Diabetic nephropathy
Conditions
Interventions
Type 2 diabetic patients with HbA1c more than 6.9% and less than 10.0% (NSGP value) having been under a diet/exercise treatment or under treatment of a same hypoglycemic agent for at least three month
s condition, 50 mg may be administered only once a day in the morning. Observation period for 4 weeks, and drug administration period for 24 weeks, totaling 28 weeks of duration.
Sponsors
Faculty of Medicine, Kagawa University
Shionoe Branch of Takamatsu Municipal Hospital Takamatsu Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 Diabetic nephropathy patients who do not show sufficient therapeutic effects by any of the following treatments. They should meet all the standards shown below. 1) HbA1c is more than 6.9% and less than 10.0% (NSGP value) 2) Under a diet/exercise treatment or medical treatment for at least three months or more. The kind of the oral hypoglycemic agent used is not asked. The patient should be administered with a same Sulfonylurea, if any, at the dosage less than the daily dose shown below for three months or more. # 2.5 mg/day for Glibenclamide # 60 mg/day for Gliclazide # 3 mg/day for Glimepiride 3) eGFR is more than 50 ml/min.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1c (NGSP) value at 12 weeks after administration. Changes in eGFR and urinary albumin level at 12 weeks after administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 . | — |
Countries
Japan
Contacts
Public ContactYoko Nishijima
Faculty of Medicine, Kagawa University Cardiorenal and Cerebrovascular Medicine
Outcome results
None listed