UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011137 |
|---|---|
| Receipt number | R000013043 |
| Scientific Title | The effect of beraprost sodium on the surrogate markers of atherosclerosis in type 2 diabetes mellitus |
| Date of disclosure of the study information | 2013/07/06 |
| Last modified on | 2020/01/10 11:29:11 |
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Basic information
Public title
The effect of beraprost sodium on the surrogate markers of atherosclerosis in type 2 diabetes mellitus
Acronym
The effect of beraprost sodium on the surrogate markers of atherosclerosis in type 2 diabetes mellitus
Scientific Title
The effect of beraprost sodium on the surrogate markers of atherosclerosis in type 2 diabetes mellitus
Scientific Title:Acronym
The effect of beraprost sodium on the surrogate markers of atherosclerosis in type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of beraprost sodium on the surrogate markers of atherosclerosis and the glucose metabolism related markers, and its safety in type 2 diabetes mellitus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Atherosclerosis, glucose metabolism, diabetic nephropathy, QOL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Duration 6 months
Subject type 2 diabetes mellitus
Drug therapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who has stable glycemic control (HbA1c less than 8.4% (NGSP))
Patient who has stable blood pressure control
Patient whose ABI is between 0.9 and 1.0 and who is diagnosed as ASO clinically
Key exclusion criteria
Patient whom beraprost sodium is contraindicated for
Patient who takes vasodilator (nitrates)
Patinet who has been started anitiplatelet drugs and/or drugs for dyslipidemia within 3 months before starting beraprost sodium
Patinet who have been changed drugs for diabetes mellitus within 3 months before starting beraprost sodium
Patient whose ABI is less than 0.9
Patinet who take glucocorticoids and NSAID (except aspirin)
Patient who has the impairment of renal function (Cr more than 2 mg/dl)
Patient who is unsuitable for this study (judged by a doctor)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Otsuki |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
565-0871
Address
2-2 Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3732
otsuki@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Otsuki |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
565-0871
Address
2-2 Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3732
Homepage URL
otsuki@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Metabolic Medicine
Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-15 Yamada-oka, Suita, Osaka, Japan
Tel
06-6879-5682
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
25
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013043
