UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012914 |
|---|---|
| Receipt number | R000015028 |
| Scientific Title | Investigation of incretin's effect using clamp method |
| Date of disclosure of the study information | 2014/01/21 |
| Last modified on | 2014/01/21 21:37:24 |
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Basic information
Public title
Investigation of incretin's effect using clamp method
Acronym
Kobe Insulin Clearance Study
Scientific Title
Investigation of incretin's effect using clamp method
Scientific Title:Acronym
Kobe Insulin Clearance Study
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the incretin-related drug's effect on insulin / CPR ratio of the first phase of the hyperglycemic clamp
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the ratio of the area under the curve of IRI / CPR under first phase of hyperglycemic clamp
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
hyperglycemic clamp without pre-treatment
Interventions/Control_2
hyperglycemic clamp after 30 min Lixisenatide 20 micro g SI
Interventions/Control_3
hyperglycemic clamp after sitagliptin 50 mg PO for 7days
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult NGT
Key exclusion criteria
1) drug allergy for Lixisenatide or Sitagliptin
2) Liver or renal impairment
3) Pregmant or breast feeding
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University School of Medicine
Division name
Diabetes and Endocrinology
Zip code
Address
7-5-1Kusunoki-Cho, Chuo-Ku, Kobe
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University School of Medicine
Division name
Diabetes and Endocrinology
Zip code
Address
7-5-1Kusunoki-Cho, Chuo-Ku, Kobe
TEL
078-382-5861
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
kobe university School of medicine
Diabetes and Endocrinology
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
| 2014 | Year | 01 | Month | 21 | 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
| 2014 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 21 | 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
| 2014 | Year | 01 | Month | 21 | Day |
Last modified on
| 2014 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015028
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
