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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02786979
• Other study ID #: DorDM002
• Status: Terminated
• Phase: Phase 4
• First received: May 26, 2016
• Last updated: June 17, 2016
• Start date: July 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 190
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Beraprost
Oral
• Aspirin
Oral

Locations

Country	Name	City	State
China	Site CN00001	Beijing	Beijing
China	Site CN00002	Beijing	Beijing
China	Site CN00005	Chengdu	Sichuan
China	Site CN00004	Guangzhou	Guangdong
China	Site CN00003	Shanghai	Shanghai
China	Site CN00006	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in carotid intima-media thickness		Baseline to Year 3	No
Primary	Incidence and severity of treatment-emergent adverse events		Up to 3 years	No
Primary	Safety assessed by vital signs: body temperature		Up to 3 years	No
Primary	Safety assessed by vital signs: pulse rate		Up to 3 years	No
Primary	Safety assessed by vital signs: respiratory rate		Up to 3 years	No
Primary	Safety assessed by vital signs: blood pressure (systolic blood pressure and diastolic blood pressure)		Up to 3 years	No
Primary	Number of participants with abnormal laboratory values and/or adverse events related to treatment		Up to 3 years	No
Secondary	Death rate		Up to 3 years	No
Secondary	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	No
Secondary	Change from baseline in Ankle-brachial index		Baseline to Year 3	No
Secondary	Change from baseline in Pulse wave velocity		Baseline to Year 3	No
Secondary	Change from baseline in Oxidative stress indices	Oxidative stress indices: superoxide dismutase and nitrotyrosine	Baseline to Year 3	No
Secondary	Change from baseline in value of VCAM-1	VCMA-1: vascular cell adhesion molecule	Baseline to Year 3	No
Secondary	Change from baseline in value of TNF-a	TNF: tumor necrosis factor	Baseline to Year 3	No