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Table 3 Changes in primary and secondary endpoints from baseline to week 24 and proportion of patients with target HbA 1c levels at week 24 (FAS)

From: Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study

Variable Placebo Tofogliflozin
   10 mg 20 mg 40 mg
HbA1c (%)     
  N 56 57 58 58
  LS mean (95% CI) −0.028 (−0.192 to 0.137) −0.797 (−0.960 to −0.634)††† −1.017 (−1.178 to −0.856)††† −0.870 (−1.031 to −0.709)†††
  Placebo-adjusted difference −0.769 −0.990 −0.842
Fasting blood glucose (mg/dL)     
  N 56 57 58 58
  LS mean (95% CI) −8.561 (−13.247 to −3.875) −31.868 (−36.514 to −27.222)††† −35.899 (−40.504 to −31.294)††† −32.327 (−36.933 to −27.722)†††
  Placebo-adjusted difference −23.307 −27.338 −23.766
Body weight (kg)     
  N 56 57 58 58
  LS mean (95% CI) −0.356 (−0.836 to 0.123) −2.230 (−2.704 to −1.756)††† −2.851 (−3.320 to −2.382)††† −2.971 (−3.440 to −2.502)†††
  Placebo-adjusted difference −1.87 −2.50 −2.61
Glycoalbumin (%)     
  N 53 55 58 58
  Mean (SD) 0.19 (2.07) −3.09 (2.19)***††† −3.52 (2.84)***††† −3.01 (2.33)***†††
2-h PPG (mg/dL)     
  N 48 53 56 53
  Mean (SD) −3.33 (47.6) −63.5 (49.0)***††† −71.0 (63.7)***††† −60.2 (47.2)***†††
Fasting insulin (μU/mL)     
  N 48 52 56 57
  Mean (SD) −0.44 (4.59) −1.36 (2.95)** −2.12 (5.81)** −2.01 (2.80)***
2-h postprandial insulin (μU/mL)     
  N 45 50 56 54
  Mean (SD) −0.26 (8.81) −4.14 (10.59)** −7.25 (13.74)***†† −5.58 (7.73)***††
HOMA-β     
  N 48 52 56 57
  Mean (SD) −0.26 (15.62) 5.15 (13.48)** 3.97 (26.70) 2.67 (12.90)
HOMA − IR     
  N 48 52 56 57
  Mean (SD) −0.296 (2.212) −1.136 (1.532)*** −1.469 (2.407)*** −1.345 (1.601)*** ††
Matsuda Index     
  N 40 45 50 49
  Mean (SD) 0.434 (2.764) 2.137 (2.447)***†† 2.233 (2.339)***†† 2.351 (1.954)***†††
Serum lipids     
Total cholesterol (mg/dL)     
  N 53 55 58 58
  Mean (SD) −6.8 (26.6) −2.5 (20.6) −3.1 (28.4) 1.1 (23.8)
LDL-cholesterol (mg/dL)     
  N 53 55 58 58
  Mean (SD) −4.3 (21.6) −2.7 (19.8) −2.2 (24.0) 4.5 (21.9)
HDL-cholesterol (mg/dL)     
  N 53 55 58 58
  Mean (SD) −0.2 (7.3) 3.3 (7.5)** 3.9 (11.0)** 4.5 (8.6)***††
Triglycerides (mg/dL)     
  N 53 55 58 58
  Mean (SD) −21.5 (206.2) −20.7 (119.1) −23.9 (83.8)* −44.5 (95.1)***
Adiponectin (μg/mL)     
  N 53 55 58 58
  Mean (SD) −0.17 (0.99) 0.71 (1.11)***††† 0.96 (1.61)***††† 0.45 (2.73)
Systolic blood pressure (mmHg)     
  N 56 57 58 58
  Mean (SD) −3.2 (13.1) −6.8 (13.1)*** −7.6 (11.4)*** −9.4 (11.1)***††
Diastolic blood pressure (mmHg)     
  N 56 57 58 58
  Mean (SD) −1.4 (9.8) −5.6 (9.8)*** −4.1 (8.4)*** −4.1 (8.3)***
Waist circumference (cm)     
  N 53 55 58 58
  Mean (SD) 0.02 (3.95) −2.42 (3.37)***††† −2.47 (2.99)***††† −2.27 (3.22)***††
  1. *P < 0.05, **P < 0.01, and ***P < 0.001 vs. baseline.
  2. P < 0.05, ††P < 0.01, and †††P < 0.001 vs. placebo.
  3. Abbreviations: LS mean least squares mean, 95% CI 95% confidence interval, NGSP National Glycohemoglobin Standardization Program, HOMA-β Homeostatic model assessment of β cell function, HOMA-IR Homeostatic model assessment of insulin resistance, 2-h PPG 2-hour postprandial glucose.