UMIN-CTR Clinical Trial

Basic information
Public title	Effects of imeglimin in patients with type 2 diabetes mellitus
Acronym	Effects of imeglimin in patients with type 2 diabetes mellitus
Scientific Title	Effects of imeglimin in patients with type 2 diabetes mellitus
Scientific Title:Acronym	Effects of imeglimin in patients with type 2 diabetes mellitus
Region	Japan

Condition
Condition	type 2 diabetes mellitus
Classification by specialty	Medicine in general Endocrinology and Metabolism Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the effect of imeglimin on various parameters in patients with type 2 diabetes mellitus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose and skeletal muscle related parameters
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with type 2 diabetes attending the Department of Diabetes and Metabolism HbA1c between 7.0% and 10%. Patients with written consent
Key exclusion criteria	Patients with a history of severe ketoacidosis, diabetic coma, or pre-coma Patients with malignant tumors and other serious diseases with poor prognosis Impaired renal function: eGFR <45 mL/min/1.73 m2
Target sample size	30

Research contact person
Name of lead principal investigator	1st name satoshi Middle name Last name ida
Organization	Ise Red Cross Hospital
Division name	Department of diabetes and metabolism
Zip code	516-8512
Address	1-471-2, Funae, 1-chome
TEL	0596282171
Email	bboy98762006@yahoo.co.jp

Public contact
Name of contact person	1st name satoshi Middle name Last name ida
Organization	Ise Red Cross Hospital
Division name	Department of diabetes and metabolism
Zip code	516-8512
Address	1-471-2, Funae, 1-chome
TEL	0596282171
Homepage URL
Email	bboy98762006@yahoo.co.jp

Sponsor
Institute	Ise Red Cross Hospital
Institute
Department

Funding Source
Organization	Ise Red Cross Hospital
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 of Ise Red Cross Hospital
Address	1-471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
Tel	0596282171
Email	bboy98762006@yahoo.co.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	2022 Year 10 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
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	Preinitiation
Date of protocol fixation	2022 Year 10 Month 01 Day
Date of IRB	2022 Year 09 Month 30 Day
Anticipated trial start date	2022 Year 10 Month 01 Day
Last follow-up date	2023 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2022 Year 09 Month 30 Day
Last modified on	2022 Year 09 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055907