Efficacy and Safety of Dorner Tablets and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients

Study Overview
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Brief Summary
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The objective was to evaluate the efficacy and safety of combination of beraprost and aspirin for prevention of arteriosclerosis progress in type 2 diabetes mellitus patients.

Official Title
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Combination of Beraprost Sodium Tablets (Dorner) and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Beraprost
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as type 2 diabetes mellitus; Patients who had the intima-media thickness (IMT) of carotid artery ≥1.1 mm in at least one side; Patients who had results of aspartate aminotransferase, alanine aminotransferase, and serum creatinine no more than 1.5 times higher than the upper limit of normal; Patients who had not cardio or cerebral vascular events within 3 months, including non-fatal myocardial infarction, stable and unstable angina pectoris, and non-fatal cerebral ischemic and hemorrhagic stroke; Patients who had their systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg, and glycated hemoglobin (HbA1c) <8.0%; Patients who had not taken any medications with antithrombotic and antiplatelet effect within 3 months; Exclusion Criteria: Patients who had peptic ulcer or active alimentary tract hemorrhage; Patients who had a known allergy to prostacycline or non-steroid medications; Patients who were pregnant, breast feeding, or had planned to be pregnant; Patients who were attending or had attended any clinical studies within 3 months;

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beraprost sodium tablet and Aspirin combination group<br>Oral | Drug: Beraprost<br>* Oral<br>* Other names: Dorner (R);Drug: Aspirin<br>* Oral<br>|
| Experimental: Aspirin Group<br>Oral | Drug: Aspirin<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in carotid intima-media thickness |  | Baseline to Year 3 | 
| Incidence and severity of treatment-emergent adverse events |  | Up to 3 years | 
| Safety assessed by vital signs: body temperature |  | Up to 3 years | 
| Safety assessed by vital signs: pulse rate |  | Up to 3 years | 
| Safety assessed by vital signs: respiratory rate |  | Up to 3 years | 
| Safety assessed by vital signs: blood pressure (systolic blood pressure and diastolic blood pressure) |  | Up to 3 years | 
| Number of participants with abnormal laboratory values and/or adverse events related to treatment |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death rate |  | Up to 3 years | 
| Incidence of any vascular event | Vascular events include sudden death, death caused by the vascular event, non-fatal coronary hear disease (CHD), non-fatal cerebrovascular diseases, and non-fatal aorta and peripheral artery disease (PAD) | Baseline to Year 3 | 
| Change from baseline in Ankle-brachial index |  | Baseline to Year 3 | 
| Change from baseline in Pulse wave velocity |  | Baseline to Year 3 | 
| Change from baseline in Oxidative stress indices | Oxidative stress indices: superoxide dismutase and nitrotyrosine | Baseline to Year 3 | 
| Change from baseline in value of VCAM-1 | VCMA-1: vascular cell adhesion molecule | Baseline to Year 3 | 
| Change from baseline in value of TNF-α | TNF: tumor necrosis factor | Baseline to Year 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Arteriosclerosis, beraprost, Aspirin