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

Combination of Beraprost Sodium Tablets (Dorner) and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients

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.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Beraprost; Drug: Aspirin

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Site CN00001
    • Beijing, Beijing, China
      • Site CN00002
  • Guangdong
    • Guangzhou, Guangdong, China
      • Site CN00004
  • Shanghai
    • Shanghai, Shanghai, China
      • Site CN00003
  • Sichuan
    • Chengdu, Sichuan, China
      • Site CN00005
  • Tianjin
    • Tianjin, Tianjin, China
      • Site CN00006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beraprost sodium tablet and Aspirin combination group; Oral	Drug: Beraprost; Oral; Other Names: Dorner (R); Drug: Aspirin; Oral
Experimental: Aspirin Group; Oral	Drug: Aspirin; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Number of participants with abnormal laboratory values and/or adverse events related to treatment	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death rate		Up to 3 years
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)	Baseline to Year 3
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	Oxidative stress indices: superoxide dismutase and nitrotyrosine	Baseline to Year 3
Change from baseline in value of VCAM-1	VCMA-1: vascular cell adhesion molecule	Baseline to Year 3
Change from baseline in value of TNF-α	TNF: tumor necrosis factor	Baseline to Year 3

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Aspirin; Type 2 Diabetes Mellitus; Arteriosclerosis; beraprost
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Arteriosclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin; Beraprost
• Other Study ID Numbers: DorDM002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No