UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003362 |
|---|---|
| Receipt number | R000003804 |
| Scientific Title | Multi-centered open-label, observational study of Sitagliptin in West Tokyo Area |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2010/03/21 13:47:18 |
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Basic information
Public title
Multi-centered open-label, observational study of Sitagliptin in West Tokyo Area
Acronym
Sitagliptin add-on to SU study in West Tokyo.
Scientific Title
Multi-centered open-label, observational study of Sitagliptin in West Tokyo Area
Scientific Title:Acronym
Sitagliptin add-on to SU study in West Tokyo.
Region
| Japan |
Condition
Condition
Type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness and safety of Sitagliptin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of HbA1c (%) and body weight.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients. Diet and exercise only or with oral diabetic agents.
Key exclusion criteria
Renal dysfunction ;Creatinin equal or more than 2.0 mg/dl
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaichi Miyakawa, Yuko Watanabe, Hitomi Fujii |
Organization
Tama-center Mirai Clinic
Division name
Internal Medicine
Zip code
Address
1-38-1F Ochiai Tama-city, Tokyo
TEL
042-316-8570
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaichi Miyakawa, Yuko Watanabe, Hitomi Fujii |
Organization
Tama-center Mirai Clinic
Division name
Internal Medicine
Zip code
Address
1-38-1F Ochiai Tama-city, Tokyo
TEL
042-316-8570
Homepage URL
Sponsor or person
Institute
Tama-center Mirai Clinic
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Treat to target HbA1c less than 6.5% and observe the achievement rate, the difference between previous treatment (diet only, SU, dose),change of the pancreas function.
Management information
Registered date
| 2010 | Year | 03 | Month | 21 | Day |
Last modified on
| 2010 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003804
