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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02786979
Recruitment Status : Terminated (Upon interim analysis, sponsor's decision due to absence of demonstration of efficacy.)
First Posted : June 1, 2016
Last Update Posted : June 21, 2016
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Beraprost Drug: Aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Combination of Beraprost Sodium Tablets (Dorner) and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients
Study Start Date : July 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Beraprost sodium tablet and Aspirin combination group
Drug: Beraprost
Other Name: Dorner (R)

Drug: Aspirin

Experimental: Aspirin Group
Drug: Aspirin

Primary Outcome Measures :
  1. Change from baseline in carotid intima-media thickness [ Time Frame: Baseline to Year 3 ]
  2. Incidence and severity of treatment-emergent adverse events [ Time Frame: Up to 3 years ]
  3. Safety assessed by vital signs: body temperature [ Time Frame: Up to 3 years ]
  4. Safety assessed by vital signs: pulse rate [ Time Frame: Up to 3 years ]
  5. Safety assessed by vital signs: respiratory rate [ Time Frame: Up to 3 years ]
  6. Safety assessed by vital signs: blood pressure (systolic blood pressure and diastolic blood pressure) [ Time Frame: Up to 3 years ]
  7. Number of participants with abnormal laboratory values and/or adverse events related to treatment [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Death rate [ Time Frame: Up to 3 years ]
  2. Incidence of any vascular event [ Time Frame: 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)

  3. Change from baseline in Ankle-brachial index [ Time Frame: Baseline to Year 3 ]
  4. Change from baseline in Pulse wave velocity [ Time Frame: Baseline to Year 3 ]
  5. Change from baseline in Oxidative stress indices [ Time Frame: Baseline to Year 3 ]
    Oxidative stress indices: superoxide dismutase and nitrotyrosine

  6. Change from baseline in value of VCAM-1 [ Time Frame: Baseline to Year 3 ]
    VCMA-1: vascular cell adhesion molecule

  7. Change from baseline in value of TNF-α [ Time Frame: Baseline to Year 3 ]
    TNF: tumor necrosis factor

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02786979

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China, Beijing
Site CN00001
Beijing, Beijing, China
Site CN00002
Beijing, Beijing, China
China, Guangdong
Site CN00004
Guangzhou, Guangdong, China
China, Shanghai
Site CN00003
Shanghai, Shanghai, China
China, Sichuan
Site CN00005
Chengdu, Sichuan, China
China, Tianjin
Site CN00006
Tianjin, Tianjin, China
Sponsors and Collaborators
Astellas Pharma Inc
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Study Director: Medical Director Astellas Pharma Inc

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Responsible Party: Astellas Pharma Inc Identifier: NCT02786979    
Other Study ID Numbers: DorDM002
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc:
Type 2 Diabetes Mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Antihypertensive Agents