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

February 18, 2009 updated by: Shiga University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
        • Recruiting
        • Shiga University of Medical Science
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Onset and progression of diabetic nephropathy
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiga University

Collaborators

Osaka 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
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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

December 11, 2008

First Submitted That Met QC Criteria

February 18, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

February 19, 2009

Last Update Submitted That Met QC Criteria

February 18, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.9.18 ver2-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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