UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007687 |
|---|---|
| Receipt number | R000009067 |
| Scientific Title | Jikei-Vildagliptin and sitagliptin with CGM TO Real blood glucose control In type 2 diAbetes |
| Date of disclosure of the study information | 2012/04/08 |
| Last modified on | 2012/10/08 20:10:34 |
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Basic information
Public title
Jikei-Vildagliptin and sitagliptin with CGM TO Real blood glucose control In type 2 diAbetes
Acronym
J-VICTORIA
Scientific Title
Jikei-Vildagliptin and sitagliptin with CGM TO Real blood glucose control In type 2 diAbetes
Scientific Title:Acronym
J-VICTORIA
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the differences in glucose variablity under treatmants by sitagliptin or sitagliptin using CGM in type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
glucose variablity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sitagliptin
Interventions/Control_2
vildagliptin
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)HbA1c 6.5%-9.0% was not achieved after treatment by life style intervention or anti diabetes drugs for at least 1 month.
2) Given informed consent
Key exclusion criteria
1) type 1 diabetes
2) had ketosis or coma within 6 month
3) after severe infection, operation or injury
4) past history of operation or ileus
5) has colon disorder
6) has Roemheld's syndrome, hernia or stenosis of colon
7) is pregnancy or chance of pregnant
8) impaired renal function(CCR>50ml/min, Serum Cr>1.5mg/dL for male, >1.3mg/dL for female)
9) severe liver damage
10) Under insulin treatment
11) Under treatment by other anti-diabetic drugs (if these drugs were stopped one month prior, the subject can participate this study)
12) Has allergy to DPP-4 inhibitor
13) Patient who was considered to be appropriate to this study by attending physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | RIMEI NISHIMURA |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code
Address
3-25-8 Nishishinbashi, Minatoku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code
Address
TEL
03-3433-1111
Homepage URL
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22867630
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
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 05 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 07 | Day |
Last modified on
| 2012 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009067
| 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 |
