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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003089
Receipt No. R000002254
Scientific Title Effects of beraprost sodium on improvement of insulin resistance in patients with type 2 diabetes and peripheral arterial disease
Date of disclosure of the study information 2010/01/25
Last modified on 2014/04/24

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Basic information
Public title Effects of beraprost sodium on improvement of insulin resistance in patients with type 2 diabetes and peripheral arterial disease
Acronym Effects of beraprost sodium on improvement of insulin resistance in patients with type 2 diabetes and peripheral arterial disease
Scientific Title Effects of beraprost sodium on improvement of insulin resistance in patients with type 2 diabetes and peripheral arterial disease
Scientific Title:Acronym Effects of beraprost sodium on improvement of insulin resistance in patients with type 2 diabetes and peripheral arterial disease
Region
Japan

Condition
Condition Patients with type 2 diabetes and peripheral arterial disease
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of beraprost sodium on improvement of insulin resistance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glucose infusion rate on euglycemic hyperinsulinemic clamp (0, 12 weeks)
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 Oral beraprost sodium for 12 weeks for patients with type 2 diabetes and peripheral arterial disease
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
80 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetes
HbA1c<8%
BMI>=25 or "Male Waist>=85cm or Female Waist>=90cm"
with untreated peripheral arterial disease
Key exclusion criteria - Patients with bleeding tendancy
- Patients with severe renal dysfunction
- Patients with liver dysfunction
- Patients with a past hystory of drug hypersensitivity
- Pregnant women or women with breast-feeding
- Patients who took prostaglandin derivatives within 3 months
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Kubota
Organization Graduate School of Medicine, University of Tokyo
Division name Department of Metabolic Diseases
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-8818
Email nkubota-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisayuki Katsuyama
Organization Graduate School of Medicine, University of Tokyo
Division name Department of Metabolic Diseases
Zip code
Address Hongo 7-3-1, Bunkyo, Tokyo, Japan
TEL 03-5800-8818
Homepage URL
Email katsuyama-hs@umin.ac.jp

Sponsor
Institute Graduate School of Medicine, University of Tokyo
Department of Metabolic Diseases
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science & Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東京大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://link.springer.com/article/10.1007/s13340-014-0169-8
Number of participants that the trial has enrolled
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
2009 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 06 Month 08 Day
Date of closure to data entry
2012 Year 03 Month 31 Day
Date trial data considered complete
2012 Year 03 Month 31 Day
Date analysis concluded
2013 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 25 Day
Last modified on
2014 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002254

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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