ongitudinal analysis of bone microstructural changes under luseogliflozin treatment using second-generation High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) in elderly patients with type 2 diabetes - Bone microstructural changes under luseogliflozin treatment

Horie Ichiro0 个研究点目标入组 22 人开始时间: 2019年3月19日最近更新: 2023年10月17日

试验速览

o adverse effectes on bone microarchitecture were observed by 48 weeks treatment with luseogliflozin in patients with type 2 diabetes.

•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.

•(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 K2 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.

发起方

Horie Ichiro