Multi-center cooperative clinical study on the renoprotective effect of DPP-4 inhibitor (Vildagliptin) in Diabetic nephropathy patients
Not Applicable
- Conditions
- Diabetic nephropathy
- Registration Number
- JPRN-UMIN000010261
- Lead Sponsor
- Faculty of Medicine, Kagawa University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with contraindications for Vildagliptin 2) Patients participating in other clinical trials 3) Women during pregnancy, after childbirth, on breastfeeding, or with the possibility of being pregnant. 4) Patients with other severe complications 5) Patients judged inadequate for other reasons by doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in HbA1c (NGSP) value at 12 weeks after administration. Changes in eGFR and urinary albumin level at 12 weeks after administration.
- Secondary Outcome Measures
Name Time Method (Only in patients who give consent) Changes in fasting or 1~2-hour-postprandial blood glucose concentration. Changes in urinary protein at 12 weeks after administration. Changes in the following biomarkers at 12 weeks after administration. (urinary 8-OHdG, plasma/urinary Angiotensinogen, urinary NGA, glycoalbumin only at eligible institutions) Changes in 24-hour blood pressure at 24 weeks after administration. Adverse events are to be investigated by doctors' oral consultation. Evaluation of the effectiveness and the safety of Vildagliptin .