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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012462
Receipt No. R000013012
Scientific Title Effects of bezafibrate and fenofibrate on insulin sensitivity in patients with type 2 diabetes mellitus by the glucose clamp technique and the meal tolerance test.
Date of disclosure of the study information 2013/12/02
Last modified on 2016/12/04

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Basic information
Public title Effects of bezafibrate and fenofibrate on insulin sensitivity in patients with type 2 diabetes mellitus by the glucose clamp technique and the meal tolerance test.
Acronym Effects of bezafibrate and fenofibrate on insulin sensitivity in patients with type 2 diabetes mellitus.
Scientific Title Effects of bezafibrate and fenofibrate on insulin sensitivity in patients with type 2 diabetes mellitus by the glucose clamp technique and the meal tolerance test.
Scientific Title:Acronym Effects of bezafibrate and fenofibrate on insulin sensitivity in patients with 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 verify the effects of bezafibrate and fenofibrate on peripheral insulin resistance by the glucose clamp technique and on postprandial glucose metabolism tby the meal tolerance test in Japanese patoents with type 2 diabetes mellitus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of glucose infusion rate during euglycemic-hyperinsulinemic clamp and improvement of HbA1c and postprandial blood glucose.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bezafibrate
Fenofibrate
Interventions/Control_2 Bezafibrate was not administered.
Fenofibrate was not administered.
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 HbA1c 6.0-9.0%
Key exclusion criteria Type 1 diabetes mellitus, pancreatic disease, liver disease, renal failure, or those taking diabetogenic medications such as corticosteroids
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Ohkura
Organization Tottori University Faculty of Medicine
Division name Division of Cardiovascular Medicine, Endocrinology and Metabolism
Zip code
Address Nishi-chou 36-1, Yonago, Tottori 683-8504, Japan.
TEL 0859-38-6517
Email ohkura@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Shiochi
Organization Tottori University Faculty of Medicine
Division name Division of Cardiovascular Medicine, Endocrinology and Metabolism
Zip code
Address Nishi-chou 36-1, Yonago, Tottori 683-8504, Japan.
TEL 0859-38-6517
Homepage URL
Email hideki-shiochi.1028@beetle.ocn.ne.jp

Sponsor
Institute Division of Cardiovascular Medicine, Endocrinology and Metabolism, Department of Molecular Medicine and Therapeutics, Tottori University Faculty of Medicine
Institute
Department

Funding Source
Organization Tottori University Faculty of Medicine
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

Other administrative information
Date of disclosure of the study information
2013 Year 12 Month 02 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 Enrolling by invitation
Date of protocol fixation
2009 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 12 Month 02 Day
Last modified on
2016 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013012

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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