UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004721 |
|---|---|
| Receipt number | R000005619 |
| Scientific Title | Effect of Sitagliptin on Adiponectin and oxidative stress in Diabetic Patients - Japan (START-J study) |
| Date of disclosure of the study information | 2011/01/01 |
| Last modified on | 2013/06/14 14:50:00 |
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Basic information
Public title
Effect of Sitagliptin on Adiponectin and oxidative stress in Diabetic Patients - Japan (START-J study)
Acronym
Effect of Sitagliptin on Adiponectin
Scientific Title
Effect of Sitagliptin on Adiponectin and oxidative stress in Diabetic Patients - Japan (START-J study)
Scientific Title:Acronym
Effect of Sitagliptin on Adiponectin
Region
| Japan |
Condition
Condition
type 2 diabetic patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of Sitagliptin on Adiponectin level
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c, adiponectin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Control (Conventionally normal treatment)
Interventions/Control_2
Sitagliptin treatment
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
The patient with type 2 diabetes mellitus
Key exclusion criteria
1) The patient who takes insulin treatment
2) The patient who takes treatment with thiazolidinediones
3) The patient with severe renal function disorder
4) The patient who takes sulfonylurea medicine more than the following amount
Glimepiride 2mg, Glibenclamide 1.25mg, Gliclazide 40mg
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Hibuse |
Organization
Suita municipal hospital
Division name
metabolic medicine
Zip code
Address
2-13-20, Katayamacho, Suita, Osaka, 564-0082, Japan
TEL
06-6387-3311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Suita municipal hospital
Division name
Internal medicine
Zip code
Address
2-13-20, Katayamacho, Suita, Osaka, 564-0082, Japan
TEL
Homepage URL
Sponsor or person
Institute
Suita municipal hospital
Institute
Department
Personal name
Funding Source
Organization
Suita municipal hospital
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
| 2011 | Year | 01 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 14 | Day |
Last modified on
| 2013 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005619
