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

• Sponsor: Yuhan Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01869881
• Collaborator: (none)
• Enrollment: 151
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.9
• Patients Per Site Per Month: 6.3

Study Details

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
• Actual Enrollment: 151 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
• Actual Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Nov 17, 2014
• Actual Study Completion Date: Jan 28, 2015

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. ACR(Urine Albumin/Creatinine ratio) [treatment period(24 weeks)]

   change of percentage

Secondary Outcome Measures

1. 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)

2. urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen [treatment period(24 weeks)]

   changes comparing to baseline data

3. ACR(Urine Albumin/Creatinine ratio) [treatment period(24 weeks)]

   improved amount comparing to baseline data

4. ACR(Urine Albumin/Creatinine ratio) [treatment period(24 weeks)]

   rate of normalized ACR

5. Creatinine [treatment period(24 weeks)]

   improved amount of Creatinine

6. PCR(Protein to Creatinine ratio in Urine) [treatment period(24 weeks)]

   improved rate comparing to baseline data

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Korea University, Anam	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yuhan Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuhan Corporation
• ClinicalTrials.gov Identifier: NCT01869881
• Other Study ID Numbers: YCM009
• First Posted: Jun 5, 2013
• Last Update Posted: Apr 23, 2021
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Kidney Diseases; Diabetic Nephropathies; Sarpogrelate

Study Results

No Results Posted as of Apr 23, 2021