UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026549 |
|---|---|
| Receipt number | R000030489 |
| Scientific Title | Effect of Dapagliflozin for type 2 diabetes mellitus with fatty liver |
| Date of disclosure of the study information | 2017/03/28 |
| Last modified on | 2017/03/31 14:33:24 |
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Basic information
Public title
Effect of Dapagliflozin for type 2 diabetes mellitus with fatty liver
Acronym
Effect of Dapagliflozin for T2DM with fatty liver
Scientific Title
Effect of Dapagliflozin for type 2 diabetes mellitus with fatty liver
Scientific Title:Acronym
Effect of Dapagliflozin for T2DM with fatty liver
Region
| Japan |
Condition
Condition
type 2 DM patients with fatty liver
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dapagliflozin, an SGLT2 inhibitor, was reported to be effective in improving blood glucose levels, body weight loss, liver function, triglyceride, renal function. We studied the effect of Dapagliflozin in case of type 2 diabetes mellitus with fatty liver for 6 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
effect of AST ALT gamma GTP improvement at 6 months administration
Key secondary outcomes
effect of HDL-C LDL-C TG UA Hgb Hct Crea BUN eGFR improvement at 6 months administration
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
type 2 diabetes mellitus with fatty liver
Key exclusion criteria
patients with allergy for Dapagliflozin
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Takaguchi |
Organization
Kagawa prefectural central hospital
Division name
Hepatology
Zip code
Address
1-2-1 takamatsu city Kagawa
TEL
087-811-3333
k.takaguchi@chp-kagawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maki Tanimoto |
Organization
Kagawa prefectural central hospital
Division name
Clinical resarch center
Zip code
Address
1-2-1 takamatsu city Kagawa
TEL
087-811-3333
Homepage URL
rinsyokenkyuu@chp-kagawa.jp
Sponsor or person
Institute
Kagawa prefectural central hospital
Institute
Department
Personal name
Funding Source
Organization
Kagawa prefectural central hospital
Organization
Division
Category of Funding Organization
Local Government
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
| 2017 | Year | 03 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 03 | Month | 14 | Day |
Last modified on
| 2017 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030489
| Research Plan | |
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| 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 |
