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/day99.5 ± 4.990.4 ± 4.089.4 ± 4.1
 Change from baseline in insulin dose, international units/day10.2 ± 2.21.3 ± 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 value0.004<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, kg96.66 ± 1.7294.57 ± 1.4793.41 ± 1.72
 Change from baseline in body weight, kg0.44 ± 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, kg95.83 ± 1.2795.71 ± 1.3094.37 ± 1.26
 Change from baseline in body weight, kg0.34 ± 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/L8.41 ± 0.198.83 ± 0.208.34 ± 0.20
 FPG at week 18, mmol/L8.68 ± 0.227.66 ± 0.197.09 ± 0.17
 Change from baseline in FPG, mmol/L0.19 ± 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/L7.95 ± 0.227.46 ± 0.227.13 ± 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 value0.0120.004
  • 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.