UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015057 |
|---|---|
| Receipt number | R000017514 |
| Scientific Title | Investigation of metabolic change by SGLT2 inhibitors in type 2 diabetes patients. |
| Date of disclosure of the study information | 2014/09/04 |
| Last modified on | 2017/11/26 21:54:29 |
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Basic information
Public title
Investigation of metabolic change by SGLT2 inhibitors in type 2 diabetes patients.
Acronym
Metabolic change by SGLT2 inhibitors.
Scientific Title
Investigation of metabolic change by SGLT2 inhibitors in type 2 diabetes patients.
Scientific Title:Acronym
Metabolic change by SGLT2 inhibitors.
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the metabolic change by SGLT2 inhibitors in type 2 diabetes patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Body composition
Glucose profile
Nitrogen balance
Key secondary outcomes
Body weight
Glycated hemoglobin
Glycated albumin
Lipid profile
Urinary albumin excretion
Urinary protein excretion
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SGLT2 inhibitors
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Men and women who were diagnosed with type 2 diabetes in the diagnostic criteria of the Japan Diabetes Society.
2. Patients determined to require hospitalization for education and diabetes management in Kitasato University Hospital of Endocrinology and Metabolism.
3. Patients who are considered treatment with SGLT2 inhibitors is suitable.
4. Patients who obtained informed consent.
Key exclusion criteria
1. severe ketosis, diabetic coma, or before coma
2. before and not long after surgery,or patients with severe trauma
3. alcohol intake's excessive
4. patients who have a fever of 37.0 degrees or more
5. obvious infection
6. severe renal dysfunction or dialysis patients
7. patients with symptoms of urinary retention, difficulty urinating, anuria, or oliguria
8. severe liver dysfunction
9. patients with obvious active malignant tumor
10. women suspected of pregnancy or pregnant
11. patients with a history of use SGLT2 inhibitors
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKAHIRO YAMAGISHI |
Organization
Kitasato University School of Medicine
Division name
Endocrinology and Metabolism
Zip code
Address
1-15-1,kitasato,minami-ku,sagamihara-city,kanagawa-ken,JAPAN
TEL
042-778-8111
yamagishi@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKAHIRO YAMAGISHI |
Organization
Kitasato University School of Medicine
Division name
Endocrinology and Metabolism
Zip code
Address
1-15-1,kitasato,minami-ku,sagamihara-city,kanagawa-ken,JAPAN
TEL
042-778-8111
Homepage URL
yamagishi@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine,Endocrinology and Metabolism.
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
北里大学病院（神奈川県）
Kitasato University Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 04 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 19 | 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 | 09 | Month | 04 | Day |
Last modified on
| 2017 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017514
