Shiga Progression of Diabetes, Nephropathy and Retinopathy

Shiga University400 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Type 2 Diabetes Mellitus

Interventions

Pioglitazone add on to SU or biguanideDRUG

As an initial dosing, 15mg/day of pioglitazone is administered to the patients for 2 years, who are taking SU or biguanide.

SU or BiguanideDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Shiga University of Medical Science

Ōtsu, Shiga, Japan

RECRUITING

Outcomes

Primary Outcomes

Onset and progression of diabetic nephropathy

Time frame: 2 years

Secondary Outcomes

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

Central Contacts

Hiroshi Maegawa, PhD

CONTACT

+81-77-548-2222 maegawa@belle.shiga-med.ac.jp

Takashi Uzu, PhD

CONTACT

+81-77-548-2222 tuzu@belle.shiga-med.ac.jp

Data from ClinicalTrials.gov

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