UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015873 |
|---|---|
| Receipt number | R000018468 |
| Scientific Title | Comparison of SGLT2 inhibitors versus DPP-4 inhibitors for diabetic macular edema |
| Date of disclosure of the study information | 2014/12/08 |
| Last modified on | 2016/11/01 09:45:15 |
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Basic information
Public title
Comparison of SGLT2 inhibitors versus DPP-4 inhibitors for diabetic macular edema
Acronym
Comparison of SGLT2 inhibitors versus DPP-4 inhibitors for diabetic macular edema
Scientific Title
Comparison of SGLT2 inhibitors versus DPP-4 inhibitors for diabetic macular edema
Scientific Title:Acronym
Comparison of SGLT2 inhibitors versus DPP-4 inhibitors for diabetic macular edema
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the efficacy and safety of SGLT2 inhibitors(Canagliflozin) and DPP-4 ihhibitors(Sitagliptin) in patients with diabetic macular edema
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Mean change from baseline in retinal central foveal thickness using optical coherence tomography (OCT)
Key secondary outcomes
1)Mean change at 3 months and 2 years after administration of canagliflozin or sitagliptin
Glucose
HbA1c
Body weight
Lipid
Blood pressure
Endo-PAT
2) Number of times that were treated with anti-VEGF drugs in 2 years
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Canagliflozin 100mg/day for 3months
Interventions/Control_2
Sitagliptin 50mg/day for 3months
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)before test registration - the meal and exercise cure for one month or more or a meal and an exercise cure, and diabetic medicine and inpatient
2)HbA1c(NGSP):more than 7.0%, less than 14.0%
3)eGFR more than 45ml/min/1.73m 2
4)Type 2 diabetes
5)Pts with written IC
6)Age more than 20, less than 65
7)Diabetic macular edema
Key exclusion criteria
1)Patients treated with photocoagulation, anti-VEGF drugs or steroids to intraocular within 6 months
2)severe ketosis, diabetic coma within 6 months
3)severe infection, before operation, severe trauma
4)severe hepatic dysfunction
5)Patients who use of insulin, GLP-1 receptor agonist or diuretic
6)pregnacy
7)Allergy for sitagliptin, nateglinide,liraglutide and exenatide
8)Patients judged by the investigator to be ineligible for some other reason .
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
naibunpi@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Joe Nagakura |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
jo0806nagakura@hotmail.com
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 08 | 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
| 2014 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 08 | Day |
Last modified on
| 2016 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018468
