UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045345 |
|---|---|
| Receipt number | R000051744 |
| Scientific Title | Study to evaluate intestinal glucose excretion using 18F-FDG-PET/MR enterography in patients taking imeglimin |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/09/03 14:14:46 |
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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
Assess intestinal glucose excretion by imaging 18F-FDG-PET/MRenterography (PET/MRE) in type 2 diabetic patients who are taking imeglimin.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FDG excretion into the intestine per hour
Key secondary outcomes
Clinical parameters of blood biochemical test items such as HbA1c and blood glucose levels, and background factors of the research subjects (height, weight, gender, duration of diabetes, etc.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
PET/MRI scan in patients with imeglimin
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
1. type 2 diabetic patients
2. patients who have taken imeglimin 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 who have not taken metformin for more than 1 month at the time of consent and are not expected to take metformin until the date of PET/MRE examination
4. patients with no obvious lesions in the lower gastrointestinal tract
5. patients who are 20 years old or older at the time of consent
6. 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 theinvestigator
Target sample size
5
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
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
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
undecided
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
Intervention research ethics review committee of Kobe University Hospital
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
Tel
0783826669
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
| 2021 | 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
| 2021 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 09 | Month | 02 | Day |
Last modified on
| 2021 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051744
