Phase 4Status unknownAge-related condition
A Clinical Trial to Evaluate the Bone Metabolism and the Blood Sugar of Evogliptin and Dapagliflozin (EVOMETA)
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
- Sponsor
- Kyung Hee University Hospital at Gangdong (Academic or other)
- Enrolment
- 120 planned
- Conditions
- Bone Diseases, Metabolic; Diabetes Mellitus, Type 2
- Interventions
- Evogliptin; Dapagliflozin
- Ages
- adults, older adults
- Registry
- NCT04706637
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change of bone density
- Change of CTX(C-terminal telopeptide of type I collagen)
- Change of P1NP(Procollagen type 1 Aminoterminal Propeptide)
- Change of 25OHD(25 Hydroxyvitamin D)
History
Study completion
Primary completion
Started
Registered
Papers citing this trial
- Effects of Evogliptin and Dapagliflozin on Bone and Glucose Metabolism in Postmenopausal Women with Type 2 Diabetes: A Multicenter Randomized Exploratory Clinical Trial
Diabetes, metabolic syndrome and obesity : targets and therapy