Type 2 Diabetes MellitusPhase 4NCT01061060
The Effect of Prostaglandin I2 on the Endothelial Cell Function Disorder in Type 2 Diabetes Mellitus Patients
A Phase 4 study testing Prostaglandin I2 in people with Type 2 Diabetes Mellitus and Peripheral Microvascular Symptoms, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Peripheral Microvascular Symptoms
- What is being tested?
- Prostaglandin I2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Oct 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type II diabetes mellitus patient
- Patients with symptoms of a minute peripheral blood flow disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Prostaglandin I2, Placebo
- Keywords
- Prostaglandin I2, Beraprost Na, Endothelial cell function
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostaglandin I2Drug
Also called Beraprost Na
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Beraprost group | Experimental | Prostaglandin I2 Receives: Drug: Prostaglandin I2 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic improvement by Total Symptom Score (TSS)
Measured: after 8-week treatment
Secondary outcomes (2)
Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise
Measured: after 8-week treatment
Change in mean rate of blood flow in the toes
Measured: after 8-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Responsible party
- Principal investigator, Donghoon Choi, Yonsei University
- Investigators
- Professor Dong-Hoon Choi, Principal investigator, Department of Internal Medicine, Severance Hospital, Yonsei Medical School, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061060
- Sponsor's protocol ID
- BER-CL-AKR-2009-01
- Status last verified
- Feb 2016
- First submitted
- 1 Feb 2010
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01061060
- Acronym / sponsor ID
- BER-CL-AKR-2009-01
- Keywords
- Prostaglandin I2, Beraprost Na, Endothelial cell function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beraprost group | Experimental | Drug: Prostaglandin I2Prostaglandin I2 |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type II diabetes mellitus patient
- Patients with symptoms of a minute peripheral blood flow disorder
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostaglandin I2Also: Beraprost Naoral | Drug | Beraprost group |
| Placebooral | Drug | Placebo group |
Primary outcome
Symptomatic improvement by Total Symptom Score (TSS)
Time frame: after 8-week treatment
2 secondary outcomes
Change in endothelial function expressed in the unit of temperature rebound and the extent of its rise
Time frame: after 8-week treatment
Change in mean rate of blood flow in the toes
Time frame: after 8-week treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Dong-Hoon Choi principal investigator
Department of Internal Medicine, Severance Hospital, Yonsei Medical School, Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prostaglandin I2 in people with Type 2 Diabetes Mellitus and Peripheral Microvascular Symptoms, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic improvement by Total Symptom Score (TSS) (time frame: after 8-week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.