UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013048 |
|---|---|
| Receipt number | R000015225 |
| Scientific Title | The study for efficacy of teneligliptin in non-alcoholic fatty liver disease (NAFLD) with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2014/02/03 |
| Last modified on | 2018/09/10 16:01:53 |
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Basic information
Public title
The study for efficacy of teneligliptin in non-alcoholic fatty liver disease (NAFLD) with type 2 diabetes mellitus
Acronym
The study for efficacy of teneligliptin in non-alcoholic fatty liver disease (NAFLD) with type 2 diabetes mellitus
Scientific Title
The study for efficacy of teneligliptin in non-alcoholic fatty liver disease (NAFLD) with type 2 diabetes mellitus
Scientific Title:Acronym
The study for efficacy of teneligliptin in non-alcoholic fatty liver disease (NAFLD) with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
non-alcoholic 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
To investigate the efficacy of teneligliptin in non-alcoholic fatty liver disease with type 2 diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
improvement in liver stiffness
Key secondary outcomes
improvement in physical findings and laboratory data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of teneligliptin with diet and exercise therapy
Interventions/Control_2
diet and exercise therapy only (and administration of glimepiride as needed)
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) The subjects with fatty liver and more than or equal to 30IU/L of ALT
2) The subjects with more than or equal to 6.0% and less than 8.0% of HbA1c
Key exclusion criteria
1) intake more than 20g/day of ethanol
2) HBsAg and/or HCV Ab positive
3) history of hepatic disease, such as autoimmune liver disease, hemochromatosis and Wilson's disease
4) history of diabetes ketosis and/or diabetic coma
5) during pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Nakajima |
Organization
Sapporo Kosei General Hospital
Division name
Department of hepatology
Zip code
Address
Kita 3 Higashi 8-5, Chuo-ku, Sapporo, Japan
TEL
011-261-5331
t.nakajima@ja-hokkaidoukouseiren.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Nakajima |
Organization
Sapporo Kosei General Hospital
Division name
Department of hepatology
Zip code
Address
Kita 3 Higashi 8-5, Chuo-ku, Sapporo, Japan
TEL
011-261-5331
Homepage URL
t.nakajima@ja-hokkaidoukouseiren.or.jp
Sponsor or person
Institute
Sapporo Kosei General Hospital, Department of Hepatology
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
Kyoto Prefectural University of Medicine, Department of endocrinology and metabolism
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
| 2014 | Year | 02 | Month | 03 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 03 | 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 | 02 | Month | 03 | Day |
Last modified on
| 2018 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015225
