UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032848 |
|---|---|
| Receipt number | R000035928 |
| Scientific Title | Study on indicators for predicting the therapeutic effect of SGLT2 inhibitors under actual clinical practice in T2DM patients |
| Date of disclosure of the study information | 2018/06/03 |
| Last modified on | 2023/12/06 09:17:44 |
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Basic information
Public title
Study on indicators for predicting the therapeutic effect of SGLT2 inhibitors under actual clinical practice in T2DM patients
Acronym
Study on indicators for predicting therapeutic effect of SGLT2 inhibitors.
Scientific Title
Study on indicators for predicting the therapeutic effect of SGLT2 inhibitors under actual clinical practice in T2DM patients
Scientific Title:Acronym
Study on indicators for predicting therapeutic effect of SGLT2 inhibitors.
Region
| Japan |
Condition
Condition
type 2 diabetes mellituds
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Explore the indictors for predicting the effect of SGLT2 inhibitors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Improvement of HbA1c
decrese of Body Weight
Key secondary outcomes
Improvement of liver function
Improvement of fatty liver
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese T2DM patients who started SGLT2 inhibitor and received regular ambulatory treatment in Osaki Citizen Hospital Division of Endocrinology and Diabetes between May 2015 and April 2017
Key exclusion criteria
1) Anti-glutamic acid decarboxylase (GAD) antibody above normal range.
2) HBs antigen or/end HCV antibody is positive.
3)Patients who discontinue the use of SGLT2 inhibitors during the period.
4)Patients who were taking acarbose and/or herbal medicines.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Usui |
Organization
Osaki Citizen Hospital
Division name
Division of Metabolism and Diabetes
Zip code
Address
3-8-1 Furukawahonami,Osaki ,Miyagi
TEL
0229-23-3311
masausui@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Usui |
Organization
Osaki Citizen Hospital
Division name
Division of Metabolism and Diabetes
Zip code
Address
3-8-1 Furukawahonami,Osaki ,Miyagi
TEL
0229-23-3311
Homepage URL
masausui@med.tohoku.ac.jp
Sponsor or person
Institute
Osaki Citizen Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2018 | Year | 06 | Month | 03 | 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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Divide patients into HbA1c-improved group and non-improved group and examine clinical indicators with significant difference between the groups.
Management information
Registered date
| 2018 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035928
| 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 |
