UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013747 |
|---|---|
| Receipt number | R000016043 |
| Scientific Title | Investigation of SGLT2 inhibitors for normal glucose tolerance |
| Date of disclosure of the study information | 2014/05/15 |
| Last modified on | 2015/04/17 14:46:12 |
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Basic information
Public title
Investigation of SGLT2 inhibitors for normal glucose tolerance
Acronym
Investigation of SGLT2 inhibitors for normal glucose tolerance
Scientific Title
Investigation of SGLT2 inhibitors for normal glucose tolerance
Scientific Title:Acronym
Investigation of SGLT2 inhibitors for normal glucose tolerance
Region
| Japan |
Condition
Condition
normal glucose tolerance
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect on the metabolism of glucose tolerance when the normal person is taking SGLT2 inhibitors
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
parameter of insulin secretion(Insulinogenic index, HOMA-beta, AUC-IRI)
parameter ofinsulin sensitivity (HOMA-R, Composite indexGIR)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Ipragliflozin 50mg 7days
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
| 20 | years-old | <= |
Age-upper limit
| 61 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese having normal glucose tolerance
2 obtained written informed consent
Key exclusion criteria
1) Type 1 DM (including SPIDDM)
2) Allergy for SGLT2 or Ipragliflozin
3) severe liver dysfunction
4) severe renal dysfunction
5) severe cardiac dysfunction
6) less than 20 years or over 61 years
7) pregnancy or breast feeding
8) mental retardation or dementia
9) systematic steroid administered
10) other inappropriate persons judged by investigators
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 Endocrinoplogy
Zip code
Address
7-5-1,Kusunoki-Cho, Chuo-Ku, Kobe
TEL
078-382-5861
kzhskskgc@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 Endocrinoplogy
Zip code
Address
7-5-1Kusunoki-Cho, Chuo-Ku, Kobe
TEL
078-382-5861
Homepage URL
kzhskskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Dianetes and Endocrinolohgy
Institute
Department
Personal name
Funding Source
Organization
Donation
Organization
Division
Category of Funding Organization
Other
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 | 05 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | 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 | 04 | Month | 17 | Day |
Last modified on
| 2015 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016043
