81-77-548-2222 maegawa@belle.shiga-med.ac.jp
Contact: Takashi Uzu, PhD +81-77-548-2222 tuzu@belle.shiga-med.ac.jp

Locations
Japan
Shiga University of Medical Science Recruiting
Otsu, Shiga, Japan, 520-2192
Contact: Hiroshi Maegawa, PhD    +81-77-548-2222    maegawa@belle.shiga-med.ac.jp   
Contact: Takashi Uzu, PhD    +81-77-548-2222    tuzu@belle.shiga-med.ac.jp   
Principal Investigator: Yoshihiko Nishio, PhD         
Principal Investigator: Takashi Uzu, PhD         
Principal Investigator: Masato Ohji, PhD         
Sub-Investigator: Osamu Sawada, PhD         
Principal Investigator: Daisuke Koya, PhD         
Sponsors and Collaborators
Shiga University
Kanazawa Medical University
Nagahama Red Cross Hospital
Nagahama City Hospital
Kohka Public Hospital
Second Okamoto General Hospital
Omihachiman COmmunity Medical Center
Yasu Hospital
Toyosato Hospital
Ako City Hospital
Horide Clinic
Kawabata Clinic
Seta Clinic
Shiga Clinic
Osaka University
NTT West Osaka Hospital
Hyogo prefectural Amagasaki Hospital
Tomita Clinic
Sawada Clinic
Social Insurance Shiga Hospital
Investigators
Study Chair: Atsunori Kashiwagi, PhD. Tsukiwa-machi, Seta, Otsu, Shiga, Japan

Responsible Party: Atsunori Kashiwagi, Shiga University of Medical Science
ClinicalTrials.gov Identifier: NCT00846716     History of Changes
Other Study ID Numbers: 2008.9.18 ver2-4
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009

Keywords provided by Shiga University:
Type 2 Diabetes Mellitus
Diabetic Nephropathy
Diabetic Retinopathy
pioglitazone

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Pioglitazone
Biguanides
Hypoglycemic Agents
Physiological Effects of Drugs