Unique ID issued by UMIN | UMIN000055030 |
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Receipt number | R000062868 |
Scientific Title | New Observational study on tofogliflozin as the MOst suitable approach to REcurrent urinary tract STONEs in patients with type 2 diabetes mellitus (NO MORE STONE trial) |
Date of disclosure of the study information | 2024/07/20 |
Last modified on | 2024/08/01 10:51:08 |
New Observational study on tofogliflozin as the MOst suitable approach to REcurrent urinary tract STONEs in patients with type 2 diabetes mellitus (NO MORE STONE trial)
Observational study on tofogliflozin to recurrent urinary tract stones in patients with type 2 diabetes mellitus (NO MORE STONE trial)
New Observational study on tofogliflozin as the MOst suitable approach to REcurrent urinary tract STONEs in patients with type 2 diabetes mellitus (NO MORE STONE trial)
New Observational study on tofogliflozin as the MOst suitable approach to REcurrent urinary tract STONEs in patients with type 2 diabetes mellitus (NO MORE STONE trial)
Japan |
Type 2 diabetic patients with a history of urinary tract stones
Endocrinology and Metabolism | Urology |
Others
NO
To evaluate the effect of tofogliflozin, an SGLT2 inhibitor, on recurrent urinary tract stones in type 2 diabetic patients with a history of urinary tract stones
Efficacy
Cumulative 96-week urinary tract stone recurrence rate
Observational
18 | years-old | <= |
Not applicable |
Male and Female
1.Patient has been diagnosed with type 2 diabetes mellitus.
2.Patient is scheduled to receive a new administration of tofogliflozin because the patient has failed to meet the glycemic control goals specified in the Diabetes Treatment Guide 2022-2023 despite treatment with diet and exercise therapy or treatment with diabetes medications in addition to diet and exercise therapy for at least 12 weeks.
3.Patient is at least 18 years of age at the time of consent.
4.Patient has urinary tract stones [excluding lower urinary tract stones (bladder stones and urethral stones)] within 5 years.
5.No urinary tract stones (no stones) on CT within 12 weeks prior to obtaining consent.
6.Written consent to participate in the research has been obtained from the individual.
1. Patients with a history of hypersensitivity to any component of tofogliflozin
2. Patients with a history of taking SGLT2 inhibitors within 12 weeks prior to obtaining consent
3. Patients with severe ketosis, diabetic coma or pre-coma
4. Patients with severe infection, perioperative, or severe trauma
5. Patients with type 1 diabetes mellitus
6. Patients with extremely poor glycemic control (HbA1c > 10%)
7. Pregnant, lactating, possibly pregnant or planning to become pregnant
8. Patients with malignant tumors or with a history of malignant tumors (except for patients who are not currently receiving treatment for malignant tumors and have no evidence of recurrence, and patients who can be judged not to have recurred during the study period)
9. Patients with end-stage renal failure (eGFR less than 15 mL/min/1.73m2)
10. Patients with a history of urinary tract and genital tract infection within 1 year
11. Patients who have been determined to be unsuitable as a subject by a physician
100
1st name | Go |
Middle name | |
Last name | Anan |
Yotsuya Medical Cube
Urology
1020084
7-7 Nibancho, Chiyoda-ku, Tokyo
03-3261-0401
g-anan@mcube.jp
1st name | Go |
Middle name | |
Last name | Anan |
Yotsuya Medical Cube
Urology
1020084
7-7 Nibancho, Chiyoda-ku, Tokyo
03-3261-0401
g-anan@mcube.jp
Clinical Research Management Department, Yotsuya Medical Cube
Kowa Company, Ltd.
Profit organization
Iida Clinic, Kitasaito Hospital
Clinical Research Management Department, Yotsuya Medical Cube
7-7 Nibancho, Chiyoda-ku, Tokyo
03-3261-0401
ymc_rinsyou@mcube.jp
NO
2024 | Year | 07 | Month | 20 | Day |
Unpublished
Open public recruiting
2024 | Year | 05 | Month | 24 | Day |
2024 | Year | 06 | Month | 11 | Day |
2024 | Year | 07 | Month | 22 | Day |
2027 | Year | 12 | Month | 31 | Day |
Patients will be started on tofogliflozin, an SGLT2 inhibitor, and will be monitored for recurrence of urinary tract stones at 4, 24, 48, and 96 weeks for blood sampling, urine analysis, CT scan and X-rays every 48 weeks, and physical findings (sudden back pain and hematuria) at each visit as in the usual medical practice.
2024 | Year | 07 | Month | 20 | Day |
2024 | Year | 08 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062868
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