UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037385 |
|---|---|
| Receipt number | R000042620 |
| Scientific Title | The impact of pemafibrate on hypertriglyceridemia in patients with type 2 diabetes: A prospective cohort study. |
| Date of disclosure of the study information | 2019/07/16 |
| Last modified on | 2022/08/02 21:09:36 |
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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
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
hmiyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042620
