A multicenter exploratory clinical trial to evaluate the bone metabolism and the blood sugar of evogliptin and dapagliflozin in the menopause female patients with osteopenia and type 2 diabetes.
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005710
- Lead Sponsor
- Kyung Hee University Hospital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 120
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.
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
? Steroid
- 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method bone density(lumbar spine 1-4, neck of femur, whole femur);bone markers(CTX, P1NP);other bone metabolism indicators(25OHD, PTH-Intact, FGF23, 24 hr urine Ca ,P, Cr)
- Secondary Outcome Measures
Name Time Method diabetes related indicators(HbA1C, FBS, insulin, c-peptide, AGE, CGM);adverse event;vital signs(blood pressure, pulse);lab test