A Study to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilostazol/Ginkgo Leaf Extract and Aspirin in Diabetic Peripheral Angiopathy.

Study Overview
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Brief Summary
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This study is to compare and evaluate the effect of improving the carotid IMT and lipid level of the Cilostazol/Ginkgo leaf extract group with the aspirin administrated group in patients with diabetic peripheral angiopathy.

Official Title
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A Prospective, Randomized, Active-controlled, Parallel, Open, Multi-center, Phase IV, Exploratory Clinical Trial to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilostazol/Ginkgo Leaf Extract (Renexin CR) and Aspirin (Aspirin Protect Tab.) in Diabetic Peripheral Angiopathy.

Conditions
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Diabetic Peripheral Angiopathy

Intervention / Treatment
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* Drug: Renexin CR 200/160mg
* Drug: Aspirin 100mg


Participation Criteria
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Eligibility Criteria
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<Inclusion Criteria> Male or female aged between 20 years and 75 years(inclusive) Patients who diagnosed as type 2 diabetes and diabetic peripheral angiopathy Patients with a maximum intra-carotid membrane thickness (maximum IMT) of 0.9 mm or more among the thickest areas, including plaques, in the CCA, ICA, and Bulb three areas of the carotid artery <Exclusion Criteria> Patients who diagnosed with type 1 diabetes, secondary diabetes, or gestational diabetes Patients with cerebrovascular or cardiovascular complications within 6 months of screening (cerebral infarction, transient ischemic seizures, myocardial infarction, unstable angina, coronary artery bypass graft(CABG), PCI, etc.) Patients with bleeding (hemophilia, capillary weakness, intracranial hemorrhage, upper digestive tract hemorrhage, urinary tract hemorrhage, hematopoietic hemorrhage, active digestive ulcers, etc.) or peptic ulcers within 3 months of screening Patient who took anticoagulants, antiplatelet drugs including aspirin, cilostazol, thrombolytic agents, prostaglandin E1 and glucagon-like peptide -1 (GLP-1) receptor agonist within 2 weeks of the baseline

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renexin CR 200/160mg<br>Single oral administration of Renexin CR 200/160mg, QD | Drug: Renexin CR 200/160mg<br>* Single oral administration of Renexin CR 200/160mg, QD<br>* Other names: Renexin CR;|
| Active Comparator: Aspirin 100mg<br>Single oral administration of Aspirin 100mg, QD | Drug: Aspirin 100mg<br>* Single oral administration of Aspirin 100mg, QD<br>* Other names: Aspirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in carotid IMT | Changes in carotid IMT after 24weeks, 48weeks of administration compared to before administration of investigational product | 24weeks, 48weeks |