UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061139 |
|---|---|
| Receipt number | R000069893 |
| Scientific Title | Long-term effects of imeglimin on glycemic control, endogenous insulin secretion, and treatment intensity in patients with type 2 diabetes: a retrospective observational study |
| Date of disclosure of the study information | 2026/04/06 |
| Last modified on | 2026/04/02 16:05:44 |
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Basic information
Public title
Long-term metabolic profiles and treatment intensity during imeglimin therapy in patients with type 2 diabetes: a retrospective observational study
Acronym
LITE study
Scientific Title
Long-term effects of imeglimin on glycemic control, endogenous insulin secretion, and treatment intensity in patients with type 2 diabetes: a retrospective observational study
Scientific Title:Acronym
LITE study
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe long-term changes in glycemic control and endogenous insulin secretion in patients with type 2 diabetes receiving imeglimin in routine clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in HbA1c 12 months after starting imeglimin
Key secondary outcomes
Changes in glycated albumin (GA)
Changes in the GA/HbA1c ratio
Changes in the C-peptide index (CPI)
Changes in the Medication effect score (MES)
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
Patients with type 2 diabetes aged 20 or older who started imeglimin and continued treatment for 12 months or more.
Key exclusion criteria
Cases with type 1 diabetes, pregnant or breastfeeding women, patients with serious acute illnesses, and cases with insufficient follow-up data.
Target sample size
73
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Fujita |
Organization
Osaka General medical Center
Division name
Department of Diabetes and Endocrinology
Zip code
5588558
Address
Osaka Prefecture, Osaka City, Sumiyoshi Ward, Mandai Higashi 3-1-56
TEL
0666921201
fujita.yohei93@gmail.com
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Fujita |
Organization
Osaka General Medical Center
Division name
Department of Diabetes and Endocrinology
Zip code
5588558
Address
Osaka Prefecture, Osaka City, Sumiyoshi Ward, Mandai Higashi 3-1-56
TEL
0666921201
Homepage URL
fujita.yohei93@gmail.com
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Others
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
Osaka General Medical Center
Address
Osaka Prefecture, Osaka City, Sumiyoshi Ward, Mandai Higashi 3-1-56
Tel
0666921201
fujita.yohei93@gmail.com
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
| 2026 | Year | 04 | 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
73
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was a single-center retrospective observational study, analyzing treatment and laboratory data obtained under normal clinical practice. No new interventions or treatment instructions were given for research purposes.
Management information
Registered date
| 2026 | Year | 04 | Month | 02 | Day |
Last modified on
| 2026 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069893
