KCT0005710尚未招募未知
A multicenter randomized exploratory clinical trial to evaluate the effect of bone metabolism and the efficacy of evogliptin and dapagliflozin for blood sugar in the menopause female patients with osteopenia and type 2 diabetes.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 40(Year) 至 70(Year)（—）
- 性别
- Female
入选标准
- •1) Postmenopausal women between 40 and 70 years of age with type 2 diabetes patients who are not taking diabetes drugs or who are not controlled by blood sugar at 7.0%= HbA1c < 9.0% while taking metformin
- •? Menopause corresponds when one or more of the following three conditions are satisfied.
- •? 12 months of amenorrhea
- •? In the case of FSH=40 mIU/mL in women over 50 years who have undergone hysterectomy or 6 months of amenorrhea
- •? Patients 6 weeks after ovariectomy
- •2) Lumbar, neck of femur and total femur bone density measurements were -2.4=T-score<-1.0
- •3) Obtained written informed consent from a patient
- •4) Patients who can participate during clinical trials and perform all planned trial procedures and visits.
排除标准
- •1) A person who has taken a diabetes medications other than metformin within 12 weeks, or who is hypersensitivity to DPP4 inhibitors or SGLT2 inhibitors.
- •2) AST or ALT exceeds 2 times the upper limit of the normal range in laboratory tests
- •3) Patients with moderate or severe renal impairment, end-stage renal disease (ESRD) or dialysis
- •4) Patients whose eGFR (using MDRD formula) calculated using serum creatinine results within 4 weeks before screening or at screening is less than 60 mL/minute/1.73 m2
- •5) In case of osteoporosis medication dosage as follows:
- •- Patients who have ever used bisphosphonate formulations
- •- Patients who have used female hormones, SERM, denosumab, and parathyroid hormone preparations within 12 months
- •6) Have bone or mineral metabolic diseases or have received treatment that affects them
- •- Oral steroid 2.5mg or more has been continuously taken for more than 3 months from the date of consent
- •- Continuous use of systemic or inhaled steroids for more than 3 months from the date of consent
- •? Taking diuretics
- •? Patients at risk for secondary osteoporosis
- •7) Patients who have participated in other clinical trials within 3 months
- •8) Patients with a history of malignant tumors within 5 years
- •9) Those who have a history of hypersensitivity to the main ingredients and additives of the trial drugs
- •10) Patients with type 1 diabetes or diabetic ketoacidosis
- •11) Patients with genetic problems such as galactose intolerance, Lapp deficiency, or glucose-galactose malabsorption
- •12) Any other patient that the investigator has determined is unsuitable for this clinical trial
研究者
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