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

Astellas

Status and phase: Terminated; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Aspirin; Drug: Beraprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT02786979

DorDM002

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Beraprost sodium tablet and Aspirin combination group

Experimental group

Description:

Oral

Treatment:

Drug: Beraprost

Drug: Aspirin

Aspirin Group

Experimental group

Description:

Oral

Treatment:

Drug: Aspirin