Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Diabetic Nephropathy, Diabetic Retinopathy, pioglitazone
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: 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
Interventions
DRUGPioglitazone 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.
DRUGSU or Biguanide
As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.
Sponsors
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
Shiga University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Onset and progression of diabetic nephropathy | 2 years |
Secondary
| 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 | 2 years |
Countries
Japan
Contacts
Primary ContactHiroshi Maegawa, PhD
Backup ContactTakashi Uzu, PhD
Outcome results
None listed