UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023044 |
|---|---|
| Receipt number | 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 18:53:07 |
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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
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
yuyaseko@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefetural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026558
