UMIN-CTR Clinical Trial

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
Email	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
Email	kawakita@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Faculty of Medicine
Institute
Department

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
Email	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	Preinitiation
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	2022 Year 06 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054766

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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