UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized, controlled trial of thel effect of luseogliflozin in type 2 diabetic patients with fattiy liver
Title of the study (Brief title)	Randomized, controlled trial of thel effect of luseogliflozin in type 2 diabetic patients with fattiy liver
Region	Japan

Condition
Condition	type 2 diabetic patients with fatty liver
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of whether fatty liverl is improved by luseogliflozin in type 2 diabetic patients with fatty liver.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A liver attenuation index at unen- hanced CT 24 week after administration
Key secondary outcomes	liver enzyme, fasting plasma glucose ,and HbA1c 24week after administration

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	luseogliflozin
Interventions/Control_2	metformin
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1.patient with type 2 diabetes 2.patient diagnosed fatty liver by abdominal sonography
Key exclusion criteria	1.patients with renal failure 2.patients who have had cerebral infarction 3.patients who have had myocardial infarction 4.patients who is administered diuretics 5.patients who have dehydration 6.patient who is inadequate for this trial
Target sample size	40

Research contact person
Name of lead principal investigator	Takashi Shibuya
Organization	Ichinomiyanishi hospital
Division name	Department of Endocrinology and Diabetes
Address	Ichinomiya, Japan
TEL	0586-48-0077
Email	shibuyan@csc.jp

Public contact
Name of contact person	Takashi Shibuya
Organization	Ichinomiyanishi hospital
Division name	Department of Endocrinology and Diabetes
Address	Ichinomiya, Japan
TEL	0586-48-0077
Homepage URL
Email	shibuyan@csc.jp

Sponsor
Institute	Ichinomiyanichi hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2015 Year 02 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 01 Month 05 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 12 Month 30 Day
Last modified on	2018 Year 01 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018688