UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005307 |
|---|---|
| Receipt number | 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 11:52:02 |
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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
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
sshimoda@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006311
