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

April 21, 2021 updated by: Yuhan Corporation

Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo 100mg 2 tablets, bid, 400mg/day
ACTIVE_COMPARATOR: Sarpogrelate
Drug: Anplag(Sarpogrelate)
Sarpogrelate 100mg 2 tablets, bid, 400mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACR(Urine Albumin/Creatinine ratio)
Time Frame: treatment period(24 weeks)
change of percentage
treatment period(24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Treatment period(24 weeks)
urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen
Time Frame: treatment period(24 weeks)
changes comparing to baseline data
treatment period(24 weeks)
ACR(Urine Albumin/Creatinine ratio)
Time Frame: treatment period(24 weeks)
improved amount comparing to baseline data
treatment period(24 weeks)
ACR(Urine Albumin/Creatinine ratio)
Time Frame: treatment period(24 weeks)
rate of normalized ACR
treatment period(24 weeks)
Creatinine
Time Frame: treatment period(24 weeks)
improved amount of Creatinine
treatment period(24 weeks)
PCR(Protein to Creatinine ratio in Urine)
Time Frame: treatment period(24 weeks)
improved rate comparing to baseline data
treatment period(24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: D.S Choi, MD, PhD, Korea University Hospital, Anam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2013

Primary Completion (ACTUAL)

November 17, 2014

Study Completion (ACTUAL)

January 28, 2015

Study Registration Dates

First Submitted

May 31, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (ESTIMATE)

June 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YCM009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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