Diabetic Nephropathy
Conditions
Brief summary
Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.
Interventions
DRUGAnplag(Sarpogrelate)
Sarpogrelate 100mg 2 tablets, bid, 400mg/day
DRUGPlacebo
Placebo 100mg 2 tablets, bid, 400mg/day
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* person who signed on ICF * Type 2 diabetic patient who have microalbuminuria or overt proteinuria * In case of hypertension patients, who keep the same medication steadily over last 4 weeks
Exclusion criteria
* patients who have hypersensitivity on sarpogrelate or other salicylic acid * patients who should keep the antiplatelet agent because of acute cardiac disease or peripheral vein disease * patients who took other anticoagulant agent within 1 month * patient who take ACEI OR ARB but not controlled(over 150/100mmHg) * Type 1 diabetes patients * Patient who have cardiac or liver problem * Cr: \>1.8mg/dl or GFR: \<40ml/min * malignant tumor patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR(Urine Albumin/Creatinine ratio) | treatment period(24 weeks) | change of percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACR(Urine Albumin/Creatinine ratio) | Treatment period(24 weeks) | improvement efficiency rate of ACR comparing to baseline Definition of improvement efficiency : ACR become normal(\<20mg/g Cr) or ACR is decreased more than 50% comparing to data before taking IP(Investigators' product) |
| urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen | treatment period(24 weeks) | changes comparing to baseline data |
| Creatinine | treatment period(24 weeks) | improved amount of Creatinine |
| PCR(Protein to Creatinine ratio in Urine) | treatment period(24 weeks) | improved rate comparing to baseline data |
Countries
South Korea
Outcome results
None listed