UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058230
Receipt number R000066574
Scientific Title Retrospective Study on the Effect of Imeglimin in Patients with Type 2 Diabetes Mellitus Complicated by Metabolic Dysfunction-Associated Steatotic Liver Disease
Date of disclosure of the study information 2025/06/20
Last modified on 2025/06/20 10:04:36

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Basic information

Public title

Retrospective study examining the impact of imeglimine on patients with type 2 diabetes mellitus complicated by MASLD.

Acronym

Imeglimin in MASLD patients with type 2 diabetes

Scientific Title

Retrospective Study on the Effect of Imeglimin in Patients with Type 2 Diabetes Mellitus Complicated by Metabolic Dysfunction-Associated Steatotic Liver Disease

Scientific Title:Acronym

IME-MASLD: Imeglimin's Effect in Type 2 Diabetes Patients with MASLD - A Retrospective Study

Region

Japan


Condition

Condition

metabolic dysfunction associated steatotic liver disease
type 2 diabetes

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the clinical course of patients with type 2 diabetes mellitus complicated by MASLD who are on regular hospital attendance, with and without imeglimine, and to assess its impact on glucose tolerance and MASLD.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in HbA1c with and without imeglimine use in type 2 diabetes patients with MASLD.

Key secondary outcomes

Glucose tolerance related (GA, blood glucose, urinary albumin-creatinine ratio, blood C-peptide), fatty liver MASLD related (BMI, AST, ALT, G-GTP, ALP, T-Bil, ALB, PT, Total Cholesterol, TG, HDL Cholesterol, LDL Cholesterol, BUN, Cr, eGFR, Plt, Fib4 index, type 4 collagen 7S, autotaxin, M2BPGi, APRI, VCTE from fibroscan, CAP, FAST Score values, AGE, various InBody Changes in laboratory values (body weight, muscle mass, body fat percentage, extracellular water ratio)


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with type 2 diabetes mellitus complicated by fatty liver/MASLD who attended an eligible medical institution during the period under study, with and without imeglimine use.
2) Patients for whom the required data collection items (see below) are recorded in the electronic medical record.

Key exclusion criteria

1) Patients for whom the required data items cannot be collected in the medical record

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Kensaku
Middle name
Last name Fukunaga

Organization

Kagawa University,

Division name

Department of Endocrinology and Metabolism, Faculty of Medicine,

Zip code

761-0793

Address

1750-1, Ikenobe, Miki-cho, Kita-gun

TEL

0878912230

Email

fukunaga.kensaku@kagawa-u.ac.jp


Public contact

Name of contact person

1st name kensaku
Middle name
Last name fukunaga

Organization

Kagawa university

Division name

Department of Endocrinology and Metabolism

Zip code

761-0793

Address

1750-1, Ikenobe, Miki-cho, Kita-gun

TEL

0878912230

Homepage URL


Email

fukunaga.kensaku@kagawa-u.ac.jp


Sponsor or person

Institute

Kagawa university

Institute

Department

Personal name

Fukunaga


Funding Source

Organization

none

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

Ethics Committee, Faculty of Medicine, Kagawa University

Address

1750-1, Miki-cho

Tel

0878985111

Email

chiken-m@kagawa-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

--- Select One ---


Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2025 Year 06 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

80

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

Completed

Date of protocol fixation

2024 Year 12 Month 20 Day

Date of IRB

2024 Year 12 Month 20 Day

Anticipated trial start date

2024 Year 12 Month 20 Day

Last follow-up date

2024 Year 12 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

ver.3


Management information

Registered date

2025 Year 06 Month 20 Day

Last modified on

2025 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066574