UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004916 |
|---|---|
| Receipt number | R000005850 |
| Scientific Title | Jikei SiTagliptin vs Alpha-glucosidase inhibitor treatment Research by CGM |
| Date of disclosure of the study information | 2011/01/20 |
| Last modified on | 2015/04/26 13:11:40 |
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Basic information
Public title
Jikei SiTagliptin vs Alpha-glucosidase inhibitor treatment Research by CGM
Acronym
J-star
Scientific Title
Jikei SiTagliptin vs Alpha-glucosidase inhibitor treatment Research by CGM
Scientific Title:Acronym
J-star
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 glucose variability under treatment by sitagliptin or voglibose using CGM in type 2 diabetes patients/
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
glucose variability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sitagliptin
Interventions/Control_2
Voglibose
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
type2 diabetes whose HbA1c is >6.5 and <9.0
under life style intervention + ordinal dosage of SU or metformin or alpha-glucosidase inhibitor treatment
Key exclusion criteria
type 1 diabetes
diabetic ketosis
infection
past history of abdominal operation
past history of ileus
renal failure
liver damage
on insulin treatment
past history of allergy against Sitagliptin or Voglibose
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaya Sakamoto |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461 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, Metabolism and Endocrinology Department of Internal Medicine
Zip code
Address
TEL
03-3433-1111
Homepage URL
Sponsor or person
Institute
Jikei University School of Medicine
3-25-8 Nishishimbashi, Minato-ku, Tokyo
105-8461 Japan
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
| 2011 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://online.liebertpub.com/doi/abs/10.1089/dia.2012.0262
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
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
| 2012 | Year | 05 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 20 | Day |
Last modified on
| 2015 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005850
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
