Table 2

Secondary outcomes

Empagliflozin 2.5 mgEmpagliflozin 10 mgEmpagliflozin 25 mgP value for differences vs. placebo
Weight, kg
 EASE-2 (26 weeks)−2.7−3.3<0.0001 for both doses
 EASE-2 (52 weeks)*−3.2−3.6<0.0001 for both doses*
 EASE-3 (26 weeks)−1.8*−3.0−3.4<0.0001 for all
CGM-derived time in glucose range of >70 to ≤180 mg/dL, % (h/day)
 EASE-2 (26 weeks)+11.9 (+2.9 h/day)+12.9 (+3.1 h/day)<0.0001 for both doses
 EASE-2 (52 weeks)*+12.2 (+2.9 h/day)+12.5 (+3.0 h/day)<0.0001 for both doses*
 EASE-3 (26 weeks)+4.3 (+1.0 h/day)+10.7 (+2.6 h/day)+7.4 (+1.8 h/day)<0.0001 for 10 mg; <0.01 for 25 mg
CGM-derived IQR, mg/dL
 EASE-2 (26 weeks)−16.9−19.0<0.0001 for both doses
 EASE-2 (52 weeks)*−19.8−19.4<0.0001 for both doses*
 EASE-3 (26 weeks)−7.9−14.6−10.7<0.01 for 10 mg; <0.05 for 25 mg
Total daily insulin dose, %
 EASE-2 (26 weeks)−13.3−12.7<0.0001 for both doses
 EASE-2 (52 weeks)*−12.0−12.9<0.0001 for both doses*
 EASE-3 (26 weeks)−6.4−9.5−12.6<0.0001 for all
SBP/DBP, mmHg
 EASE-2 (26 weeks)−2.1/−1.3−3.7/−2.3SBP: <0.05 for 10 mg*; <0.001 for 25 mg
DBP: <0.05 for 10 mg*; <0.001 for 25 mg
 EASE-2 (52 weeks)*−3.4/−1.7−4.7/−1.5SBP: <0.01 for 10 mg*; <0.0001 for 25 mg*
DBP: <0.05 for both doses*
 EASE-3 (26 weeks)−2.1/−0.3−3.9/−1.7−3.7/−1.4SBP: <0.05 for 2.5 mg*; <0.0001 for 10 mg and 25 mg
DBP: <0.01 for 10 mg*; <0.05 for 25 mg*
  • Data are adjusted mean differences vs. placebo in changes from baseline based on mixed-model repeated measures, except for EASE-2 CGM data at week 26, which were performed using ANCOVA. Analyses were performed in randomized patients treated with ≥1 dose of study drug who had a baseline and ≥1 on-treatment HbA1c measurement. DBP, diastolic blood pressure; SBP, systolic blood pressure.

  • *Nominal.

  • †Substudy.