UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029609 |
|---|---|
| Receipt number | R000032695 |
| Scientific Title | The investigation of the effectiveness by tofogliflozin on macular edema among the Japanese patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2017/10/19 |
| Last modified on | 2025/04/24 15:15:13 |
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Basic information
Public title
The investigation of the effectiveness by tofogliflozin on macular edema among the Japanese patients with type 2 diabetes mellitus
Acronym
Ehime Macular Edema Study
Scientific Title
The investigation of the effectiveness by tofogliflozin on macular edema among the Japanese patients with type 2 diabetes mellitus
Scientific Title:Acronym
Ehime Macular Edema Study
Region
| Japan |
Condition
Condition
Macular edema
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the usefulness of tofogliflozin among patients with type 2 diabetes mellitus and macular edema.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of CRT at 52 weeks
Key secondary outcomes
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
Tofogliflozin 20mg
Kowa
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes mellitus
20 - 80 years old
Range of HbA1c 6.0% -10.0%
BMI 23 or more
eGFR 30mL/min/1.73m2
Written informed consent was obtained from all patients enrolled in the this study
Key exclusion criteria
History of severe hypoglycemia
Cerebral infaction with paralysis
Repeated genital infection and urinary tract infection
Type 1 diabetes mellitus
Patients with cancer during treatment(excluding no recurrence of cancer)
Aspartate aminotransferase(AST)or alanine transaminase(ALT) 100 IU/L or more
Patients in need of anti-VEGF therapy for diabetic macular edema
Patients in need of pan retinal photocoagulation for diabetic macular edema
Patients with vitreomacular traction observed with OCT
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Shiraishi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Ophthalmilogy
Zip code
7910295
Address
Shitsukawa, Toon, Ehime, Japan
TEL
0899605111
shiraia@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Furukawa |
Organization
Ehime University
Division name
Health Services Center
Zip code
7908577
Address
Bunkyo, Matsuyama, Japan
TEL
0899605283
Homepage URL
shinfuru@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime 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
Graduate School of Medicine
Address
Shitsukawa, Toon, Ehime, Japan
Tel
089960511
rinri@m.ehime-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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 19 | 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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032695
