UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015759 |
|---|---|
| Receipt number | R000018335 |
| Scientific Title | Effect of SGLT2 inhibitor on lactic acid,ketone bodies,glucagon in type 2 diabetes mellitus patients. |
| Date of disclosure of the study information | 2014/12/16 |
| Last modified on | 2014/11/26 14:43:09 |
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Basic information
Public title
Effect of SGLT2 inhibitor on lactic acid,ketone bodies,glucagon in type 2 diabetes mellitus patients.
Acronym
Effect of SGLT2 inhibitor on lactic acid,ketone bodies,glucagon in type 2 diabetes mellitus patients.
Scientific Title
Effect of SGLT2 inhibitor on lactic acid,ketone bodies,glucagon in type 2 diabetes mellitus patients.
Scientific Title:Acronym
Effect of SGLT2 inhibitor on lactic acid,ketone bodies,glucagon in type 2 diabetes mellitus patients.
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate change of glucose,lactic acid,ketone bodies, and glucagonin type 2 diabetes mellitus by SGLT2 inhibitor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of serum lactic acid, ketone bodies,CPR,and glucagon value comparing with baseline.
Key secondary outcomes
Comparing with baseline change of urinalysis (sodium, potassium, glucose,osmotic pressure),uric acid,PRA,PAC,ACTH,cortisol,AVP,osmotic pressure.
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 inhibitor
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)age 20 to less than 90.
2)ongoing treatment by sulfonylurea, biguanide, DPP4 inhibitor, thiazolidine, or insulin therapy.
Key exclusion criteria
1)Type 1 diabetes mellitus.
2) having diabetic ketoacidosis, nonketotic hyperosmolar coma, infection.
3) being pregnant or possibly pregnant.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Takeda |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Endoclinology
Zip code
Address
1-1 yanagido, gifu, japan
TEL
058-230-6523
kh0123789@outlook.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Hashimoto |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Endoclinology
Zip code
Address
1-1 yanagido, gifu, japan
TEL
058-230-6523
Homepage URL
kh0123789@outlook.jp
Sponsor or person
Institute
Department of Endoclinology, Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Endoclinology, Gifu University Graduate School of Medicine
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 | 12 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 26 | 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 | 11 | Month | 26 | Day |
Last modified on
| 2014 | 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=R000018335
