UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020331
Receipt No. 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 2016/04/11

* 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 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
Email 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
Email masahiro@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Department of Endocrinology and Metabolism
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2015 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
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
2016 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023481

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.