UMIN-CTR Clinical Trial

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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