UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016090 |
|---|---|
| Receipt number | R000018688 |
| Scientific Title | Randomized, controlled trial of thel effect of luseogliflozin in type 2 diabetic patients with fattiy liver |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2018/01/01 11:22:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized, controlled trial of thel effect of luseogliflozin in type 2 diabetic patients with fattiy liver
Acronym
Randomized, controlled trial of thel effect of luseogliflozin in type 2 diabetic patients with fattiy liver
Scientific Title
Randomized, controlled trial of thel effect of luseogliflozin in type 2 diabetic patients with fattiy liver
Scientific Title:Acronym
Randomized, controlled trial of thel effect of luseogliflozin in type 2 diabetic patients with fattiy liver
Region
| Japan |
Condition
Condition
type 2 diabetic patients with fatty liver
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of whether fatty liverl is improved by luseogliflozin in type 2 diabetic patients with fatty liver.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A liver attenuation index at unen- hanced CT 24 week after administration
Key secondary outcomes
liver enzyme, fasting plasma glucose ,and HbA1c 24week after administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
luseogliflozin
Interventions/Control_2
metformin
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.patient with type 2 diabetes
2.patient diagnosed fatty liver by abdominal sonography
Key exclusion criteria
1.patients with renal failure
2.patients who have had cerebral infarction
3.patients who have had myocardial infarction
4.patients who is administered diuretics
5.patients who have dehydration
6.patient who is inadequate for this trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Shibuya |
Organization
Ichinomiyanishi hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
Ichinomiya, Japan
TEL
0586-48-0077
shibuyan@csc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Shibuya |
Organization
Ichinomiyanishi hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
Ichinomiya, Japan
TEL
0586-48-0077
Homepage URL
shibuyan@csc.jp
Sponsor or person
Institute
Ichinomiyanichi hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2015 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | 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
| 2014 | Year | 12 | Month | 30 | Day |
Last modified on
| 2018 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018688
