Back to resultsEfficacy and Safety of Dorner Tablets and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Beraprost
Aspirin
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Arteriosclerosis, beraprost, Aspirin
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;
Sites / Locations
- Site CN00001
- Site CN00002
- Site CN00004
- Site CN00003
- Site CN00005
- Site CN00006
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Beraprost sodium tablet and Aspirin combination group
Aspirin Group
Arm Description
Oral
Oral
Outcomes
Primary Outcome Measures
Change from baseline in carotid intima-media thickness
Incidence and severity of treatment-emergent adverse events
Safety assessed by vital signs: body temperature
Safety assessed by vital signs: pulse rate
Safety assessed by vital signs: respiratory rate
Safety assessed by vital signs: blood pressure (systolic blood pressure and diastolic blood pressure)
Number of participants with abnormal laboratory values and/or adverse events related to treatment
Secondary Outcome Measures
Death rate
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)
Change from baseline in Ankle-brachial index
Change from baseline in Pulse wave velocity
Change from baseline in Oxidative stress indices
Oxidative stress indices: superoxide dismutase and nitrotyrosine
Change from baseline in value of VCAM-1
VCMA-1: vascular cell adhesion molecule
Change from baseline in value of TNF-α
TNF: tumor necrosis factor
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02786979
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Upon interim analysis, sponsor's decision due to absence of demonstration of efficacy.
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, Arteriosclerosis, beraprost, Aspirin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beraprost sodium tablet and Aspirin combination group
Arm Type
Experimental
Arm Description
Oral
Arm Title
Aspirin Group
Arm Type
Experimental
Arm Description
Oral
Intervention Type
Drug
Intervention Name(s)
Beraprost
Other Intervention Name(s)
Dorner (R)
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Change from baseline in carotid intima-media thickness
Time Frame
Baseline to Year 3
Title
Incidence and severity of treatment-emergent adverse events
Time Frame
Up to 3 years
Title
Safety assessed by vital signs: body temperature
Time Frame
Up to 3 years
Title
Safety assessed by vital signs: pulse rate
Time Frame
Up to 3 years
Title
Safety assessed by vital signs: respiratory rate
Time Frame
Up to 3 years
Title
Safety assessed by vital signs: blood pressure (systolic blood pressure and diastolic blood pressure)
Time Frame
Up to 3 years
Title
Number of participants with abnormal laboratory values and/or adverse events related to treatment
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Death rate
Time Frame
Up to 3 years
Title
Incidence of any vascular event
Description
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)
Time Frame
Baseline to Year 3
Title
Change from baseline in Ankle-brachial index
Time Frame
Baseline to Year 3
Title
Change from baseline in Pulse wave velocity
Time Frame
Baseline to Year 3
Title
Change from baseline in Oxidative stress indices
Description
Oxidative stress indices: superoxide dismutase and nitrotyrosine
Time Frame
Baseline to Year 3
Title
Change from baseline in value of VCAM-1
Description
VCMA-1: vascular cell adhesion molecule
Time Frame
Baseline to Year 3
Title
Change from baseline in value of TNF-α
Description
TNF: tumor necrosis factor
Time Frame
Baseline to Year 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site CN00001
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Site CN00002
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Site CN00004
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Site CN00003
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Site CN00005
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Site CN00006
City
Tianjin
State/Province
Tianjin
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy and Safety of Dorner Tablets and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients
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