UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048030 |
|---|---|
| Receipt number | R000054744 |
| Scientific Title | Effects of tofogliflozin treatment on suppression of nocturia and promotion of urinary sodium excretion. |
| Date of disclosure of the study information | 2022/06/11 |
| Last modified on | 2024/07/20 20:04:29 |
* 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
Effects of tofogliflozin treatment on suppression of nocturia and promotion of urinary sodium excretion.
Acronym
Effects of tofogliflozin treatment on suppression of nocturia and promotion of urinary sodium excretion.
Scientific Title
Effects of tofogliflozin treatment on suppression of nocturia and promotion of urinary sodium excretion.
Scientific Title:Acronym
Effects of tofogliflozin treatment on suppression of nocturia and promotion of urinary sodium excretion.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of switching from other SGLT2 inhibitors to tofogliflozin on nocturia and urinary sodium excretion in type 2 diabetic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in nocturia (number of nighttime urination) and urinary sodium excretion at baseline and 12 weeks after tofogliflozin treatment
Key secondary outcomes
Changes in body weight, BMI, blood pressure, fasting plasma glucose, HbA1c, serum creatinine, eGFR, urinary albumin, LDL-cholesterol, HDL-cholesterol, triglyceride, AST, ALT, gamma-GTP at baseline and 12 weeks after tofogliflozin treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching from other SGLT2 inhibitors to tofogliflozin, and taking 20 mg of tofogliflozin once a day for 12 weeks
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
Type 2 diabetic patients who are taking any SGLT2 inhibitors other than tofogliflozin
Key exclusion criteria
1) Type 2 diabetic patients who have an allergy against SGLT2 inhibitors
2) Type 2 diabetic patients who are pregnant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Fujita |
Organization
Akita University Graduate School of Medicine
Division name
Department of Metabolism and Endocrinology
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-884-6769
hirofuji@gipc.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Fujita |
Organization
Akita University Graduate School of Medicine
Division name
Department of Metabolism and Endocrinology
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-884-6769
Homepage URL
hirofuji@gipc.akita-u.ac.jp
Sponsor or person
Institute
Department of Metabolism and Endocrinology, Akita University Graduate School of Medicine
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
Akita University Graduate School of Medicine Ethics Committee
Address
1-1-1 Hondo, Akita
Tel
018-884-6461
soken@hos.akita-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
秋田大学医学部附属病院（秋田県）、本荘第一病院（秋田県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 11 | 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
36
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because of the manuscript in preparation, the publication of the study results is delayed.
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
| 2022 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054744
