UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048055 |
|---|---|
| Receipt number | R000054766 |
| Scientific Title | Clinical study to investigate whether tofogliflozin increased plasma magnesium level regulates sympathetic tone in type 2 diabetes |
| Date of disclosure of the study information | 2022/06/14 |
| Last modified on | 2023/12/20 12:41:47 |
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Basic information
Public title
Clinical study to investigate whether tofogliflozin increased plasma magnesium level regulates sympathetic tone in type 2 diabetes
Acronym
COMT study
Scientific Title
Clinical study to investigate whether tofogliflozin increased plasma magnesium level regulates sympathetic tone in type 2 diabetes
Scientific Title:Acronym
COMT study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of tofogliflozin on serum magnesium level in type 2 diabetes patients.
Basic objectives2
Others
Basic objectives -Others
To investigate whether tofogliflozin increased serum magnesium level regulates sympathetic tone in type 2 diabetes patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum magnesium concentration during the study period
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Only those patients who meet all of the following criteria are included:
1. Patients with type 2 diabetes(T2D)
2. T2D patients with poor glycemic control and unable to achieve the blood glucose level stated in the Diabetes Treatment Guideline of 2020-2021, even though they are on drugs except SGLT2i with diet and physical therapy, or on diet and physical therapy only, for at least 12 weeks.
3. Patients without any change on their medication including antidiabetic drugs, or without taking therapeutic agent for at least 12 weeks before signing their consent form.
4. Patients aged 20 to 80 at the time of giving their consent
5. Patients who meet all of the following data:
1) serum magnesium under 1.8 mg/dL
2) eGFR 30 to 90 mL/min/1.73 m2
6. Patient who are able to provide their consent form
Key exclusion criteria
Those patients who meet one of the following criteria are excluded:
1. Patients with type 1 diabetes, or secondary diabetes
2. Patients with poor blood glucose control (HbA1c 10% or above)
3. Patients who are taking the medication with magnesium (including Mg supplement)
4. Patients who are taking loop diuretic or thiazide diuretic agents
5. Patients with serious liver functional impairment (AST:100 or above)
6. Patients with moderate to severe heart failure (class 3 or worse based on the New York Heart Association (NYHA)Functional Classification)
7. Patients with urinary tract infection, or genital infection
8. Patients who are pregnant, possibly pregnant, nursing, or planning to conceive a child
9. Patients with a malignant tumor or have a history of malignant tumor (exceptions: those are not on medication for malignant tumor, and have no recurrence of the disease so far and without recurrence risks during this study are allowed to participate)
10. Patients who are prohibited to use tofogliflozin
11. Other patients determined ineligible by an investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keizo |
| Middle name | |
| Last name | Kanasaki |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine 1
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2183
kkanasak@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | Kawakita |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine 1
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2183
Homepage URL
kawakita@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University
Name of secondary funder(s)
Kowa Company, Ltd.
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-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
島根大学医学部内科学講座内科学第一（島根県）、順天堂大学大学院医学研究科代謝内分泌内科学講座（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Multi-institutional prospective observational study
Management information
Registered date
| 2022 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054766
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