UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008884 |
|---|---|
| Receipt number | R000010424 |
| Scientific Title | A Step therapy by a premixed insulin therapies in poor control with type 2 diabetes |
| Date of disclosure of the study information | 2012/09/10 |
| Last modified on | 2012/09/09 16:49:33 |
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Basic information
Public title
A Step therapy by a premixed insulin therapies in poor control with type 2 diabetes
Acronym
A Step therapy by a premixed insulin therapies in poor control with type 2 diabetes
Scientific Title
A Step therapy by a premixed insulin therapies in poor control with type 2 diabetes
Scientific Title:Acronym
A Step therapy by a premixed insulin therapies in poor control with type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A premixed insulin is most used in therapy of type 2 diabetes. But,a premixed insulin often occers poor control. In that case, it is not decided what therapy do we use. And combination therapy of insulin and sitagliptin is new expected. We want to comparison between a premixed insulin or basal insulin therapy in type 2 diabetes of poor control by premixed insulin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c before and after intervention
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
change premix insulin to insulin glargine and add sitagliptin
Interventions/Control_2
continue premix insulin and add sitagliptin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
type 2 diabetes
6.5<=HbA1c(JDS)<10.0 or uncontrolable
use premixed insulin for 3 months
Key exclusion criteria
poor hepatitis
Cr>=2.0
use glinide
use two or more kind of insulins
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terauchi |
Organization
yokohama city university school of medicine
Division name
department of endcrinology and metabolism
Zip code
Address
3-9,fukuura,kanazawa-ku,yokohama-city,kanagawa,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
yokohama city university school of medicine
Division name
endcrinology and metabolism
Zip code
Address
yokohama-city,kanagawa,Japan
TEL
Homepage URL
Sponsor or person
Institute
yokohama city university school of medicine
endcrinology and metabolism
Institute
Department
Personal name
Funding Source
Organization
yokohama city university school of medicine
endcrinology and metabolism
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
| 2012 | Year | 09 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 09 | Day |
Last modified on
| 2012 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010424
