None listed
Conditions
Interventions
Drug : If a subject voluntarily agrees to participate and meets the inclusion and exclusion criteria for the clinical trial, the subject will be randomly assigned to one of the two arms.
1) Arm 1: 5 m
Sponsors
Kyung Hee University Hospital at Gangdong
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Postmenopausal women between 40 and 80 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 3) Obtained written informed consent from a patient 4) Patients who can participate during clinical trials and perform all planned trial procedures and visits.
Exclusion criteria
Exclusion criteria: 1) A person who has taken diabetes medications other than metformin (e.g., insulin, DPP4 inhibitors, SGLT-2 inhibitors, a-glucosidase inhibitors, Meglitinide) within 4 weeks before screening, or has a history of hypersensitivity to DPP4 inhibitors or SGLT2 inhibitors 2) A person who has used GLP-1 RA within 12 weeks before screening 3) A person who has taken Thiazolidinedione within 24 weeks before screening 4) AST or ALT exceeds 3 times the upper limit of the normal range in laboratory tests within 4 weeks before screening 5) Patients with moderate or severe renal impairment, end-stage renal disease (ESRD), or on dialysis 6) Patients whose eGFR (calculated using the MDRD formula) based on serum creatinine results within 4 weeks before screening or at screening is less than 60 mL/minute/1.73 m² 7) In case of osteoporosis medication history as follows - Patients who have used bisphosphonates or denosumab within 5 years - Patients who have used female hormones or SERM formulations within 12 months before screening 8) Patients with bone or mineral metabolic diseases or who have received treatments that affect bone metabolism ? Steroid - Continuous oral steroid use of 2.5 mg or more for over 3 months before screening - Continuous use of systemic or inhaled steroids for over 3 months before screening ? Currently taking diuretics ? Patients at risk of secondary osteoporosis 9) Patients who have participated in other clinical trials within 3 months before screening 10) Patients with a history of malignant tumors within 5 years before screening 11) Those who have a history of hypersensitivity to the main ingredients and additives of the investigational drugs and control drugs 12) Patients with type 1 diabetes or diabetic ketoacidosis 13) Patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 14) Any other patient that the investigator has determined is unsuitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| diabetes related indicators(HbA1C, FBS, insulin, c-peptide, AGE, CGM);adverse event;vital signs(blood pressure, pulse);lab test | — |
Countries
Korea, Republic of
Contacts
Public ContactHo Yeon Chung
Kyung Hee University Hospital at Gangdong
Outcome results
None listed