UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effective and safe examination of Luseogliflozin for patients with fatty liver merger type II diabetes mellitus
Title of the study (Brief title)	Effective and safe examination of Luseogliflozin for patients with fatty liver merger type II diabetes mellitus
Region	Japan

Condition
Condition	fatty liver merger type II diabetes mellitus
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the Japanese type II diabetes mellitus patients complicated with fatty liver, we examine efficacy and safety when we gave Luseogliflozin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. It is the amount of change of 24 weeks after the dosage from a baseline of HbA1c 2.It is the rate of change of 24 weeks after the dosage from the baseline of the fat ratio in the liver
Key secondary outcomes	1.A blood sugar parameter:HbA1c(other than 24 weeks time),fasting plasma glucose, fasting CPR, fasting insulin, HOMA2-B, HOMA2-S 2.Liver function parameter:AST, ALT, gamma-GTP, ALP, LDH, Alb, T-Bil, TP 3.A metabolic parameter concerned:The weight, the stomach neighborhood, SBP, DBP, TG, LDL-C, HDL-C, TC, FFA, Non-HDL-C,uric acid 4.Others:Ratio,fatty liver,liver fibrosis evaluation score (FLI,FIB-4 index,NFS,AAR) of the subject whom metabolic syndrome improved,type IV collagen 7S,ferritin,Mac-2bp

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Luseogliflozin tab. 2.5mg/day
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)The patient that an agreement was provided in a document than the person about the participation of this study 2) Age is a patient of (at the time of the document agreement acquisition) 20 years old or older 3) A patient having less than 8.5% of HbA1c (NGSP level) of the observation period more than 6.5% 4) The patient who carries out a constant diet cure continuously for more than start eight weeks for the observation period 5) The patient who does not use a diabetes therapeutic drug for more than start eight weeks for the observation period or the patient who uses diabetes therapeutic drug one drug or two drugs at a constant use, dose continuously for more than start eight weeks for the observation period 6) A patient (satisfying higher than following two items) that fatty liver was doubted by abdominal ultrasonography Rise in echo level of the liver parenchyma Upswing in liver kidney contrast Deep part decrement Obnubilation of the vessels in the liver
Key exclusion criteria	1)A diabetic except the type 2 2)The patient who corresponds to the taboo in the attached document of Luseogliflozin 3)The patient who is complicated with a serious renal damage 4)A patient with BMI less than 22kg/m2 5)Is the patients using Insulin, GLP-1 receptor agonist, SGLT2 inhibitor or Thiazolidine within eight weeks for observation period before initiation 6)Viral hepatitis (HBs antigen positive, HCV antibody positive), autoimmune hepatitis, the patients with primary biliary cirrhosis 7)Ascites, hepatic encephalopathy, the patients with the jaundice 8)The patients who put on strong magnetic substance and an electronic device including the body such as pacemakers 9)A pregnant woman, nursing mother, the patients who may be pregnant 10)The patients whom drinking that is the way the quantity of excessive alcohol goes is found in 11)By confirmation of the accumulation situation of intrahepatic iron by Chie Malle Coe T2*W1 of the MRI imaging, the evaluation of the intrahepatic fat ratio is clearly difficulty and the judged patient 12)The patients who, in addition, judged that study doctor attending was inadequate
Target sample size	40

Research contact person
Name of lead principal investigator	Takeshi Osonoi
Organization	Nakakinen Clinic
Division name	Internal medicine
Address	745-5,Nakadai,Naka,Ibaraki
TEL	029-353-2800
Email	t-osonoi@kensei-kai.com

Public contact
Name of contact person	Kensuke Ofuchi
Organization	Practice part
Division name	Clinical Research Department
Address	745-5,Nakadai,Naka,Ibaraki
TEL	029-353-2800
Homepage URL
Email	k-ofuchi@kensei-kai.com

Sponsor
Institute	Nakakinen Clinic
Institute
Department

Funding Source
Organization	Taisho Toyama Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	那珂記念クリニック（茨城県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2017 Year 05 Month 31 Day
Date of closure to data entry	2017 Year 06 Month 15 Day
Date trial data considered complete	2017 Year 06 Month 30 Day
Date analysis concluded	2017 Year 08 Month 31 Day

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

Management information
Registered date	2016 Year 02 Month 18 Day
Last modified on	2017 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024321