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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000048055 |
Receipt No. | 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 | 2022/06/14 |
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 |
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Condition | ||
Condition | Type 2 diabetes | |
Classification by specialty |
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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 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
Other related information | Study design: Multi-institutional prospective observational study
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Management information | |||||||
Registered date |
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Last modified on |
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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 |