Table 1

Summary of changes in HbA1c, plasma glucose, insulin dose, and body weight

PlaceboEmpagliflozin
10 mg25 mg
Primary end point    
 HbA1c at baseline, % (mmol/mol) (week 18 analysis set) 8.33 ± 0.05 (68 ± 0.5) 8.39 ± 0.05 (68 ± 0.5) 8.29 ± 0.05 (67 ± 0.5) 
 HbA1c at week 18, % (mmol/mol) 7.84 ± 0.07 (62 ± 0.8) 7.44 ± 0.05 (58 ± 0.5) 7.29 ± 0.06 (56 ± 0.7) 
 Change from baseline in HbA1c, % (mmol/mol) −0.50 ± 0.05 (−5.5 ± 0.5) −0.94 ± 0.05 (−10.3 ± 0.5) −1.02 ± 0.05 (−11.1 ± 0.5) 
  Difference vs. placebo (95% CI) (%) [mmol/mol]  −0.44 ± 0.08 (−0.59 to −0.29);
[−4.8 ± 0.9 (−6.4 to −3.2)] −0.52 ± 0.07 (−0.67 to −0.37);
[−5.7 ± 0.8 (−7.3 to −4.0)] 
  P value  <0.001 <0.001 
Secondary end points    
 Insulin dose at week 52, international units/day 99.5 ± 4.9 90.4 ± 4.0 89.4 ± 4.1 
 Change from baseline in insulin dose, international units/day 10.2 ± 2.2 1.3 ± 2.1 −1.1 ± 2.1 
  Difference vs. placebo (95% CI)  −8.8 ± 3.1 (−14.8 to −2.8) −11.2 ± 3.1 (−17.2 to −5.2) 
  P value  0.004 <0.001 
 HbA1c at baseline, % (mmol/mol) (week 52 analysis set) 8.25 ± 0.07 (67 ± 0.8) 8.40 ± 0.07 (68 ± 0.8) 8.37 ± 0.06 (68 ± 0.7) 
 HbA1c at week 52, % (mmol/mol) 7.48 ± 0.09 (58 ± 1.0) 7.19 ± 0.08 (55 ± 0.9) 7.09 ± 0.08 (54 ± 0.9) 
 Change from baseline in HbA1c, % (mmol/mol) −0.81 ± 0.08 (−8.9 ± 0.9) −1.18 ± 0.08 (−12.9 ± 0.9) −1.27 ± 0.08 (−13.9 ± 0.9) 
  Difference vs. placebo (95% CI) (%) [mmol/mol]  −0.38 ± 0.11 (−0.59 to −0.16);
[−4.2 ± 1.2 (−6.4 to −1.7)] −0.46 ± 0.11 (−0.67 to −0.25);
[−5.0 ± 1.2 (−7.3 to −2.7)] 
  P value  <0.001 <0.001 
 Body weight at week 52, kg 96.66 ± 1.72 94.57 ± 1.47 93.41 ± 1.72 
 Change from baseline in body weight, kg 0.44 ± 0.36 −1.95 ± 0.36 −2.04 ± 0.36 
  Difference vs. placebo (95% CI)  −2.39 ± 0.51 (−3.40 to −1.39) −2.48 ± 0.51 (−3.48 to −1.47) 
  P value  <0.001 <0.001 
Exploratory end points    
 Body weight at week 18, kg 95.83 ± 1.27 95.71 ± 1.30 94.37 ± 1.26 
 Change from baseline in body weight, kg 0.34 ± 0.18 −0.97 ± 0.18 −1.54 ± 0.18 
  Difference vs. placebo (95% CI)  −1.31 ± 0.26 (−1.82 to −0.80) −1.88 ± 0.26 (−2.39 to −1.37) 
  P value  <0.001 <0.001 
 FPG at baseline, mmol/L 8.41 ± 0.19 8.83 ± 0.20 8.34 ± 0.20 
 FPG at week 18, mmol/L 8.68 ± 0.22 7.66 ± 0.19 7.09 ± 0.17 
 Change from baseline in FPG, mmol/L 0.19 ± 0.16 −0.98 ± 0.17 −1.36 ± 0.16 
  Difference vs. placebo (95% CI)  −1.17 ± 0.23 (−1.62 to −0.71) −1.55 ± 0.23 (−2.00 to −1.09) 
  P value  <0.001 <0.001 
 FPG at week 52, mmol/L 7.95 ± 0.22 7.46 ± 0.22 7.13 ± 0.19 
 Change from baseline in FPG, mmol/L −0.63 ± 0.19 −1.32 ± 0.19 −1.43 ± 0.19 
  Difference vs. placebo (95% CI)  −0.69 ± 0.27 (−1.23 to −0.15) −0.79 ± 0.27 (−1.33 to −0.26) 
  P value  0.012 0.004 
PlaceboEmpagliflozin
10 mg25 mg
Primary end point    
 HbA1c at baseline, % (mmol/mol) (week 18 analysis set) 8.33 ± 0.05 (68 ± 0.5) 8.39 ± 0.05 (68 ± 0.5) 8.29 ± 0.05 (67 ± 0.5) 
 HbA1c at week 18, % (mmol/mol) 7.84 ± 0.07 (62 ± 0.8) 7.44 ± 0.05 (58 ± 0.5) 7.29 ± 0.06 (56 ± 0.7) 
 Change from baseline in HbA1c, % (mmol/mol) −0.50 ± 0.05 (−5.5 ± 0.5) −0.94 ± 0.05 (−10.3 ± 0.5) −1.02 ± 0.05 (−11.1 ± 0.5) 
  Difference vs. placebo (95% CI) (%) [mmol/mol]  −0.44 ± 0.08 (−0.59 to −0.29);
[−4.8 ± 0.9 (−6.4 to −3.2)] −0.52 ± 0.07 (−0.67 to −0.37);
[−5.7 ± 0.8 (−7.3 to −4.0)] 
  P value  <0.001 <0.001 
Secondary end points    
 Insulin dose at week 52, international units/day 99.5 ± 4.9 90.4 ± 4.0 89.4 ± 4.1 
 Change from baseline in insulin dose, international units/day 10.2 ± 2.2 1.3 ± 2.1 −1.1 ± 2.1 
  Difference vs. placebo (95% CI)  −8.8 ± 3.1 (−14.8 to −2.8) −11.2 ± 3.1 (−17.2 to −5.2) 
  P value  0.004 <0.001 
 HbA1c at baseline, % (mmol/mol) (week 52 analysis set) 8.25 ± 0.07 (67 ± 0.8) 8.40 ± 0.07 (68 ± 0.8) 8.37 ± 0.06 (68 ± 0.7) 
 HbA1c at week 52, % (mmol/mol) 7.48 ± 0.09 (58 ± 1.0) 7.19 ± 0.08 (55 ± 0.9) 7.09 ± 0.08 (54 ± 0.9) 
 Change from baseline in HbA1c, % (mmol/mol) −0.81 ± 0.08 (−8.9 ± 0.9) −1.18 ± 0.08 (−12.9 ± 0.9) −1.27 ± 0.08 (−13.9 ± 0.9) 
  Difference vs. placebo (95% CI) (%) [mmol/mol]  −0.38 ± 0.11 (−0.59 to −0.16);
[−4.2 ± 1.2 (−6.4 to −1.7)] −0.46 ± 0.11 (−0.67 to −0.25);
[−5.0 ± 1.2 (−7.3 to −2.7)] 
  P value  <0.001 <0.001 
 Body weight at week 52, kg 96.66 ± 1.72 94.57 ± 1.47 93.41 ± 1.72 
 Change from baseline in body weight, kg 0.44 ± 0.36 −1.95 ± 0.36 −2.04 ± 0.36 
  Difference vs. placebo (95% CI)  −2.39 ± 0.51 (−3.40 to −1.39) −2.48 ± 0.51 (−3.48 to −1.47) 
  P value  <0.001 <0.001 
Exploratory end points    
 Body weight at week 18, kg 95.83 ± 1.27 95.71 ± 1.30 94.37 ± 1.26 
 Change from baseline in body weight, kg 0.34 ± 0.18 −0.97 ± 0.18 −1.54 ± 0.18 
  Difference vs. placebo (95% CI)  −1.31 ± 0.26 (−1.82 to −0.80) −1.88 ± 0.26 (−2.39 to −1.37) 
  P value  <0.001 <0.001 
 FPG at baseline, mmol/L 8.41 ± 0.19 8.83 ± 0.20 8.34 ± 0.20 
 FPG at week 18, mmol/L 8.68 ± 0.22 7.66 ± 0.19 7.09 ± 0.17 
 Change from baseline in FPG, mmol/L 0.19 ± 0.16 −0.98 ± 0.17 −1.36 ± 0.16 
  Difference vs. placebo (95% CI)  −1.17 ± 0.23 (−1.62 to −0.71) −1.55 ± 0.23 (−2.00 to −1.09) 
  P value  <0.001 <0.001 
 FPG at week 52, mmol/L 7.95 ± 0.22 7.46 ± 0.22 7.13 ± 0.19 
 Change from baseline in FPG, mmol/L −0.63 ± 0.19 −1.32 ± 0.19 −1.43 ± 0.19 
  Difference vs. placebo (95% CI)  −0.69 ± 0.27 (−1.23 to −0.15) −0.79 ± 0.27 (−1.33 to −0.26) 
  P value  0.012 0.004 

Data are mean ± SE except for change from baseline values and difference vs. placebo, which are adjusted mean ± SE. HbA1c, FPG, and body weight at week 18 were assessed with ANCOVA in FAS using LOCF. HbA1c, insulin dose, FPG, and body weight at week 52 were assessed with ANCOVA in PPS-completers-52 using LOCF. The FAS is patients treated with study medication who had a baseline HbA1c measurement. The PPS-completers-52 set is patients in the FAS who were on treatment up to day 357 and did not have important protocol violations.

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