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

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Aspirin; Beraprost; Epoprostenol

Criteria

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;