type 2 diabetes
Conditions
Interventions
The luseogliflozin group: Administer luseogliflozin 2.5 mg a day orally. Administration of luseogliflozin is increased to 5.0 mg if participants cannot achieve the HbA1c levels less than 7.0 % at ea
Sponsors
Nagasaki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Selection criteria at enrollment into the study (1) Outpatient (2) Patient treated with diet therapy alone or with oral anti-diabetic agents including metformin (less than or equal to 1000 mg per day) or/and alpha-glucosidase inhibitors or/and DPP4 inhibitors. The treatment of oral anti-diabetic agents is needed to be not changed within 6 months before enrolled. Patients who have previously treated any anti-diabetic agents excluding metformin, alpha-glucosidase inhibitors, or DPP4 inhibitors can be participated in this study if the treatment was discontinued more than 6 months before enrolled into the study. (3) Written informed consent 2. Selection criteria at the start of the study (4) HbA1c level at more than or equal to 7%, and less than 9%. (5) T-scores of bone mineral density of both lumbar vertebrae and proximal part of femur are over -2.5 S.D. determined by dual energy X-ray absorptiometry.
Exclusion criteria
Exclusion criteria: (1) Previous history of treatment with SGLT2 inhibitors (2) Complicated with bone metabolic disorders including osteomalacia, thyroid dysfunction, hyperparathyroidism or hypoparathyroidism that require any medical treatments (3) Administered any treatments for osteoporosis described below at present or within the past 12 months before enrolled into the study; bisphosphonate, vitamin D preparation, vitamin K preparation, calcium preparation, selective estrogen receptor modulator (SERM), anti-RANKL antibody (denosumab), anti-sclerostin antibody (romosozumab) or parathyroid hormone (teriparatide) (4) Treated with estrogen or testosterone (5) Complicated with diabetic retinopathy or/and diabetic neuropathy requiring therapeutic intervention (6) Sever renal dysfunction with eGFR <30 ml/min/1.73 m2 (7) Anemia with hemoglobin level under 10 g/dL (8) Complicated with malignancy (9) Hypersensitivity or allergy to the study drugs including luseogliflozin or metformin (10) Taking alcohol more than 20 g/day (11) Smoking cigarette within one year before enrolled into the study (12) Participated in other clinical trials within 6 months before enrolled into the study (13) Complicated with chronic liver disease with Child-Pugh score of more than or equal to 6 points. (14) BMI <18.5 kg/m2 (15) Judged as an unsuitable participant by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the predicted bone strength of radius and tibia calculated using HR-pQCT (kN/mm) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the values of blood and biochemical tests. Changes in the bone mineral density at lumbar spine, femur, radius measured by dual-energy X-ray absorptiometry. Incidence of vertebral fracture or femoral fracture. Changes in the values of bone metabolic markers. Changes in the values related with cortical bone structure, travecular bone structure or bone morphology calculated using by HR-pQCT. | — |
Countries
Japan
Contacts
Public ContactIchiro Horie
Nagasaki University Hospital Endocrinology and Metabolism
Outcome results
None listed