Foxiga Korea Local Phase 4 Study

Sponsor
AstraZeneca
Study ID
NCT02564926
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Subject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment
  • Glimepiride — DRUG
    Subject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment

Study Details

To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month, randomised, open-label, parallel-group, multi-centre phase IV study.

Key Dates

Start date
Jan 5, 2016
Status verified
Aug 2019
Primary completion
Jan 15, 2018
Completion
Jan 15, 2018

Study Design

Enrollment
125 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10mg + Metformin 1000mg
  • Active Comparator: Glimepiride
    Glimepiriide 1-2mg + Metformin 1000mg

Primary Outcome Measure

Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan [ Time Frame: From baseline to Week 52 ]

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