This multi-center, randomized and exploratory clinical trial is designed to evaluate the effect of bone metabolism and blood sugar of evogliptin and dapagliflozin in the menopause female patients with osteopenia and type 2 diabetes. The trial will evaluate bone metabolism (bone markers and bone density) and blood sugar (AGE and glucose variability) after 12 weeks and 48 weeks. This clinical trial conducts in two arms, and each arm recruits 60 subjects.
This clinical trial is to evaluate the effect of bone metabolism and blood sugar of evogliptin and dapagliflozin in the menopause female patients with osteopenia and type 2 diabetes. Bone metabolism (bone markers and bone density) and blood sugar (AGE and glucose variability) after 12 weeks and 48 weeks will be evaluated. This clinical trial conducts in two arms, and each arm recruits 60 subjects. 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. The total period after the subject enrollment is 48 weeks, and a total of six visits are made with screening, baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks. Efficacy evaluation will be carried out changes on blood sugar, bone markers and density and after 12 and 48 weeks. The results of this study are intended to be a reference to future clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
evogliptin 5mg + metformin, oral administration once a day for 48 weeks
dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks
GangNeung Asan Hospital
Gangneung, Gangwondo, South Korea
Inha University Hospital
Incheon, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
Change of bone density
Change from screening bone density of lumbar spine 1-4, neck of femur and whole femur at 48 weeks
Time frame: Screening, 48 weeks
Change of CTX(C-terminal telopeptide of type I collagen)
Change from baseline bone marker CTX(C-terminal telopeptide of type I collagen) at 12 weeks and 48 weeks.
Time frame: Baseline, 12 weeks, 48 weeks
Change of P1NP(Procollagen type 1 Aminoterminal Propeptide)
Change from baseline bone marker P1NP(Procollagen type 1 Aminoterminal Propeptide) at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of 25OHD(25 Hydroxyvitamin D)
Change from baseline bone metabolism indicator 25OHD(25 Hydroxyvitamin D) at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of PTH(Parathyroid Hormone) Intact
Change from baseline bone metabolism indicator PTH(Parathyroid Hormone) Intact at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of FGF23 (Fibroblast growth factor 23)
Change from baseline bone metabolism indicator FGF23(Fibroblast growth factor 23) at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of 24 hour urine calcium
Change from baseline bone metabolism indicator 24 hour urine calcium at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of 24 hour urine phosphate
Change from baseline bone metabolism indicator 24 hour urine phosphate at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of 24 hour urine creatinine
Change from baseline bone metabolism indicator 24 hour urine creatinine at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of HbA1C
Change from baseline HbA1C at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of FBS(Fasting Blood Sugar)
Change from baseline FBS(Fasting Blood Sugar) at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of insulin
Change from baseline insulin at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of c-peptide
Change from baseline c-peptide at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of AGE(Advanced Glycation End Products)
Change from baseline AGE(Advanced Glycation End Products) at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Change of CGM(Continuous Glucose Monitoring)
Change from baseline CGM(Continuous Glucose Monitoring) at 12 weeks and 48 weeks
Time frame: Baseline, 12 weeks, 48 weeks
Adverse events
Adverse events
Time frame: 12 weeks, 24 weeks, 36 weeks, 48 weeks
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