UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057714 |
|---|---|
| Receipt number | R000065949 |
| Scientific Title | A retrospective, 12-month longitudinal cohort study of imeglimin 1,000 mg twice daily evaluating glycemic control, beta-cell function, and glycemic variability in Japanese patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2026/03/30 16:25:42 |
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Basic information
Public title
Long-term Effects of Imeglimin on Japanese Patients with Type 2 Diabetes Mellitus
Acronym
LITE study
Scientific Title
A retrospective, 12-month longitudinal cohort study of imeglimin 1,000 mg twice daily evaluating glycemic control, beta-cell function, and glycemic variability in Japanese patients with type 2 diabetes mellitus
Scientific Title:Acronym
LITE study
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus (T2DM)
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Type 2 diabetes mellitus is marked by a progressive loss of beta-cell function and increasing glycemic variability, both of which compromise long-term metabolic stability. Imeglimin, a first-in-class glimin, exerts dual actions by amplifying glucose-stimulated insulin secretion and enhancing insulin signaling in liver and muscle, but its real-world, long-term effects on beta-cell preservation and short-term glucose fluctuations remain unexplored. This retrospective, 12-month longitudinal cohort study (LITE Study) therefore aims to characterize the impact of imeglimin 1,000 mg twice daily on glycemic control, beta-cell function, and glycemic variability in Japanese adults with T2DM.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in hemoglobin A1c (HbA1c) from baseline to 52 weeks
Key secondary outcomes
Change in the glycated albumin to HbA1c ratio (GA/HbA1c) from baseline to 52 weeks
Change in C-peptide reactivity index (CPI) from baseline to 52 weeks
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
Age: Adults aged 20 years or older.
Diagnosis: Japanese patients with a confirmed diagnosis of type 2 diabetes mellitus (T2DM).
Start of treatment: Patients must start treatment with 1,000 mg of Imeglimin twice daily between June 1, 2021 and March 31, 2025.
Duration of treatment: Patients must continue using Imeglimin for at least 52 weeks (12 months) after starting treatment.
Data availability: Sufficient clinical and laboratory data required for primary analysis, such as HbA1c, GA, and C-peptide reactivity index (CPI) at baseline and each follow-up time (1, 3, 6, and 12 months), must be available.
Key exclusion criteria
Diagnosis of type 1 diabetes: Patients who have been clearly diagnosed with type 1 diabetes.
Pregnant or breastfeeding: Pregnant or breastfeeding women.
Renal impairment: Patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2.
Severe infection: Patients with a severe infection requiring treatment.
Pre- or post-operative condition: Patients in a state of acute physical stress, such as before or after surgery.
Data deficient: Patients for whom sufficient clinical and test data required for primary analysis cannot be obtained.
Target sample size
40
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
Nothing
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
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
| 2025 | Year | 05 | 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
37
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
Terminated
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 | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2025 | Year | 04 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065949
