| Outcome Measures: |
Primary: Adjusted Mean Change in Total Body Weight, To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment., Baseline to Week 24 | Secondary: Adjusted Mean Change in Waist Circumference, To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference., Baseline to Week 24|Adjusted Mean Change in Body Fat Mass, To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry., Baseline to Week 24|Proportion of Participants With Body Weight Decrease ≥5%, To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value., Baseline to Week 24 | Other: Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4), To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry., Baseline to Week 102|Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck, To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry., Baseline to Week 102|Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip, To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry., Baseline to Week 102
|
| Locations: |
Research Site, Blagoevgrad, Bulgaria|Research Site, Sofia, Bulgaria|Research Site, Beroun, Czech Republic|Research Site, Brno, Czech Republic|Research Site, Praha, Czech Republic|Research Site, Semily, Czech Republic|Research Site, Slany, Czech Republic|Research Site, Balatonfured, Hungary|Research Site, Budapest, Hungary|Research Site, Csongrad, Hungary|Research Site, Kecskemet, Hungary|Research Site, TAT, Hungary|Research Site, Elblag, Poland|Research Site, Krakow, Poland|Research Site, Torun, Poland|Research Site, Goteborg, Sweden|Research Site, Jarfalla, Sweden|Research Site, Lund, Sweden|Research Site, Malmo, Sweden|Research Site, Stockholm, Sweden|Research Site, Uppsala, Sweden
|
