UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056024 |
|---|---|
| Receipt number | R000064025 |
| Scientific Title | Pemafibrate Add-on theRapy in Type 2 diabetes with MASLD uNdErgoing SGLT2 inhibitoR-Juntendo Shizuoka:PARTNER-JS |
| Date of disclosure of the study information | 2024/11/14 |
| Last modified on | 2024/11/02 11:09:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pemafibrate Add-on theRapy in Type 2 diabetes with MASLD uNdErgoing SGLT2 inhibitoR-Juntendo Shizuoka:PARTNER-JS
Acronym
PARTNER-JS
Scientific Title
Pemafibrate Add-on theRapy in Type 2 diabetes with MASLD uNdErgoing SGLT2 inhibitoR-Juntendo Shizuoka:PARTNER-JS
Scientific Title:Acronym
PARTNER-JS
Region
| Japan |
Condition
Condition
Type 2 diabetes dyslipidemia MASLD
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate anti-MASLD effect of combined therapy of tofogliflozin and pemafibrate in Japanese subjects in type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ALT
Key secondary outcomes
BMI, AST, TG
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age>18yo
2. Subjects with T2D undergoing tofogliflozin treatment
3. TG>150mg/dL(fasting), TG>175mg/dL(casual)
4. MASLD
5. Agreement
Key exclusion criteria
Contraindication for pemafibrate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nomiyama |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
410-2295
Address
1129, Nagaoka, Izunokunishi, Shizuoka, Japan
TEL
0559483111
nomiyama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nomiyama |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
410-2295
Address
1129, Nagaoka, Izunokunishi, Shizuoka, Japan
TEL
0559483111
Homepage URL
nomiyama@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Kowa
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital Clinical Research and Trial Center
Address
1129 Nagaoka, Izunokunishi, Shizuoka
Tel
0559483111
shizuoka.rinri.sibu@juntendo.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
| 2024 | Year | 11 | Month | 14 | 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
| 2024 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 11 | Month | 02 | Day |
Last modified on
| 2024 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064025
