UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019429 |
|---|---|
| Receipt number | R000022472 |
| Scientific Title | Effect of blood sugar circadian variation using the CGM of SGLT2 inhibitors in patients with type 2 diabetes |
| Date of disclosure of the study information | 2015/10/20 |
| Last modified on | 2017/04/24 14:47:14 |
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Basic information
Public title
Effect of blood sugar circadian variation using the CGM of SGLT2 inhibitors in patients with type 2 diabetes
Acronym
Effect of blood sugar circadian variation of SGLT2 inhibitors in patients with type 2 diabetes
Scientific Title
Effect of blood sugar circadian variation using the CGM of SGLT2 inhibitors in patients with type 2 diabetes
Scientific Title:Acronym
Effect of blood sugar circadian variation of SGLT2 inhibitors in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Impact on blood sugar circadian variation using the CGM of SGLT2 inhibitors in patients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
blood sugar circadian variation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SGLT2 inhibitors
Interventions/Control_2
CGM
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
HbA1c 7.5% over Type 2 diabetes
Key exclusion criteria
Type 1 diabetes
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yoshimasa aso |
Organization
Dokkyo Medical University
Division name
Endocrinology and Metabolism
Zip code
Address
Mibu,Shimotsuga-gun,Tochigi 321-0293, Japan
TEL
0282-87-2150
yaso@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | mihoko matsumura |
Organization
Dokkyo Medical University
Division name
Endocrinology and Metabolism
Zip code
Address
Shimotsuga-gun,Tochigi 321-0293, Japan
TEL
0282-87-2150
Homepage URL
mimihoko@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Department of Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Myself
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 28 | 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 | 10 | Month | 20 | Day |
Last modified on
| 2017 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022472
