Type 2 Diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Nagasaki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be included: 1.Age: Patients with type 2 diabetes mellitus who are 40 years or older at the time of consent. 2.Sex: No restriction. 3.Inpatient/Outpatient Status: No restriction. 4.Glycemic Control: Patients with inadequate glycemic control (HbA1c >= 7.0%) or those with HbA1c >= 6.0% for whom the attending physician considers treatment with an SGLT2 inhibitor appropriate. 5.Prior SGLT2 Inhibitor Use: Patients who have not taken an SGLT2 inhibitor within the past six months. 6.Informed Consent: Patients who have received a sufficient explanation of the study, fully understood it, and provided written consent of their own free will.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1.Implantable Medical Devices: Patients using implantable medical devices such as a cardiac pacemaker. 2.Bone Metabolic Disorders: Patients with bone metabolic diseases requiring therapeutic intervention, including osteomalacia, thyroid dysfunction, hyperparathyroidism, and hypoparathyroidism. 3.Osteoporosis Treatment: Patients who have newly started any of the following osteoporosis treatments within six months prior to obtaining consent or those who are expected to discontinue any of the following treatments between consent acquisition and the end of the study: Bisphosphonates, Vitamin D preparations Vitamin K preparations, Calcium preparations, Selective estrogen receptor modulators (SERMs), Anti-RANKL antibody (denosumab), Anti-sclerostin antibody (romosozumab), Parathyroid hormone preparations (teriparatide, abaloparatide) 4.Severe Renal Impairment: Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2). 5.Active Malignancy: Patients with an active malignant tumor. 6.Participation in Other Trials: Patients who have participated in other clinical trials or research involving investigational drugs or medical devices within six months prior to obtaining consent. 7.Severe Underweight: Patients with severe underweight (BMI < 18.5 kg/m2). 8.Other Conditions: Patients deemed inappropriate for the study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in estimated bone strength of the radius and tibia calculated by HR-pQCT from the start of tofogliflozin administration to week 48 of treatment. | — |
Countries
Japan
Contacts
Public ContactAi Haraguchi
Nagasaki University Hospital Endocrinology and Metabolism
Outcome results
None listed