UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044389 |
|---|---|
| Receipt number | R000050706 |
| Scientific Title | Examination of reduction of hepatic fat mass and hepatic fibrosis inhibitory effect of pemafibrate in type 2 diabetic patients with hyperlipidemia and non-alcoholic fatty liver |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2021/06/01 11:02:41 |
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Basic information
Public title
Examination of reduction of hepatic fat mass and hepatic fibrosis inhibitory effect of pemafibrate in type 2 diabetic patients with hyperlipidemia and non-alcoholic fatty liver
Acronym
Examination of reduction of hepatic fat mass and hepatic fibrosis inhibitory effect of pemafibrate in type 2 diabetic patients with hyperlipidemia and non-alcoholic fatty liver
Scientific Title
Examination of reduction of hepatic fat mass and hepatic fibrosis inhibitory effect of pemafibrate in type 2 diabetic patients with hyperlipidemia and non-alcoholic fatty liver
Scientific Title:Acronym
Expectation Trial
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effect of pemafibrate on reducing hepatic fat mass and suppressing hepatic fibrosis in type 2 diabetic patients with hyperlipidemia and NAFLD using FibroScan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of changes in liver steatosis by controlled attenuation parameter(CAP) and liver fibrosis measurement (LSM) in Fibro scan
Key secondary outcomes
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pemafibrate group
Interventions/Control_2
control group
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Type 2 diabetic patients with NAFLD with inadequate lipid control despite being treated with diet, nursing home, or diabetes medication (HbA1c 7.0% or higher)
2)Over 20 years old and less than 80 years old
3)Sex unquestioned
4)Patients with no history of cardiovascular disease
5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization.
6)The patient who gives a written informed
Key exclusion criteria
1)Type 1 diabetes
2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges)
3)A pregnant woman and/or a woman under breast-feeding
4)Impaired kidney function (serum creatinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
5)Diabetic proliferative retinopathy
6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug
7)No treatment with other fibrate
8)Patient with intolerance of medical reasons by doctor.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Teruo |
| Middle name | |
| Last name | Jojima |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL
0282872150
jojima@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Teruo |
| Middle name | |
| Last name | Jojima |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL
0282872150
Homepage URL
jojima@dokkyomed.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism,
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Endocrinology and Metabolism,
Dokkyo Medical University
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
Dokkyo Medical University
Address
880kita-kobayashi,Mibu,Tochigi,Japan
Tel
0282-87-2275
r-kenkyu@dokkyomed.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
| 2021 | Year | 06 | 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 | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Last modified on
| 2021 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050706
