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

Shiga University

Status: Unknown

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: SU or Biguanide; Drug: Pioglitazone add on to SU or biguanide

Study type: Interventional

Funder types: Other

Identifiers

NCT00846716

2008.9.18 ver2-4

Details and patient eligibility

About

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.

Full description

2. Outcome measures:

3. Primary endpoint Onset or progression of diabetic nephropathy

4. 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

Enrollment: 400 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Pioglitazone add on to SU or biguanide

Experimental group

Treatment:

Drug: Pioglitazone add on to SU or biguanide

SU or Biguanide

Active Comparator group

Treatment:

Drug: SU or Biguanide