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The Effect of Prostaglandin I2 on the Endothelial Cell Function Disorder in Type 2 Diabetes Mellitus Patients

This study has been completed.
Sponsor:
Collaborators:
Severance Hospital
Yonsei University
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01061060
First received: February 1, 2010
Last updated: November 2, 2010
Last verified: November 2010
History of Changes
  Purpose

This study attempts to examine the effect of oral prostaglandin I2 (Beraprost Na), administered for eight weeks, on the endothelial cell functional disorder among asymptomatic high risk diabetes mellitus patients.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Peripheral Microvascular Symptoms
 Drug: Prostaglandin I2
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Prostaglandin I2 (Beraprost Na), Administered Orally for Eight Weeks, on the Endothelial Cell Functional Disorder in Type II Diabetes Mellitus Patients With Symptoms of a Minute Peripheral Blood Flow Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Symptomatic improvement by Total Symptom Score (TSS) [ Time Frame: after 8-week treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise [ Time Frame: after 8-week treatment ] [ Designated as safety issue: No ]
  • Change in mean rate of blood flow in the toes [ Time Frame: after 8-week treatment ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Beraprost group
Prostaglandin I2
 Drug: Prostaglandin I2
oral
Other Name: Beraprost Na
Placebo Comparator: Placebo group Drug: Placebo
oral

Detailed Description:

This study plans to include those subjects who have complaint of peripheral microvascular symptoms but have evidences of having neither a coronary arterial disease nor a peripheral arterial disease and show normal findings in the vascular stiffness test (PWV and ABI)) and plethysmography of the legs (PVR)) ,among Type II diabetes mellitus patients of forty-five (45) years old or older, This study is conducted by using a randomized double blind method. These drugs are distributed through a pharmacy in the clinical study center and administered randomly for eight weeks while this study allots patients by using a double blind method. Beraprost Na is administered along with a placebo that was manufactured by the same manufacturer to have the identical exterior look and weight of Beraprost Na. After eight weeks of drug administration, this investigation attempts to verify symptomatic improvement and change in the endothelial function by using VENDYS® and ICG perfusion imaging.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type II diabetes mellitus patient
  • Patients with symptoms of a minute peripheral blood flow disorder

Exclusion Criteria:

  • Cases with either an already-diagnosed coronary arterial disease or a peripheral vascular disease
  • Cases with a history of stroke
  • Cases with an abnormal finding of vascular stiffness test (PWV and ABI) and plethysmography of legs (PVR)
  • Pregnant women or fertile women with an unclear pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061060

Locations
Korea, Republic of
Seoul, Seodaemun-gu, Korea, Republic of, 120-752
Sponsors and Collaborators
Astellas Pharma Inc
Severance Hospital
Yonsei University
Investigators
Principal Investigator: Professor Dong-Hoon Choi Department of Internal Medicine, Severance Hospital, Yonsei Medical School, Yonsei University
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01061060     History of Changes
Other Study ID Numbers: BER-CL-AKR-2009-01
Study First Received: February 1, 2010
Last Updated: November 2, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Prostaglandin I2
Beraprost Na
Endothelial cell function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Beraprost
Epoprostenol
Tezosentan
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on June 13, 2013