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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003362
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tama-center Mirai Clinic
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003804

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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