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

Phase 4

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Beraprost; Drug: Aspirin

• Registration Number: NCT02786979
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-01
• Last Update Submitted: 2016-06-17
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beraprost sodium tablet and Aspirin combination group	Beraprost	Oral
Beraprost sodium tablet and Aspirin combination group	Aspirin	Oral
Aspirin Group	Aspirin	Oral

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Site CN00006; 🇨🇳 Tianjin, Tianjin, China

Site CN00001; 🇨🇳 Beijing, Beijing, China

Site CN00003; 🇨🇳 Shanghai, Shanghai, China

Site CN00005; 🇨🇳 Chengdu, Sichuan, China

Site CN00002; 🇨🇳 Beijing, Beijing, China

Site CN00004; 🇨🇳 Guangzhou, Guangdong, China