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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients

NCT00427271

Diabetes Mellitus Microalbuminuria

UNKNOWN PHASE4

Aspirin Twice a Day in Patients With Diabetes and Acute Coronary Syndrome

NCT02520921

Diabetes Mellitus Acute Coronary Syndrome Coronary Artery Disease +1 more

COMPLETED PHASE4

Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome

NCT00272311

Cardiovascular Diseases Metabolic Syndrome X Atherosclerosis

COMPLETED PHASE4

Modified-release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-resistant Patients

NCT00129038

Coronary Arteriosclerosis

COMPLETED PHASE4

A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy Participants

NCT05093790

Coronary Artery Disease Healthy Participants

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Beraprost sodium tablet and Aspirin combination group

Oral

Group Type EXPERIMENTAL

Beraprost

Intervention Type DRUG

Oral

Aspirin

Intervention Type DRUG

Oral

Aspirin Group

Oral

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Beraprost

Oral

Intervention Type DRUG

Aspirin

Oral

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dorner (R)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No