UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059559 |
|---|---|
| Receipt number | R000068066 |
| Scientific Title | Observational study for the frequency of nocturnal hypoglycemia with switching SGLT2 inhibitors. |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/28 00:29:14 |
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Basic information
Public title
Observational study for the frequency of nocturnal hypoglycemia with switching SGLT2 inhibitors.
Acronym
Nocturnal hypoglycemia with switching SGLT2 inhibitors.
Scientific Title
Observational study for the frequency of nocturnal hypoglycemia with switching SGLT2 inhibitors.
Scientific Title:Acronym
Nocturnal hypoglycemia with switching 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
Evaluating hypoglycemic events using continuous glucose monitoring (CGM) before and after switching SGLT2 inhibitors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The absolute and relative changes in nocturnal Time Below Range (TBR, <70 mg/dL) before and after switching SGLT2 inhibitors.
Key secondary outcomes
Changes and change rates in nocturnal TIR (Time in Range, 70-180 mg/dL) and TAR (Time Above Range, >180 mg/dL)
Changes and change rates in daily TBR, TIR, and TAR
Changes and change rates in daytime TBR, TIR, and TAR
Changes and change rates in mean glucose, GMI (Glucose Management Indicator), and glycemic variability
Duration of hypoglycemia
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 years or older at the time of the agreement
2) Within two to ten-weeks period after switching SGLT2 inhibitors.
3) Obtaining written consent for the participation in this study
Key exclusion criteria
1) Changing the diabetic medicine except SGLT2 inhibitor after the hypoglycemia confirmation of the former SGLT2 inhibitor
2) Judging to be inappropriate for study entry from medical grounds by physicians
3) Not obtaining written consent for the participation in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Ishigaki |
Organization
Iwate Medical University
Division name
Divisions of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
028-3694
Address
1-1-1 Idai-dori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
+81-19-651-5111
ishigaki@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyasu |
| Middle name | |
| Last name | Oda |
Organization
Iwate Medical University
Division name
Divisions of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
028-3694
Address
1-1-1 Idai-dori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
+81-19-651-5111
Homepage URL
toda@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical University
Address
1-1-1 Idai-dori, Yahaba-cho, Shiwa-gun, Iwate, Japan
Tel
+81-19-651-5111
kenkyu-rinri@j.iwate-med.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
| 2025 | Year | 11 | 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
| 2025 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No Important Notice
Management information
Registered date
| 2025 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068066
