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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005307
Receipt No. R000006311
Scientific Title Efficacy of ezetimibe on improvement of glucose metabolism in Japanese subjects with type 2 diabetes
Date of disclosure of the study information 2011/03/28
Last modified on 2011/09/26

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Basic information
Public title Efficacy of ezetimibe on improvement of glucose metabolism in Japanese subjects with type 2 diabetes
Acronym Efficacy of ezetimibe on improvement of glucose metabolism
Scientific Title Efficacy of ezetimibe on improvement of glucose metabolism in Japanese subjects with type 2 diabetes
Scientific Title:Acronym Efficacy of ezetimibe on improvement of glucose metabolism
Region
Japan

Condition
Condition type 2 diabetes with hypercholesterolemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigated the effect of ezetimibe on an improvement of glucose metabolism in subjects with type 2 diabetes, and further investigated factors predicting an improvement in glucose metabolism following ezetimibe administration
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Decrease of HbA1c
Key secondary outcomes Decrease of LDL-C

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 ezetiibe 10mg/day po
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type 2 diabetes with hypercholesterolemia
Key exclusion criteria Past alcohol intake of more than 20g/day
serological evidence of viral hepatitis
hemochromatosis
autoimmune liver disease
non-alcoholic steatohepatitis (NASH)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiya Shimoda
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
Address 1-1-1, Honjo, Kumamoto, 860-8556, Japan
TEL 097-373-5169
Email

Public contact
Name of contact person
1st name
Middle name
Last name Seiya Shimoda
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
Address 1-1-1, Honjo, Kumamoto, 860-8556, Japan
TEL 097-373-5169
Homepage URL
Email sshimoda@gpo.kumamoto-u.ac.jp

Sponsor
Institute Faculty of Life Sciences, Kumamoto University
Institute
Department

Funding Source
Organization Faculty of Life Sciences, Kumamoto University
Organization
Division
Category of Funding Organization Self funding
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 熊本大学病院(熊本市)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 28 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
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 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 08 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 25 Day
Last modified on
2011 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006311

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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