Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Arteriosclerosis, beraprost, Aspirin
Brief 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.
Interventions
DRUGBeraprost
Oral
DRUGAspirin
Oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with abnormal laboratory values and/or adverse events related to treatment | Up to 3 years |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death rate | Up to 3 years | — |
| Incidence of any vascular event | Baseline to Year 3 | 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) |
| 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 | Baseline to Year 3 | Oxidative stress indices: superoxide dismutase and nitrotyrosine |
| Change from baseline in value of VCAM-1 | Baseline to Year 3 | VCMA-1: vascular cell adhesion molecule |
| Change from baseline in value of TNF-α | Baseline to Year 3 | TNF: tumor necrosis factor |
Countries
China
Outcome results
None listed