UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010624 |
|---|---|
| Receipt number | R000012423 |
| Scientific Title | Vildagliptin and biguanide on postprandial blood glucose and vascular endothelial function in type 2 diabetic patients with coronary artery disease |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2016/04/30 10:51:44 |
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Basic information
Public title
Vildagliptin and biguanide on postprandial blood glucose and vascular endothelial function in type 2 diabetic patients with coronary artery disease
Acronym
VIBRATE-J study
Scientific Title
Vildagliptin and biguanide on postprandial blood glucose and vascular endothelial function in type 2 diabetic patients with coronary artery disease
Scientific Title:Acronym
VIBRATE-J study
Region
| Japan |
Condition
Condition
Type 2 diabetic patients with coronary artery disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of vildagliptin and biguanide on postprandial blood glucose and vascular endothelial function in diabetic patients with CAD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of blood glucose, insulin, and lipids
Key secondary outcomes
Changes of vascular endothelial function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vildagliptin
Interventions/Control_2
Metformin
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) Patients with HbA1 >= 6.9% (NGSP) even after dietary and exercise therapies
2) Patients with CAD
3) Patients who give informed consent
4) Patients aged 20 years or older
Key exclusion criteria
1) Patients who has a history of adverse events with vildagliptin or biganide
2) Patients treated with antidiabetes agents
3) Ongoing treatment with insulin
4) Patients with diabetic ketoacidosis or diabetic coma or type 1 diabetes
5) Patients with severe liver dysfunction
6) Patients with moderate or severe renal disorders (creatinine level >= 1.5 mg/dL [men] or >= 1.3 mg/dL [women])
7) Pregnant or nursing women
8) Patients with severe illness
9) Patients who judged as ineligible by clinical investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Shimada |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiology
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
shimakaz@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Shimada |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiology
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
Homepage URL
shimakaz@juntendo.ac.jp
Sponsor or person
Institute
Department of Cardiology, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 01 | 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
| 2013 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
| 2013 | Year | 04 | Month | 30 | Day |
Last modified on
| 2016 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012423
| 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 |
