Clinical trial NCT02786979: Efficacy and Safety of Dorner Tablets and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients
Official title: Combination of Beraprost Sodium Tablets (Dorner) and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Arteriosclerosis
beraprost
Aspirin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-06-01
Enrollment: 190
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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;

Primary outcomes:
measure: Change from baseline in carotid intima-media thickness
timeFrame: Baseline to Year 3
measure: Incidence and severity of treatment-emergent adverse events
timeFrame: Up to 3 years
measure: Safety assessed by vital signs: body temperature
timeFrame: Up to 3 years
measure: Safety assessed by vital signs: pulse rate
timeFrame: Up to 3 years
measure: Safety assessed by vital signs: respiratory rate
timeFrame: Up to 3 years
measure: Safety assessed by vital signs: blood pressure (systolic blood pressure and diastolic blood pressure)
timeFrame: Up to 3 years
measure: Number of participants with abnormal laboratory values and/or adverse events related to treatment
timeFrame: Up to 3 years
Secondary outcomes:
measure: Death rate
timeFrame: Up to 3 years
measure: Incidence of any vascular event
timeFrame: Baseline to Year 3
measure: Change from baseline in Ankle-brachial index
timeFrame: Baseline to Year 3
measure: Change from baseline in Pulse wave velocity
timeFrame: Baseline to Year 3
measure: Change from baseline in Oxidative stress indices
timeFrame: Baseline to Year 3
measure: Change from baseline in value of VCAM-1
timeFrame: Baseline to Year 3
measure: Change from baseline in value of TNF-α
timeFrame: Baseline to Year 3
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site CN00001
state: Beijing
city: Beijing
country: China
facility: Site CN00002
state: Beijing
city: Guangzhou
country: China
facility: Site CN00004
state: Guangdong
city: Shanghai
country: China
facility: Site CN00003
state: Shanghai
city: Chengdu
country: China
facility: Site CN00005
state: Sichuan
city: Tianjin
country: China
facility: Site CN00006
state: Tianjin
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: