UMIN-CTR Clinical Trial

Basic information
Public title	Study to evaluate intestinal glucose excretion using 18F-FDG-PET/MR Enterography in patients taking imeglimin
Acronym	Imeglimin PET/MRE study with imeglimin
Scientific Title	Study to evaluate intestinal glucose excretion using 18F-FDG-PET/MR Enterography in patients taking imeglimin
Scientific Title:Acronym	PET/MRE study with imeglimin
Region	Japan

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

Objectives
Narrative objectives1	Imeglimin, which has a similar chemical structure to metformin, reveals whether or not glucose excretion into the intestinal tract, comparable to metformin.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FDG excretion into the intestinal tract by 18F-FDG-PET/MRE
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	PET/MRE scan in patients with imeglimin
Interventions/Control_2	PET/MRI scan in patients with imeglimin and metformin
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. type 2 diabetic patients 2. patients who have taken imeglimin or imeglimin and metformin for more than 1 month at the time of consent and are expected to take imeglimin until the date of PET/MRE examination 3. patients with no obvious lesions in the lower gastrointestinal tract 4. patients who are 20 years old or older at the time of consent 5. patients who have obtained written consent from the patient
Key exclusion criteria	1. patients with the following contraindications to Buscopan (butyl scopolamine bromide) patients with hemorrhagic colitis patients with angle-closure glaucoma patients with dysuria due to prostatic hypertrophy patients with severe heart disease patients with anesthetic ileus patients with a history of hypersensitivity to this drug 2. patients with dementia or psychiatric disorders 3. patients with possible intestinal perforation or obstruction 4. patients with metals in the body that cannot be tested by PET/MRE 5. pregnant or lactating patients 6. other patients who are judged unsuitable for this study by the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Kazuhiko Middle name Last name Sakaguchi
Organization	Kobe University
Division name	Department of Diabetes and Endocrinology
Zip code	650-0017
Address	7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
TEL	078-382-5861
Email	kzhkskgc@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Kazuhiko Middle name Last name Sakaguchi
Organization	Kobe University
Division name	Department of Diabetes and Endocrinology
Zip code	650-0017
Address	7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
TEL	078-382-5861
Homepage URL
Email	kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Intervention research ethics review committee of Kobe University Hospital
Address	7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
Tel	0783826669
Email	kainyu@med.kobe-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	2022 Year 12 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 11 Month 02 Day
Date of IRB
Anticipated trial start date	2022 Year 12 Month 25 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 11 Month 04 Day
Last modified on	2022 Year 11 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056262