Clinical study to investigate whether tofogliflozin increased plasma magnesium level regulates sympathetic tone in type 2 diabetes

Clinical study to investigate whether tofogliflozin increased plasma magnesium level regulates sympathetic tone in type 2 diabetes - COMT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048055

Enrollment

Registered

2022-06-14

Start date

2022-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Changes in serum magnesium concentration during the study period	—

Countries

Japan

Contacts

Public ContactEmi Kawakita

Shimane University Faculty of Medicine Internal Medicine 1

kawakita@med.shimane-u.ac.jp0853-20-2183

Outcome results