A Clinical Trial to Evaluate the Bone Metabolism and the Blood Sugar of Evogliptin and Dapagliflozin

Sponsor
Kyung Hee University Hospital at Gangdong
Study ID
NCT04706637
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Evogliptin — DRUG
    evogliptin 5mg + metformin, oral administration once a day for 48 weeks
  • Dapagliflozin — DRUG
    dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks

Study Details

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.

Key Dates

Start date
Feb 1, 2021
Status verified
Dec 2020
Primary completion
Jan 31, 2022
Completion
Jan 31, 2023

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: evogliptin
    evogliptin 5 mg + metformin, oral administration once a day for 48 weeks
  • Active Comparator: dapagliflozin
    dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks

Primary Outcome Measure

Change of bone density [ Time Frame: Screening, 48 weeks ]

Central Contacts

Related Studies