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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009641
Receipt No. 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

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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
Email 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
Email maekaway@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011309

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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