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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01869881
Recruitment Status : Unknown
Verified July 2014 by Yuhan Corporation.
Recruitment status was:  Active, not recruiting
First Posted : June 5, 2013
Last Update Posted : July 10, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: Anplag(Sarpogrelate) Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes
Study Start Date : February 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Sarpogrelate Drug: Anplag(Sarpogrelate)
Sarpogrelate 100mg 2 tablets, bid, 400mg/day
Placebo Comparator: Placebo Drug: Placebo
Placebo 100mg 2 tablets, bid, 400mg/day

Outcome Measures

Primary Outcome Measures :
  1. Safety [ Time Frame: treatment period(24 weeks) ]
    adverse event and rate of adverse event

  2. ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ]
    change of percentage

Secondary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869881

Korea, Republic of
Korea University, Anam
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Principal Investigator: D.S Choi, MD, PhD Korea University Hospital, Anam
More Information

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01869881     History of Changes
Other Study ID Numbers: YCM009
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs