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Evogliptin vs Dapagliflozin in Postmenopausal Women with Osteopenia and Type 2 Diabetes
NCT04706637Phase 4
Key facts
- Status
- Unknown
- Start
- Feb 2021
- Primary completion
- Jan 2022
- Countries
- 1
- Sponsor
- Kyung Hee University Hospital
- Modality
- Small Molecules
- Drugs
- DA5221-B2
- Conditions
- type 2 diabetes mellitus (T2DM)osteopenia
01
Overview
Phase 4, randomised, open-label trial of DA5221-B2 in type 2 diabetes mellitus (T2DM) and osteopenia, sponsored by Kyung Hee University Hospital. Status: unknown.
02
Design
- Study design
- RandomizedOpen-label
03
Who it enrols
Postmenopausal women (40-70 years) with type 2 diabetes (HbA1c 7.0-9.0%) and osteopenia (T-score -2.4 to -1.0) who are either treatment-naive or on metformin monotherapy.
04
Registry description
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.
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