UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050228 |
|---|---|
| Receipt number | R000057140 |
| Scientific Title | Observational Study of the effect of SGLT2 inhibitor on Glycemic Control Indices |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/02/03 15:12:17 |
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Basic information
Public title
Observational Study of the effect of SGLT2 inhibitor on Glycemic Control Indices
Acronym
Observational Study of the effect of SGLT2 inhibitor on Glycemic Control Indices
Scientific Title
Observational Study of the effect of SGLT2 inhibitor on Glycemic Control Indices
Scientific Title:Acronym
Observational Study of the effect of SGLT2 inhibitor on Glycemic Control Indices
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of the glycemic control index appropriate for the patients taking SGLT2 inhibitor
Basic objectives2
Others
Basic objectives -Others
The effects on glycemic control indices by SGLT2 inhibitor
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of GA/HbA1c ratio between patients taking SGLT2 inhibitor and those not
Key secondary outcomes
Comparison of glycemic control indices between patients taking SGLT2 inhibitor and those not
Exploratory analysis of factors contributing to glycemic control indices
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
Patients who visited Nagoya university hospital or the joint research institute between April 17,2014 and December 31,2022
Those with the data both HbA1c and glycated albumin measured simultaneously
Those with the data both HbA1c and glucose management indicator measured simultaneously
Key exclusion criteria
None
Target sample size
4250
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Arima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
466-8560
Address
65 Tsurumai-Cho, Showa-Ku, Nagoya
TEL
052-744-2142
arima105@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Onoue |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
466-8560
Address
65 Tsurumai-Cho, Showa-Ku, Nagoya
TEL
052-744-2142
Homepage URL
t-onoue@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Institutional Review Board of the Ethics Committee of Nagoya University
Address
65 Tsurumai-Cho, Showa-Ku, Nagoya
Tel
052-741-2111
ethics@med.nagoya-u.ac.jp
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
| 2023 | Year | 04 | Month | 01 | 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
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We aim to clarify the SGLT2 inhibitor's effects on glycemic control indices by conducting a retrospective cohort study of patients with the data both HbA1c and other glycemic control indices measured simultaneously.
Management information
Registered date
| 2023 | Year | 02 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057140
