UMIN-CTR Clinical Trial

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
Email	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
Email	jojima@dokkyomed.ac.jp

Sponsor
Institute	Department of Endocrinology and Metabolism, Dokkyo Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050706