UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054278 |
|---|---|
| Receipt number | R000061984 |
| Scientific Title | Reduction in nocturnal urinary frequency and improvement of fatty liver in SGLT-2 inhibitors: a randomized controlled trial |
| Date of disclosure of the study information | 2024/04/29 |
| Last modified on | 2024/04/28 12:54:25 |
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Basic information
Public title
Reduction in nocturnal urinary frequency and improvement of fatty liver in SGLT-2 inhibitors.
Acronym
Reduction in nocturnal urinary frequency and improvement of fatty liver in SGLT-2 inhibitors.
Scientific Title
Reduction in nocturnal urinary frequency and improvement of fatty liver in SGLT-2 inhibitors: a randomized controlled trial
Scientific Title:Acronym
Reduction in nocturnal urinary frequency and improvement of fatty liver in SGLT-2 inhibitors: a randomized controlled trial
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Various SGLT-2 inhibitors are available, but nocturia complaints may occur on initiation of the same drugs. The aim is to find out which SGLT-2 inhibitor can be used to reduce nocturia.
Improvement of fatty liver has also been reported with SGLT-2 inhibitors, and which SGLT-2 inhibitor is most effective will be investigated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the frequency of nocturnal urine (23:00-6:00)
Key secondary outcomes
Improvement of fatty liver
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prescription of 20 mg of tofogliflozin in men and women with type 2 diabetes
Interventions/Control_2
Prescription of 5 mg of dapagliflozin in men and women with type 2 diabetes
Interventions/Control_3
Prescription of 10 mg of empagliflozin in men and women with type 2 diabetes
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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults of 30 years and over with HbA1c >= 8.0% of type 2 diabetes and metabolic dysfunction associated steatohepatitis (MASH)
Key exclusion criteria
Insulin users
Type 1 diabetes
Mental illness
Liver cirrhosis
Renal failure
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kawahara |
Organization
Shin Komonji Hospital
Division name
Endocrinology and Diabetes
Zip code
800-0057
Address
2-5 Dairishinmachi, Moji, Kitakyushu
TEL
+81-93-391-1001
k-tetsuy@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kawahara |
Organization
Shin Komonji Hospital
Division name
Endocrinology and Diabetes
Zip code
800-0057
Address
2-5 Dairishinmachi, Moji, Kitakyushu
TEL
0933911001
Homepage URL
k-tetsuy@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
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
Shin Komonji Hospital
Address
2-5 Dairishinmachi, Moji, Kitakyushu
Tel
+81-933911001
k-tetsuy@med.uoeh-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
新小文字病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 29 | 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 | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061984
