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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016090
Receipt No. R000018688
Scientific Title Randomized, controlled trial of thel effect of luseogliflozin in type 2 diabetic patients with fattiy liver
Date of disclosure of the study information 2015/02/01
Last modified on 2018/01/01

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Basic information
Public title Randomized, controlled trial of thel effect of luseogliflozin in type 2 diabetic patients with fattiy liver
Acronym Randomized, controlled trial of thel effect of luseogliflozin in type 2 diabetic patients with fattiy liver
Scientific Title Randomized, controlled trial of thel effect of luseogliflozin in type 2 diabetic patients with fattiy liver
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Shibuya
Organization Ichinomiyanishi hospital
Division name Department of Endocrinology and Diabetes
Zip code
Address Ichinomiya, Japan
TEL 0586-48-0077
Email shibuyan@csc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Shibuya
Organization Ichinomiyanishi hospital
Division name Department of Endocrinology and Diabetes
Zip code
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)

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
2015 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2015 Year 01 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000018688

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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