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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023044
Receipt No. R000026558
Scientific Title The efficacy and safety in canaglifrozin therapy for diabetes complicated by non-alcoholic fatty liver disease.
Date of disclosure of the study information 2016/10/21
Last modified on 2018/12/10

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Basic information
Public title The efficacy and safety in canaglifrozin therapy for diabetes complicated by non-alcoholic fatty liver disease.
Acronym The efficacy of Canaglifrozin for NAFLD.
Scientific Title The efficacy and safety in canaglifrozin therapy for diabetes complicated by non-alcoholic fatty liver disease.
Scientific Title:Acronym 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
1st name
Middle name
Last name Yosito Itoh
Organization Kyoto prefetural University of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
1st name
Middle name
Last name Yuya Seko
Organization Kyoto prefetural University of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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)

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
2016 Year 10 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.2147/DMSO.S184767
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 Completed
Date of protocol fixation
2016 Year 10 Month 12 Day
Date of IRB
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

Other
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

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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