UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and safety in canaglifrozin therapy for diabetes complicated by non-alcoholic fatty liver disease.
Title of the study (Brief title)	The efficacy of Canaglifrozin for NAFLD.
Region	Japan

Condition
Condition	Nonalcoholic fatty liver disease type 2 diabetes mellitus
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	No pharmacological therapies have been established for nonalcoholic fatty liver disease (NAFLD). Sodium glucose co-transporter 2 inhibitor (SGLT2I) developed for the treatment of adults with type 2 diabetes mellitus. The aim of this prospective study is to evaluate the efficacy of canaglifrozin (100mg, 12week) in NAFLD patients with type 2 diabetes mellitus.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	serum level of ALT at baseline and end of 12 weeks. The change of ALT between baseline and end of 12 weeks administration.
Key secondary outcomes	serum level of AST, GGT, ALP, HbA1c, fasting glucose, fasting insulin, c peptide, platelet count, uric acid, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, hyaluronic acid, type 4 collagen 7s. waist circumference, NAFIC score, FIB-4 index, FM-fibro index, body composition, LSM, CAP, DEBQ, SF-8TM

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	canaglifrozin 100mg for 12 weeks
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	HbA1c >6.0%, <10.0% Biopsy proven NAFLD (Kliner stage1-3) ALT>30U/L
Key exclusion criteria	administration of SGLT2 inhibitors type 1 diabetes platelet count<100000/microL eGFR<45m/min/1.73m2 diagnosed heart failure or malignancy
Target sample size	20

Research contact person
Name of lead principal investigator	Yosito Itoh
Organization	Kyoto prefetural University of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL	0752515519
Email	yitoh@koto.kpu-m.ac.jp

Public contact
Name of contact person	Yuya Seko
Organization	Kyoto prefetural University of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL	0752515519
Homepage URL
Email	yuyaseko@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto prefetural University of Medicine
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 12 Day
Anticipated trial start date	2016 Year 11 Month 28 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	https://doi.org/10.2147/DMSO.S184767
Results
Other related information

Management information
Registered date	2016 Year 07 Month 06 Day
Last modified on	2018 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026558