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

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 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


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

Value
https://center6.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