UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043716 |
|---|---|
| Receipt number | R000049621 |
| Scientific Title | A prospective, multicenter, observational study of the effects of SGLT2 inhibitors/ SPPARMalpha combination therapy on liver function in patients with type 2 diabetes and dyslipidemia |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2025/03/28 16:50:59 |
* 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
A prospective, multicenter, observational study of the effects of SGLT2 inhibitors/ SPPARMalpha combination therapy on liver function in patients with type 2 diabetes and dyslipidemia
Acronym
PEMA2i
Scientific Title
A prospective, multicenter, observational study of the effects of SGLT2 inhibitors/ SPPARMalpha combination therapy on liver function in patients with type 2 diabetes and dyslipidemia
Scientific Title:Acronym
PEMA2i
Region
| Japan |
Condition
Condition
type 2 diabetes and dyslipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effects of SGLT2 inhibitors/ SPPARMalpha combination therapy on liver function in patients with type 2 diabetes and dyslipidemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in ALT from baseline at 52 weeks post-treatment
Key secondary outcomes
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 dyslipidemia who need SGLT2 inhibitors and pemafibrate
2. Patients who are older than 20 years old at the time of obtaining consent
3. Patients whose ALT within the last 3 months before consent is beyond the normal range
4. Patients who have given written consent for this study
Key exclusion criteria
1. Patients with contraindications to SGLT2 inhibitors and/or pemafibrate
2. Patients receiving SGLT2 inhibitors and/or pemafibrate
3. Patients who judged unsuitable for this study by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology
Zip code
889-1692
Address
5200, Kihara, Miyazaki, Miyazaki, Japan
TEL
0985-85-9121
intron@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology
Zip code
889-1692
Address
5200, Kihara, Miyazaki, Miyazaki, Japan
TEL
0985-85-9121
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Kowa Company.Ltd.
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
Research Support Section, General Affairs Division, Faculty of Medicine, University of Miyazaki
Address
5200, Kihara, Miyazaki, Miyazaki, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.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
宮崎大学医学部付属病院 糖尿病内科、肝臓内科
日南市立中部病院
宮崎県立宮崎病院
宮永病院
池井病院
京町共立病院
たまきクリニック
古賀総合病院
古賀駅前クリニック
延岡市医師会病院
千代田病院
宮崎東病院
宮崎県立日南病院
きよひで内科クリニック
のま内科クリニック
平和台病院
延岡共立病院
城南病院
鶴田病院
平和台病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | 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
| 2021 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 10 | 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
Study design:
A prospective, multicenter, observational study
Enrollment period:
After the approval of the Ethics Committee to December 31, 2022
Methods:
Comparison of evaluation value before versus 52 weeks after SGLT2 inhibitors/ SPPARMalpha combination therapy
Parameters:
blood pressure, blood glucose, HbA1c, CPR, TG, HDL-C, LDL-C, TC, AST, gammaGTP, ALP, Cr, CK, uric acid,Fatty Liver index, Fib-4 index, Type 4 collagen 7S, hyaluronic acid, M2BPGi, ketone body fraction, GDF15, FGF21, LEAP2, abdominal ultrasonography, fibroscan
Management information
Registered date
| 2021 | Year | 03 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049621
