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Table 2 Clinical outcomes

From: Correction to: Efficacy and Safety of Luseogliflozin in Patients with Type 2 Diabetes Complicated by Hepatic Dysfunction: A Single-Site, Single-Arm, Open-Label, Exploratory Trial

Endpoint Week Measurement Change
n Mean ± SD n Mean ± SD p value
NAFLD fibrosis score 0 55 − 0.78 ± 1.07    
  12 53 − 0.92 ± 1.12 53 − 0.18 ± 0.55 0.0212
  24 52 − 1.03 ± 0.96 52 − 0.31 ± 0.63 0.0008
  52 49 − 0.99 ± 1.02 49 − 0.22 ± 0.52 0.0051
FIB-4 index 0 55 1.22 ± 0.67    
  12 54 1.06 ± 0.46 54 − 0.17 ± 0.40 0.0030
  24 52 1.01 ± 0.43 52 − 0.23 ± 0.43 0.0003
  52 49 1.04 ± 0.50 49 − 0.19 ± 0.33 0.0002
Type IV collagen 7S domain (ng/mL) 0 55 4.6 ± 1.2    
  24 52 4.6 ± 0.8 52 0.0 ± 1.0 0.8387
  52 49 4.6 ± 0.7 49 0.1 ± 1.0 0.4492
Ferritin (ng/mL) 0 55 191.4 ± 144.9    
  24 52 123.9 ± 113.2 52 − 64.6 ± 73.1  < 0.0001
  52 49 113.6 ± 97.9 49 − 76.9 ± 74.2  < 0.0001
hs-CRP (mg/dL) 0 55 0.12 ± 0.13    
  24 52 0.09 ± 0.10 52 − 0.02 ± 0.11 0.1222
  52 49 0.08 ± 0.11 49 − 0.03 ± 0.13 0.0968
IL-6 (pg/mL) 0 55 2.1 ± 2.7    
  52 49 1.6 ± 1.2 49 − 0.3 ± 1.1 0.0847
Body weight (kg) 0 55 80.4 ± 14.9    
  12 53 77.5 ± 14.0 53 − 1.9 ± 1.3  < 0.0001
  24 52 78.0 ± 14.0 52 − 2.6 ± 1.8  < 0.0001
  52 50 77.6 ± 14.2 50 − 3.1 ± 2.5  < 0.0001
BMI (kg/m2) 0 55 29.2 ± 4.0    
  12 53 28.3 ± 4.0 53 − 0.7 ± 0.5  < 0.0001
  24 52 28.3 ± 3.8 52 − 0.9 ± 0.7  < 0.0001
  52 50 28.0 ± 3.8 50 − 1.1 ± 0.9  < 0.0001
Waist circumstance (cm) 0 55 98.5 ± 9.9    
  12 53 97.0 ± 10.2 53 − 1.6 ± 3.0 0.0003
  24 52 97.2 ± 9.9 52 − 1.6 ± 3.2 0.0006
  52 47 96.7 ± 10.3 47 − 2.4 ± 3.2  < 0.0001
Systolic blood pressure (mm Hg) 0 55 131.9 ± 11.9    
  12 53 127.4 ± 11.6 53 − 4.4 ± 13.0 0.0172
  24 52 130.5 ± 11.2 52 − 1.0 ± 13.2 0.6019
  52 50 129.8 ± 12.5 50 − 1.9 ± 14.6 0.3565
Diastolic blood pressure (mmHg) 0 55 81.3 ± 9.5    
  12 53 79.2 ± 8.8 53 − 2.1 ± 9.4 0.1178
  24 52 78.7 ± 8.7 52 − 2.4 ± 9.4 0.0731
  52 50 79.8 ± 8.5 50 − 1.4 ± 10.2 0.3223
Pulse 0 53 75.0 ± 10.7    
  12 52 74.3 ± 11.8 50 − 0.3 ± 9.7 0.8163
  24 52 73.7 ± 11.6 50 − 1.3 ± 8.6 0.2809
  52 48 73.8 ± 12.0 46 − 0.8 ± 8.1 0.4930
Fasting plasma glucose (mg/dL) 0 55 148.8 ± 20.7    
  12 54 131.3 ± 17.7 54 − 17.9 ± 15.5  < 0.0001
  24 52 133.2 ± 23.5 52 − 16.8 ± 20.2  < 0.0001
  52 50 130.4 ± 19.8 50 − 18.8 ± 19.5  < 0.0001
Plasma insulin (μU/mL) 0 55 12.8 ± 7.0    
  12 53 10.9 ± 5.7 53 − 2.0 ± 4.6 0.0026
  24 52 11.0 ± 5.8 52 − 2.0 ± 5.0 0.0065
  52 49 11.1 ± 6.9 49 − 1.7 ± 5.4 0.0323
HOMA-β (%) 0 55 55.6 ± 30.1    
  12 53 59.3 ± 28.3 53 3.8 ± 25.3 0.2802
  24 52 61.0 ± 32.1 52 5.7 ± 29.4 0.1710
  52 49 61.5 ± 35.3 49 6.8 ± 26.0 0.0714
HOMA-IR 0 55 4.8 ± 2.7    
  12 53 3.6 ± 2.1 53 − 1.2 ± 1.7  < 0.0001
  24 52 3.7 ± 2.2 52 − 1.2 ± 1.8  < 0.0001
  52 49 3.6 ± 2.4 49 − 1.1 ± 2.2 0.0007
  1. Data are presented as n and mean ± standard deviation
  2. NAFLD fibrosis score nonalcoholic fatty liver disease fibrosis score, FIB-4 fibrosis-4, hs-CRP high-sensitivity C-reactive protein, IL-6 interleukin-6, BMI body mass index, HOMA-β homeostatic model assessment beta, HOMA-IR homeostatic model assessment of insulin resistance