UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046316
Receipt number R000052856
Scientific Title A Prospective Observational Study of clinical use of Imeglimin for type 2 diabetes mellitus
Date of disclosure of the study information 2021/12/10
Last modified on 2023/06/10 19:09:08

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Basic information

Public title

A Prospective Observational Study of clinical use of Imeglimin for type 2 diabetes mellitus

Acronym

A Prospective Observational Study of clinical use of Imeglimin for type 2 diabetes mellitus

Scientific Title

A Prospective Observational Study of clinical use of Imeglimin for type 2 diabetes mellitus

Scientific Title:Acronym

A Prospective Observational Study of clinical use of Imeglimin for type 2 diabetes mellitus

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clinical safety and efficacy of imeglimin

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HbA1c in 3 months after imeglimin initiation

Key secondary outcomes



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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Subjects who is clinically planned to start imeglimin treatment.
1) Clinically diagnosed type 2 diabetes mellitus
2) Age >= 20 years old
3) Written informed consent
4) HbA1c < 10.5%, eGFR >=45 mL/min/1.73m2

Key exclusion criteria

1) Allergy against imeglimin
2) Severe ketosis, coma, type 1 diabetes
3) Severe infection, surgery, injury
4) eGFR < 45 mL/min/1.73m2
5) Severe liver dysfunction (Child-Pugh C)
6) Subjects with pregnancy or lactation
7) Use of Insulin
8) Others who medical doctors judge as inappropriate subjects for imeglimin use.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Nobuya
Middle name
Last name Inagaki

Organization

Kyoto University Hospital

Division name

Department of Diabetes, Endocrinology, and Nutrition

Zip code

606-8507

Address

54 Kawahara-cho SHogoin SAkyo-ku, Kyoto City

TEL

075-751-3560

Email

inagaki@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Takaaki
Middle name
Last name Murakami

Organization

Kyoto University Hospital

Division name

Department of Diabetes, Endocrinology, and Nutrition

Zip code

606-8507

Address

54 Kawahara-cho SHogoin SAkyo-ku, Kyoto City

TEL

075-751-3560

Homepage URL


Email

tmurakam@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital
Department of Diabetes, Endocrinology, and Nutrition

Institute

Department

Personal name



Funding Source

Organization

Kyoto University

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

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-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



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 12 Month 10 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

Completed

Date of protocol fixation

2021 Year 12 Month 10 Day

Date of IRB

2022 Year 01 Month 06 Day

Anticipated trial start date

2022 Year 02 Month 01 Day

Last follow-up date

2023 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a prospective observational study. In daily clinical setting, The subjects with type 2 diabetes who is planned to start imeglimin treatment are enrolled and their datas on electronic health record are used for the analysis.


Management information

Registered date

2021 Year 12 Month 08 Day

Last modified on

2023 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052856


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name