Skip to main content
OpenTrials
Completed

NCT Number: NCT01869881

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University, Anam

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anplag(Sarpogrelate)

Drug

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

Placebo

Drug

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

Primary outcomes

  1. ACR(Urine Albumin/Creatinine ratio)

    Time frame: treatment period(24 weeks)

    change of percentage

Secondary outcomes

  1. ACR(Urine Albumin/Creatinine ratio)

    Time frame: 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)

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

    Time frame: treatment period(24 weeks)

    changes comparing to baseline data

  3. ACR(Urine Albumin/Creatinine ratio)

    Time frame: treatment period(24 weeks)

    improved amount comparing to baseline data

  4. ACR(Urine Albumin/Creatinine ratio)

    Time frame: treatment period(24 weeks)

    rate of normalized ACR

  5. Creatinine

    Time frame: treatment period(24 weeks)

    improved amount of Creatinine

  6. PCR(Protein to Creatinine ratio in Urine)

    Time frame: treatment period(24 weeks)

    improved rate comparing to baseline data

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 5, 2013
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.