UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009641 |
|---|---|
| Receipt number | R000011309 |
| Scientific Title | Evaluation of the influence of Vildagliptin on chorioretinal blood flow in patients with diabetic retinopathy |
| Date of disclosure of the study information | 2012/12/31 |
| Last modified on | 2013/12/27 16:59:07 |
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Basic information
Public title
Evaluation of the influence of Vildagliptin on chorioretinal blood flow in patients with diabetic retinopathy
Acronym
Evaluation of the influence of Vildagliptin on chorioretinal blood flow in patients with diabetic retinopathy
Scientific Title
Evaluation of the influence of Vildagliptin on chorioretinal blood flow in patients with diabetic retinopathy
Scientific Title:Acronym
Evaluation of the influence of Vildagliptin on chorioretinal blood flow in patients with diabetic retinopathy
Region
| Japan |
Condition
Condition
diabetic retinopathy
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the influences of vildagliptin or other oral hypoglycemic drugs on chorioretinal blood flow and other structural and functional visual outcomes in patients with type 2 diabetes and diabetic retinopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
chorioretinal blood flow
Key secondary outcomes
best corrected visual acuity, intraocular pressure, central retinal thickness, HbA1c, fasting blood glucose
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Add each treatment for 6 months.
1) vildagliptin 50 or 100mg/day
Interventions/Control_2
2) other oral hypoglycemic drugs except anti-dipeptidyl peptidase-4 (DDP-4) inhibitor
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
1. Type 2 diabetic patients who meet the following requirements
1) Diabetic retinopathy requiring treatment
2) 6.9%<=HbA1c<=11.0%
3) No prior treatment using DDP-4 inhibitor
4) No change of oral hypoglycemic drugs for 3 months prior
2. Patients over 20 years-old.
3. Patients who have been informed and have understood the full explanation of this study, and have agreed and given prior written consent.
Key exclusion criteria
1. Type 1 diabetes, diabetic ketoacidosis or diabetic coma
2. Severe liver or kidney dysfunction
3. Severe infection or traumatic injury
4. In a perioperative period of major surgery
5. Anti-glutamic acid decarboxylase (GAD) antibody>=10U/ml
6. Poorly controlled hypertension; systolic blood pressure>=160mmHg or diastolic blood pressure>=100mmHg
7. Pregnant female, female with possibility of pregnancy and breast-feeding female
8. History of hypersensitivity to targeted medication
9. History of severe cardiovascular or cerebrovascular disease in 6 months
10. Any other factors that may disqualify the patient
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kitaoka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Ophthalmology & Visual Sciences
Zip code
Address
1-7-1 Sakamoto, Nagasaki city, Japan
TEL
095-819-7345
tkitaoka@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Maekawa |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Ophthalmology & Visual Sciences
Zip code
Address
1-7-1 Sakamoto, Nagasaki city, Japan
TEL
095-819-7345
Homepage URL
maekaway@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Biomedical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1. Department of Metabolism/Diabetes and Clinical Nutrition, Nagasaki University Hospital
2. Department of Ophthalmology, Nagasaki University Hospital
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
長崎大学病院（長崎県）/Nagasaki University Hospital
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 31 | 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
| 2012 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | 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
Management information
Registered date
| 2012 | Year | 12 | Month | 26 | Day |
Last modified on
| 2013 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011309
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
