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.
This is a 52 weeks, randomized, open-label, parallel-group, multi-centres phase IV study. Participants will be randomized 1:1 to receive dapagliflozin 10 mg qd or glimepiride 1\~2 mgqd in an open-label manner for 12 months as add-on to metformin 1000 mg. Parallel group study design was chosen. In order maintain the practicality of the phase IV study, open label design of study drug delivery was chosen. The reading of the DXA scans will be conducted by one expert in blinded manner. Glimepiride is the most frequently used SUs in Korea and therefore this was chosen as comparator.Dapagliflozin treatment will be associated with reduction of total body FM, BW, abdominal VAT and SAT volume compared with glimepiride.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Subject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment
Subject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment
Research Site
Ansan-si, South Korea
Research Site
Changwon-si, South Korea
Research Site
Daegu, South Korea
Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan
Adjusted mean changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Time frame: From baseline to Week 52
Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan
Adjusted mean percent changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Time frame: From baseline to Week 52
Adjusted Mean Change in HbA1c at Week 52
Adjusted Mean Change in HbA1c at Week 52
Time frame: From baseline to Week 52
HbA1c <7.0% at Week 52
HbA1c \<7.0% at Week 52
Time frame: 52 weeks
Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Total Body Weight at Week 52
Adjusted Mean Change in Total Body Weight at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Waist Circumference at Week 52
Adjusted Mean Change in Waist Circumference at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Body Mass Index (BMI) at Week 52
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Research Site
Daejeon, South Korea
Research Site
Goyang-si, South Korea
Research Site
Incheon, South Korea
Research Site
Seongnam-si, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
...and 4 more locations
Adjusted Mean Change in Body Mass Index (BMI) at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52
Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) Area at Week 52
Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Lean Body Mass at Week 52
Adjusted Mean Change in Lean Body Mass at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Adinopectin at Week 52
Adjusted Mean Change in Adinopectin at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
Time frame: From baseline to Week 52