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Table 2 Changes from baseline to week 24 in clinical parameters, grouped according to baseline metformin use

From: Comparison of the clinical effect of empagliflozin on glycemic and non-glycemic parameters in Japanese patients with type 2 diabetes and cardiovascular disease treated with or without baseline metformin

Variables Metformin No metformin
Empagliflozin (n = 25) Placebo (n = 28) P value* Empagliflozin (n = 27) Placebo (n = 25) P value*
Systolic blood pressure (mmHg)
 Baseline 136.0 ± 15.9 134.5 ± 15.9 0.733 129.9 ± 14.1 131.4 ± 12.9 0.690
 Week 24 123.8 ± 14.4 132.1 ± 12.5 0.031 126.0 ± 14.6 128.8 ± 14.6 0.503
 Change from baseline to week 24 − 12.0 ± 14.9 − 2.4 ± 10.9 0.012 − 3.5 ± 17.1 − 1.9 ± 13.7 0.718
Diastolic blood pressure (mmHg)
 Baseline 77.3 ± 12.3 75.5 ± 8.6 0.557 75.6 ± 11.0 74.3 ± 10.6 0.671
 Week 24 72.0 ± 10.8 74.6 ± 11.7 0.420 73.2 ± 7.6 74.9 ± 11.0 0.536
 Change from baseline to week 24 − 5.0 ± 8.2 − 1.0 ± 9.5 0.110 − 2.5 ± 9.1 0.8 ± 10.5 0.243
Heart rate (bpm)
 Baseline 75.3 ± 12.7 71.2 ± 10.1 0.202 72.5 ± 14.0 72.7 ± 9.7 0.952
 Week 24 72.4 ± 11.6 70.4 ± 9.7 0.495 75.8 ± 19.5 71.6 ± 11.0 0.351
 Change from baseline to week 24 − 2.3 ± 9.8 − 0.8 ± 7.2 0.547 3.1 ± 19.1 − 0.4 ± 9.8 0.410
Double product
 Baseline 10,166.64 ± 1683.93 9607.00 ± 1922.19 0.264 9499.78 ± 2440.30 9594.64 ± 1813.02 0.874
 Week 24 8916.54 ± 1517.31 9344.29 ± 1781.22 0.354 9502.46 ± 2314.20 9214.26 ± 1811.87 0.628
 Change from baseline to week 24 − 1147.13 ± 1693.95 − 262.71 ± 1082.76 0.034 3.46 ± 2711.37 − 223.91 ± 1400.61 0.710
Body mass index (kg/m2)
 Baseline 26.24 ± 6.11 27.41 ± 6.35 0.496 26.29 ± 4.04 26.11 ± 4.43 0.876
 Week 24 25.40 ± 5.75 27.36 ± 6.03 0.236 25.94 ± 4.14 25.95 ± 4.69 0.995
 Change from baseline to week 24 − 1.02 ± 0.83 − 0.05 ± 0.98  < .001 − 0.48 ± 1.03 − 0.17 ± 0.86 0.246
Fasting plasma glucose (mg/dL)
 Baseline 141.17 ± 21.40 150.46 ± 28.67 0.188 141.69 ± 28.26 141.75 ± 40.94 0.995
 Week 24 121.17 ± 22.74 145.50 ± 41.50 0.011 134.70 ± 26.38 145.57 ± 44.97 0.324
 Change from baseline to week 24 − 22.30 ± 19.86 − 4.96 ± 40.70 0.054 − 13.57 ± 23.50 4.26 ± 33.69 0.044
Glycohemoglobin (%)
 Baseline 7.30 ± 0.72 7.33 ± 0.65 0.864 7.02 ± 0.89 7.05 ± 1.08 0.916
 Week 24 6.95 ± 0.61 7.52 ± 0.81 0.006 6.87 ± 0.67 6.95 ± 0.83 0.704
 Change from baseline to week 24 − 0.35 ± 0.42 0.19 ± 0.62  < .001 − 0.15 ± 0.54 − 0.08 ± 0.79 0.703
Glycoalbumin (%)
 Baseline 18.50 ± 2.68 18.50 ± 2.83 0.996 17.78 ± 3.41 18.45 ± 3.97 0.541
 Week 24 17.00 ± 2.40 18.73 ± 3.07 0.027 16.58 ± 3.26 17.97 ± 3.81 0.188
 Change from baseline to week 24 − 1.51 ± 1.60 0.23 ± 1.68  < .001 − 1.23 ± 1.99 0.03 ± 2.67 0.087
NT-proBNP (pg/mL)
 Baseline 54.64 (32.35 to 92.28) 42.75 (27.33 to 66.88) 0.467 92.07 (52.02 to 162.96) 158.56 (79.24 to 317.25) 0.217
 Week 24 51.23 (31.79 to 82.55) 37.24 (23.54 to 58.92) 0.326 85.19 (49.55 to 146.46) 138.01 (75.76 to 251.39) 0.223
 Proportional change from baseline to week 24 0.97 (0.76 to 1.23) 0.87 (0.67 to 1.14) 0.551 1.03 (0.77 to 1.36) 0.92 (0.69 to 1.22) 0.579
hs-TnI (pg/mL)
 Baseline 3.64 (2.73 to 4.86) 3.20 (2.45 to 4.18) 0.501 5.02 (2.89 to 8.72) 8.78 (4.68 to 16.44) 0.174
 Week 24 3.22 (2.33 to 4.45) 3.06 (2.26 to 4.14) 0.813 6.36 (3.30 to 12.26) 9.54 (5.07 to 17.95) 0.362
 Proportional change from baseline to week 24 0.85 (0.71 to 1.03) 0.92 (0.82 to 1.04) 0.490 1.16 (1.02 to 1.32) 1.20 (0.94 to 1.54) 0.788
  1. Data are expressed as mean ± SD or geometric mean (95% confidence interval) for NT-proBNP and hs-TnI
  2. hs-TnI high-sensitivity Troponin-I, NT-proBNP N-terminal pro-brain natriuretic peptide
  3. * Empagliflozin vs. placebo