Shiga Progression of Diabetes, Nephropathy and Retinopathy

Type 2 Diabetes Mellitus Clinical Trial

— SHIP-DINER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00846716
• Other study ID #: 2008.9.18 ver2-4
• Status: Recruiting
• Phase: N/A
• First received: December 11, 2008
• Last updated: February 18, 2009
• Start date: March 2008
• Est. completion date: November 2011

Study information

• Verified date: February 2009
• Source: Shiga University
• Contact: Hiroshi Maegawa, PhD
• Phone: +81-77-548-2222
• Email: maegawa[@]belle.shiga-med.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Kidney Diseases
• Type 2 Diabetes Mellitus

Intervention

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.
• SU or Biguanide
As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.

Locations

Country	Name	City	State
Japan	Shiga University of Medical Science	Otsu	Shiga

Sponsors (20)

Lead Sponsor

Collaborator

Shiga University

Ako City Hospital, Horide Clinic, Hyogo prefectural Amagasaki Hospital, Kanazawa Medical University, Kawabata Clinic, Kohka Public Hospital, Nagahama City Hospital, Nagahama Red Cross Hospital, NTT West Osaka Hospital, Omihachiman COmmunity Medical Center, Osaka University, Sawada Clinic, Second Okamoto General Hospital, Seta Clinic, Shiga Clinic, Social Insurance Shiga Hospital, Tomita Clinic, Toyosato Hospital, Yasu Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset and progression of diabetic nephropathy		2 years	No
Secondary	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	No