UMIN-CTR Clinical Trial

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
Email	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
Email	otsuki@endmet.med.osaka-u.ac.jp

Sponsor
Institute	Department of Metabolic Medicine Osaka University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013043