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

Condition(s) targeted: Type 2 Diabetes Mellitus; Peripheral Microvascular Symptoms

Intervention: Prostaglandin I2 (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Professor Dong-Hoon Choi, Principal Investigator, Affiliation: Department of Internal Medicine, Severance Hospital, Yonsei Medical School, Yonsei University

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Symptomatic improvement by Total Symptom Score (TSS)

Secondary outcome:

Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise

Change in mean rate of blood flow in the toes

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.

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

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

Seoul, Seodaemun-gu 120-752, Korea, Republic of

Starting date: January 2010
Last updated: November 2, 2010