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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Pioglitazone add on to SU or biguanide
SU or Biguanide
Sponsored by
Shiga University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Diabetic Nephropathy, Diabetic Retinopathy, pioglitazone

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shiga University of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pioglitazone add on to SU or biguanide

SU or Biguanide

Arm Description

Outcomes

Primary Outcome Measures

Onset and progression of diabetic nephropathy

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2008
Last Updated
February 18, 2009
Sponsor
Shiga University
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
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1. Study Identification

Unique Protocol Identification Number
NCT00846716
Brief Title
Shiga Progression of Diabetes, Nephropathy and Retinopathy
Acronym
SHIP-DINER
Official Title
Exploratory Study to Investigate the Suppressive Effect of Oral Anti-Diabetic Drug (TZD) on Progression of Diabetic Nephropathy on
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shiga University
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, Diabetic Nephropathy, Diabetic Retinopathy, pioglitazone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone add on to SU or biguanide
Arm Type
Experimental
Arm Title
SU or Biguanide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pioglitazone add on to SU or biguanide
Intervention Description
As an initial dosing, 15mg/day of pioglitazone is administered to the patients for 2 years, who are taking SU or biguanide.
Intervention Type
Drug
Intervention Name(s)
SU or Biguanide
Intervention Description
As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.
Primary Outcome Measure Information:
Title
Onset and progression of diabetic nephropathy
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hiroshi Maegawa, PhD
Phone
+81-77-548-2222
Email
maegawa@belle.shiga-med.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Takashi Uzu, PhD
Phone
+81-77-548-2222
Email
tuzu@belle.shiga-med.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atsunori Kashiwagi, PhD.
Organizational Affiliation
Tsukiwa-machi, Seta, Otsu, Shiga, Japan
Official's Role
Study Chair
Facility Information:
Facility Name
Shiga University of Medical Science
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Maegawa, PhD
Phone
+81-77-548-2222
Email
maegawa@belle.shiga-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Takashi Uzu, PhD
Phone
+81-77-548-2222
Email
tuzu@belle.shiga-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Yoshihiko Nishio, PhD
First Name & Middle Initial & Last Name & Degree
Takashi Uzu, PhD
First Name & Middle Initial & Last Name & Degree
Masato Ohji, PhD
First Name & Middle Initial & Last Name & Degree
Osamu Sawada, PhD
First Name & Middle Initial & Last Name & Degree
Daisuke Koya, PhD

12. IPD Sharing Statement

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Shiga Progression of Diabetes, Nephropathy and Retinopathy

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