Type 2 diabetic patients with a history of urinary tract stones
Conditions
Interventions
None listed
Sponsors
Clinical Research Management Department, Yotsuya Medical Cube
Iida Clinic, Urayasu Central Park Clinic, Kitasaito Hospital, Hattori Clinic No2, Togoshi Urology and Internal Medicine Clinic, Nagoya City University Graduate School of Medical Sciences, Hachinohe Heiwa Hospital, Harasanshin Hospital, Fujisawa Shonandai Hospital, Meirikai Tokyo Yamato Hospital, Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 requiring active treatment were identified on a CT scan performed within 12 weeks prior to obtaining informed consent. 6.Written consent to participate in the research has been obtained from the individual.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative 96-week urinary tract stone recurrence rate | — |
Countries
Japan
Contacts
Public ContactGo Anan
Yotsuya Medical Cube Urology
Outcome results
None listed