UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020331 |
|---|---|
| Receipt number | R000023481 |
| Scientific Title | The potential effect of Dapagliflozin on diabetic macular edema |
| Date of disclosure of the study information | 2015/12/24 |
| Last modified on | 2023/02/10 16:36:53 |
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Basic information
Public title
The potential effect of Dapagliflozin on diabetic macular edema
Acronym
The potential effect of Dapagliflozin on diabetic macular edema
Scientific Title
The potential effect of Dapagliflozin on diabetic macular edema
Scientific Title:Acronym
The potential effect of Dapagliflozin on diabetic macular edema
Region
| Japan |
Condition
Condition
diabetic macular edema, diabetes
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect and safety of Dapagliflozin on diabetic macular edema using with optical coherence tomography (OCT)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of macular edema (the thickness and the area) at 12th week from baseline.
Key secondary outcomes
Glycemic control; e.g. blood glucose, HbA1c
osmotic pressure
serum creatinine, eGFR, urinary albmin creatinine ratio,
the frequency of ophtharmological treatment
The severity and causal relationship with the investigational drug will be tabulated and evaluated for adverse events occurring during the study period.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
subjects giving informed consent to participate in the trial
HbA1c: 6.5-9.5 (NGSP)
age: 20-75
BMI: 22-45
Key exclusion criteria
Refusal or lack of capacity to give informed consent
The contraindications use of Dapagliflozin
History of SGLT2i
eGFR <45mL/min/1.73m2
Anti GAD antibody positive
Pregnant or current Brest feeding
Recent history of cardiovascular events
AST and/or ALT > 3x upper limit of normal
Total bilirubin > 3.0 mg/dL
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Yamazaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5505
masahiro@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Yamazaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5505
Homepage URL
masahiro@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Department of Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca, Ono
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
ESR-15-11160
Org. issuing International ID_1
AstraZeneca, Ono
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Open label, one-arm explanatory study.
Study periods; 12 weeks.
Estimated date of first subject enrolled 1/Feb/2016
Estimated date of last subject completed 31/May/2017
macular edema (the thickness and the area)
Glycemic control; e.g. blood glucose, HbA1c
osmotic pressure
serum creatinine, eGFR, urinary albmin creatinine ratio,
the frequency of ophtharmological treatment
Management information
Registered date
| 2015 | Year | 12 | Month | 24 | Day |
Last modified on
| 2023 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023481
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
