Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes (SONATA Study)

Yuhan Corporation151 enrolled

Overview

Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

151

Conditions

Diabetic Nephropathy

Interventions

Anplag(Sarpogrelate)DRUG

Sarpogrelate 100mg 2 tablets, bid, 400mg/day

PlaceboDRUG

Placebo 100mg 2 tablets, bid, 400mg/day

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Korea University, Anam

Seoul, South Korea

Outcomes

Primary Outcomes

ACR(Urine Albumin/Creatinine ratio)

change of percentage

Time frame: treatment period(24 weeks)

Secondary Outcomes

ACR(Urine Albumin/Creatinine ratio)

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)

Time frame: Treatment period(24 weeks)

urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen

changes comparing to baseline data

Time frame: treatment period(24 weeks)

ACR(Urine Albumin/Creatinine ratio)

improved amount comparing to baseline data

Time frame: treatment period(24 weeks)

ACR(Urine Albumin/Creatinine ratio)

rate of normalized ACR

Time frame: treatment period(24 weeks)

Creatinine

improved amount of Creatinine

Time frame: treatment period(24 weeks)

PCR(Protein to Creatinine ratio in Urine)

improved rate comparing to baseline data

Time frame: treatment period(24 weeks)

Data from ClinicalTrials.gov

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