UMIN-CTR Clinical Trial

Basic information
Public title	The impact of pemafibrate on hypertriglyceridemia in patients with type 2 diabetes: A prospective cohort study.
Acronym	The impact of pemafibrate on hypertriglyceridemia in patients with type 2 diabetes: A prospective cohort study.
Scientific Title	The impact of pemafibrate on hypertriglyceridemia in patients with type 2 diabetes: A prospective cohort study.
Scientific Title:Acronym	The impact of pemafibrate on hypertriglyceridemia in patients with type 2 diabetes: A prospective cohort study.
Region	Japan

Condition
Condition	dyslipidemi
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effects of adding pemafibrate or switching other fibrates to pemafibrate on lipid /glucose metabolism and liver/renal function in patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Changes of TG and HDL-C before and after administration of pemafibrate
Key secondary outcomes	1)total lipid metabolism (remnant, sd-LDL, etc) 2)Liver function 3)Renal function 4)Body weight, Body mass index, Abdominal circumference 5)Fasting plasma glucose, HbA1c, insulin sensitivity and insulin secretion 6)Blood pressure 7)Adverse event 8)Influencing factors on lipid metabolism, liver/renal function, and glucose metabolism 9)Variation of blood and urinary examination including lipid metabolism, as well as abdominal ultrasound findings between pemafibrate group and control

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with type 2 diabetes and hypertriglyceridemia who are treated in Hokkaido University or cooperated hospitals from June 2019 to March 2020. 2)Patients who are going to be treated with pemafibrate or switched from other fibrates to pemaribrate. 3)Patients who have been treated with fibrate without switching to pemafibrate or taking no medication over a year. 4) over 20 years old 5) Written informed consent
Key exclusion criteria	Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Miyoshi
Organization	Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name	Division of Diabetes and Obesity
Zip code	060-8638
Address	Nishi 7, Kita 15, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-8192
Email	hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Miyoshi
Organization	Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name	Division of Diabetes and Obesity
Zip code	060-8638
Address	Nishi 7, Kita 15, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-8192
Homepage URL
Email	hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido University Hospital Clinical Research Management Department
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
Tel	011-706-7636
Email	crjimu@med.hokudai.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	2019 Year 07 Month 16 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	650
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	2019 Year 07 Month 16 Day
Date of IRB	2019 Year 07 Month 16 Day
Anticipated trial start date	2019 Year 07 Month 16 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 09 Month 30 Day

Other
Other related information	None

Management information
Registered date	2019 Year 07 Month 16 Day
Last modified on	2022 Year 08 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042620