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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013747
Receipt No. 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

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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
Email 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
Email kzhskskgc@med.kobe-u.ac.jp

Sponsor
Institute Dianetes and Endocrinolohgy
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016043

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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