UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020141 |
|---|---|
| Receipt number | R000023264 |
| Scientific Title | Defining a novel law of glucose homeostasis under SGLT-2 inhibitor usage by mathematical model approch |
| Date of disclosure of the study information | 2015/12/10 |
| Last modified on | 2016/02/22 11:52:57 |
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Basic information
Public title
Defining a novel law of glucose homeostasis under SGLT-2 inhibitor usage by mathematical model approch
Acronym
Defining a novel law of glucose homeostasis under SGLT-2 inhibitor usage by mathematical model approch
Scientific Title
Defining a novel law of glucose homeostasis under SGLT-2 inhibitor usage by mathematical model approch
Scientific Title:Acronym
Defining a novel law of glucose homeostasis under SGLT-2 inhibitor usage by mathematical model approch
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To generate a new mathematical model of glucose homeostasis in subjects taking a SGLT2 inhibitor
Basic objectives2
Others
Basic objectives -Others
to clarify a new law of glucose homeostasis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine the parameters of the novel mathematical model for glucose homeostasis with the use of OGTT and hyperinsulinemic-euglycemic clamp data identify novel relationship of the parameter
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
SGLT-2 inhibitor (Dapagliflozin) 5 mg per day
5 conseqtive days
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)T2DM who are naive to SGLT-2 inhibitor
2) 20-75 years old
3 having a will to attend this study
Key exclusion criteria
1) pregnant or breast-feeding
2) insulin antibody positive (>10 arbitrary unit )
3) having allergy of skin trouble for oral hypoglycemic agants or insulin
4) type 1 diabetes or other specific type of diabetes
5) severe liver dysfunction (transaminase twice over the normal limit)
6) severe renal dysfunction (eGFR<50)
7) severe heart failure(NYHA>2)
8) long-acting insulin, long-acting GLP-1 RA, or long-acting DPP-4 inhibitor user
9) psychologic disorder
10) recent severe hypoglycemia or hypoglycemia unawareness
11) contraindication of dapagliflozin
others inappropriate for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University School of Medicine
Division name
Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code
Address
7-5-1, Kusunoki-cho, Chioku, Kobe
TEL
81-78-382-5861
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
Division of Diabetes and Endocrinology Department of Internal Medicine
Zip code
Address
7-5-1, Kusunoki-cho, Chioku, Kobe
TEL
81-78-382-5861
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Diabetes and Endocrinology Department of Internal Medicine
Kobe University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | 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
| 2015 | Year | 12 | Month | 10 | Day |
Last modified on
| 2016 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023264
| 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 |
