UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036560 |
|---|---|
| Receipt number | R000041655 |
| Scientific Title | The efficacy and safety of Canagliflozin for the treatment of NAFLD/NASH patients with type2 DM |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2021/06/23 06:05:54 |
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Basic information
Public title
The efficacy and safety of Canagliflozin for the treatment of NAFLD/NASH patients with type2 DM
Acronym
The efficacy and safety of Canagliflozin for the treatment of NAFLD/NASH patients with type2 DM
Scientific Title
The efficacy and safety of Canagliflozin for the treatment of NAFLD/NASH patients with type2 DM
Scientific Title:Acronym
The efficacy and safety of Canagliflozin for the treatment of NAFLD/NASH patients with type2 DM
Region
| Japan |
Condition
Condition
NAFLD/NASH
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To ezaluate the efficacy and safety of Canagliflozin for NAFLD/NASH patients with type2 DM
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The liver function after Canagliflozin administration for 24weeks
Key secondary outcomes
1. The lipid and glycometabolism after Canagliflozin administration for 24weeks
2. The safety of Canagliflozin
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
Patients were treated with Canagliflozin
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Taking alcohol less than 20g/day
2. NAFLD was diagnosed by liver biopsy or abdominal ultrasonography
Key exclusion criteria
1. pregnant woman or lactating mother
2. poorly controlled heart failure
3. poorly controlled hypertension or diabetes
4. severe renal disorder
5. decompensated liver cirrhosis
6. other liver diseases, including autoimmune hepatitis, primary biliary cholangitis and alcoholic hepatitis, liver failure
7. positive result for hepatitis C antibody, hepatitis B surface antigen and antibody to human immunodeficiency virus type-1
8. hypercarcemia
9. hyperparathyroidism
10. Judged by investigator not to be appropriate for inclusion in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Yoshida |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Division of Gastroenterology
Zip code
270-1196
Address
1715, Kamakari, Inzai, Chiba, 270-1694, Japan
TEL
0476-99-1111
itokawa@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Yoshida |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Division of Gastroenterology
Zip code
270-1196
Address
1715, Kamakari, Inzai, Chiba, 270-1694, Japan
TEL
0476-99-1111
Homepage URL
yuji-y@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Division of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Chiba Hokusoh Hospital
Address
1715, Kamakari, Inzai, Chiba, 270-1694, Japan
Tel
0476-99-1111
araraki@nms.ac.jp
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
| 2019 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 20 | Day |
Last modified on
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041655
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
