UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The improvement effect of liver dysfanction and inhibitory effect of fibrosis marker by sitagliptin or repaglinide treatment for fatty liver(liver dysfunction) patients with type2 diabetes mellitus.
Title of the study (Brief title)	The improvement effect of liver dysfanction and inhibitory effect of fibrosis marker by sitagliptin or repaglinide treatment for fatty liver(liver dysfunction) patients with type2 diabetes mellitus.
Region	Japan

Condition
Condition	Diabetes Mellitus Liver dysfunction
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The improvement effect of both blood sugar and liver function including fatty liver improvement and fibrosis markers inhibition by the sitagliptin treatment in early type 2 diabetes mellitus patients with fatty liver (liver dysfunction) who are not having the existing medical treatment is verified, and the effect of sitagliptin except pancreas is examined.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	NAFIC score(Ferritin, IRI, Type4collagen 7s)
Key secondary outcomes	diagnostic imaging, blood test , adiponecti, GLP-1(Active form), free fatty acid

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A: sitagliptin 50mg QD
Interventions/Control_2	Group B: repaglinide 0.25mg TID
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	1)Patients who have fatty liver by picture evaluation ( abdomen echo check, abdomen CT inspection) 2)Patients who have abnormalities in AST, ALT, or gamma-GTP 3)Patients who have abnormalities in TG, T-CHO, or FFA 4)Patient who have abnormalities in either IV type collagen S or ferritin Patients who fulfilled above 1) and 2)as indispensable condition, and either 3) or 4), or both 3) and 4)
Key exclusion criteria	1) Patients who have renal dysfunction 2) Patients whose medicine or its dosage changed during the study duration if antihypertensive drug, antilipidemial drug or medicine which effects on other liver functions is used. 3) Patients who are considered inappropriate as a target patient by a physician-in-charge
Target sample size	50

Research contact person
Name of lead principal investigator	Shinya Fukunishi
Organization	Osaka Medical College Hospital
Division name	Second internal medicine
Address	2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL	072-683-1211
Email	in2104@poh.osaka-med.ac.jp

Public contact
Name of contact person	Shinya Fukunishi
Organization	Osaka Medical College Hospital
Division name	Second internal medicine
Address	2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL	072-683-1211
Homepage URL
Email	in2104@ph.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College Hospital
Institute
Department

Funding Source
Organization	Osaka Medical College Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka Medical College Hospital, Ishikiriseiki Hospital, Shiroyama Hospital, Sugimoto Clinic, Seikeikai Hospital, Taisyou Hospital, First Towakai Hospital, Hanwasumiyosi General Hospital, Hokusetsu General Hospital
Name of secondary funｄer(s)

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	2014 Year 12 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 07 Month 02 Day
Anticipated trial start date	2012 Year 07 Month 02 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 07 Day
Last modified on	2018 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014647