UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058702 |
|---|---|
| Receipt number | R000067117 |
| Scientific Title | Effects of antidiabetic drugs on endogenous insulin secretion in non-insulin-dependent type 1 diabetes mellitus |
| Date of disclosure of the study information | 2025/08/06 |
| Last modified on | 2025/08/05 17:48:07 |
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Basic information
Public title
Effects of antidiabetic drugs on endogenous insulin secretion in non-insulin-dependent type 1 diabetes mellitus
Acronym
Effects of antidiabetic drugs on endogenous insulin secretion in non-insulin-dependent type 1 diabetes mellitus
Scientific Title
Effects of antidiabetic drugs on endogenous insulin secretion in non-insulin-dependent type 1 diabetes mellitus
Scientific Title:Acronym
Effects of antidiabetic drugs on endogenous insulin secretion in non-insulin-dependent type 1 diabetes mellitus
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will identify a population of people who were initially diagnosed with type 2 diabetes and later re-diagnosed with type 1 diabetes, a group presumed to include individuals with features of slowly progressive type 1 diabetes (SPIDDM). The impact of diabetes medications on the trajectory of endogenous insulin secretion will then be examined in this cohort using real world data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
The number of days from when the disease "type 2 diabetes" was diagnosed to when the disease "type 1 diabetes" was diagnosed (evaluated by whether or not SGLT2 inhibitors were introduced during that period)
Key secondary outcomes
The number of days from when the disease "type 2 diabetes" was diagnosed to when the disease "type 1 diabetes" was diagnosed (evaluated by whether or not SU, DPP-4i, and GLP-1RA were introduced during that period)
Base
Study type
Others,meta-analysis etc
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
People who were initially diagnosed with type 2 diabetes (ICD-10 code: E12) and treated with antidiabetic drugs, and then diagnosed with type 1 diabetes (ICD-10 code: E10) between 90 days and less than 10 years after their type 2 diabetes diagnosis and in whom treatment with insulin preparations was initiated
Key exclusion criteria
1.People who developed diabetic ketoacidosis (E101 and E141) or were hospitalized within one month before or after the diagnosis of type 1 diabetes
2.The prescription of both long-acting and rapid-acting or ultra-rapid-acting insulin preparations prior to the diagnosis of type 1 diabetes had already been used.
3.The initiation of SGLT2i treatment followed the diagnosis of type 1 diabetes.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Seki |
Organization
The University of Tokyo Hospital
Division name
Department of Healthcare Information Management
Zip code
113-8655
Address
7-3-1, hongo, bunkyo-ku, Tokyo
TEL
03-3815-5411
seki@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | KYUYONG |
| Middle name | |
| Last name | CHO |
Organization
Hokkaido University Hospital
Division name
Institute of Health Science Innovation for Medical Care
Zip code
060-8648
Address
N14W5, kita-ku, Sapporo, Hokkaido
TEL
011-706-1161
Homepage URL
kyuyong-cho@pop.med.hokudai.ac.jp
Sponsor or person
Institute
The University of Tokyo
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
IRB-A, The University of Tokyo, Graduate School of Medicine / Faculty of Medicine Institutional Review Board
Address
7-3-1, hongo, bunkyo-ku, Tokyo
Tel
03-3815-5411
kyuyong-cho@pop.med.hokudai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025112NI
Org. issuing International ID_1
IRB-A, The University of Tokyo, Graduate School of Medicine / Faculty of Medicine Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Hokkaido
Institutions
Institutions
東京大学医学部附属病院、北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067117
