An open label multi facilities cooperation randomized control trial to verify renoprotective effects of improvement in postprandial hyperglycemia in diabetic nephropathy.

An open label multi facilities cooperation randomized control trial to verify renoprotective effects of improvement in postprandial hyperglycemia in diabetic nephropathy. - Clinical trial to verify relation between postprandial hyperglycemia ameliorating effect by mitiglinide and renoprotective effect Mitiglinide can be expected to be more effective than glimepiride at reducing postprandial hyperglycemia and urinary albumin excretion. Mitiglinide reduces urinary albumin excretion by ameliorating postprandial hyperglycemia in diabetic nephropathy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003072

Enrollment

100

Registered

2010-04-01

Start date

2010-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetic nephropathy patients.

Interventions

This study is a prospective randomized control trial. The entry period of this study is two years. Subjects are type 2 diabetes with nephropathy. The Subjects are randomly assigned to two groups, miti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects enrolled in the present study are type 2 diabetes with nephropathy, who visit our hospital and fulfilled the following criteria: 1) HbA1c of 6.0-10.0 %, 2) urinary albumin/creatinine ratio (ACR) higher than 30 mg/g Cre, 3) Blood pressure less than 160/100 mmHg.

Exclusion criteria

Exclusion criteria: 1) Patient who has taken SU medicine within three months recent or been taking of SU medicine in present. 2) Patient for whom insulin treatment is necessary. 3) Patient who complicates severe and actively diabetic microangiopathy (retinopathy etc...). 4) Patient who complicates severe liver disease, kidney disease and heart disease. 5) Woman who has possibility of pregnancy or pregnancy and woman while suckling. 6) Patient who has already taken glinides. 7) It is a patient of the contraindication to administer the object medicine. 8) The doctor judged the patient's participation in the study to be improper.

Design outcomes

Primary

Measure	Time frame
Primary outcomes are the changes of postprandial plasma glucose levels, urinary albumin excretion and serum methylglyoxal levels, and urinary 8-OHdG, and MCP-1 excretions.	—

Secondary

Measure	Time frame
Secondary outcomes are the changes in plasma glucose, insulin and free fatty acid levels according to meal load.	—

Countries

Japan

Contacts

Public ContactSusumu Ogawa

Tohoku University Hospital Division of Nephrology, Endocrinology and Hypertension

ogawa-s@hosp.tohoku.ac.jp022-717-7166

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026