UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045957 |
|---|---|
| Receipt number | R000052452 |
| Scientific Title | To evaluate the efficacy of once-weekly DPP-4 inhibitor:Omarigliptin for liver function of type 2 diabetic patients with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis |
| Date of disclosure of the study information | 2021/11/06 |
| Last modified on | 2025/05/06 09:50:50 |
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Basic information
Public title
To evaluate the efficacy of once-weekly DPP-4 inhibitor:Omarigliptin for liver function of type 2 diabetic patients with NAFLD/NASH
Acronym
To evaluate the efficacy of Omarigliptin for liver function of type 2 diabetic patients with NAFLD/NASH
Scientific Title
To evaluate the efficacy of once-weekly DPP-4 inhibitor:Omarigliptin for liver function of type 2 diabetic patients with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis
Scientific Title:Acronym
To evaluate the efficacy of Omarigliptin for liver function of type 2 diabetic patients with NAFLD/NASH
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of once-weekly DPP-4 inhibitor:Omarigliptin for liver function of type 2 diabetic patients with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fasting blood glucose,HbA1c and liver function are set to be measured at baseline and once at 3 months for 36 months.
Abdominal ultrasonography is set to be examined at baseline and once at 6 months for 36 months.
Key secondary outcomes
Body mass index(BMI),body pressure,immunoreactive insulin(IRI),homeostasis model assessment for insulin resistance(HOMA-IR),high-sensitivity C-reactive protein(hsCRP) and lipid function are set to be measured at baseline and once at 3 months for 36 months.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Active treatment with omarigliptin 25mg/week for 36 months
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)Type 2 diabetes
2)Diet and exercise are well performed
3)Understanding of the study procedures and consenting to it by signatures
Key exclusion criteria
1)Pregnant or being pregnant within the study
2)Contraindication with Dipeptidyl peptidase 4 inhibitor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Hattori |
Organization
Foundation Health Medicine Association Tohto Clinic
Division name
Department of Diabetes and Metabolism
Zip code
102-0094
Address
4-1 Kioi-Cho,Chiyoda-Ku,Tokyo,102-0094,Japan
TEL
03-3239-0301
s-hattori@kenkoigaku.or.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Hattori |
Organization
Foundation Health Medicine Association Tohto Clinic
Division name
Department of Diabetes and Metabolism
Zip code
102-0094
Address
4-1 Kioi-Cho,Chiyoda-Ku,Tokyo,102-0094,Japan
TEL
03-3239-0301
Homepage URL
s-hattori@kenkoigaku.or.jp
Sponsor or person
Institute
Department of Diabetes and Metabolism,Tohto Clinic
Institute
Department
Personal name
Funding Source
Organization
None
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
REC,Tohto Clinic
Address
4-1 Kioi-Cho,Chiyoda-Ku,Tokyo,102-0094,Japan
Tel
03-3239-0301
rinri-tohto@kenkoigaku.co.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 | 11 | Month | 06 | 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
26
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052452
