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Table 3 Effects of tofogliflozin on clinical laboratory tests

From: Tofogliflozin long-term effects on atherosclerosis progression and major clinical parameters in patients with type 2 diabetes mellitus lacking a history of cardiovascular disease: a 2-year extension study of the UTOPIA trial

 

Observation point

Tofogliflozin group

Conventional treatment group

Intergroup p value for measurements

Treatment effect; mean intergroup difference in change (95% CI) (intergroup p value)

Measurement

Change from baseline

(intragroup p value)

Measurement

Change from baseline

(intragroup p value)

Body Mass Index (kg/m2)

Week 0

26.7 ± 5.4

(n = 146)

 

26.7 ± 4.4

(n = 144)

 

0.99

 

Week 104

25.8 ± 5.5

(n = 145)

− 0.9 ± 1.4

(p < 0.001)

26.6 ± 4.2

(n = 144)

− 0.2 ± 1.8

(p = 0.21)

0.20

− 0.7 (− 1.1, − 0.4)

(p < 0.001)

Week 208

25.5 ± 4.9

(n = 143)

− 1.2 ± 2.3

(p < 0.001)

26.1 ± 4.0

(n = 137)

− 0.6 ± 2.1

(p = 0.001)

0.28

− 0.6 (− 1.2, − 0.1)

(p = 0.021)

Waist circumference (cm)

Week 0

92.5 ± 12.1

(n = 131)

 

93.1 ± 11.2

(n = 130)

 

0.71

 

Week 104

91.8 ± 13.3

(n = 126)

− 1.2 ± 6.1

(p = 0.039)

94.3 ± 10.8

(n = 129)

1.4 ± 4.3

(p < 0.001)

0.11

− 2.6 (− 3.9, − 1.2)

(p < 0.001)

Week 208

90.5 ± 11.9

(n = 108)

− 1.5 ± 6.0

(p = 0.011)

93.4 ± 9.6

(n = 111)

0.4 ± 5.1

(p = 0.48)

0.05

− 1.9 (− 3.4, − 0.3)

(p = 0.016)

HbA1c (%)

Week 0

7.4 ± 0.7

(n = 146)

 

7.3 ± 0.7

(n = 145)

 

0.09

 

Week 104

7.1 ± 0.7

(n = 146)

− 0.3 ± 0.8

(p < 0.001)

7.3 ± 0.9

(n = 144)

0.1 ± 0.7

(p = 0.24)

0.006

− 0.4 (− 0.6, − 0.2)

(p < 0.001)

Week 208

7.2 ± 0.8

(n = 145)

− 0.2 ± 0.8

(p = 0.001)

7.3 ± 0.8

(n = 140)

0.0 ± 0.8

(p = 0.97)

0.48

− 0.2 (− 0.4, 0.0)

(p = 0.019)

HbA1c (mmol/mol)

Week 0

57.6 ± 7.9

(n = 146)

 

56.0 ± 7.7

(n = 145)

 

0.09

 

Week 104

53.8 ± 8.0

(n = 146)

− 3.8 ± 8.2

(p < 0.001)

56.8 ± 10.2

(n = 144)

0.7 ± 7.4

(p = 0.24)

0.006

− 4.5 (− 6.3, − 2.7)

(p < 0.001)

Week 208

55.1 ± 8.5

(n = 145)

− 2.5 ± 9.1

(p = 0.001)

55.9 ± 8.9

(n = 140)

0.0 ± 8.5

(p = 0.97)

0.48

− 2.5 (− 4.5, − 0.4)

(p = 0.019)

Fasting blood glucose (mmol/L)

Week 0

7.9 ± 1.8

(n = 146)

 

7.8 ± 1.9

(n = 145)

 

0.86

 

Week 104

7.2 ± 1.5

(n = 140)

− 0.7 ± 1.8

(p < 0.001)

8.0 ± 2.0

(n = 141)

0.1 ± 1.8

(p = 0.41)

 < 0.001

− 0.8 (− 1.3, − 0.4)

(p < 0.001)

Week 208

7.5 ± 1.8

(n = 131)

− 0.4 ± 2.2

(p = 0.033)

7.9 ± 2.3

(n = 126)

0.0 ± 2.5

(p = 0.92)

0.11

− 0.4 (− 1.0, 0.2)

(p = 0.18)

Serum creatinine (mg/dL)

Week 0

0.73 ± 0.20

(n = 145)

 

0.73 ± 0.20

(n = 144)

 

0.96

 

Week 104

0.75 ± 0.22

(n = 146)

0.02 ± 0.11

(p = 0.012)

0.76 ± 0.23

(n = 145)

0.03 ± 0.10

(p = 0.001)

0.77

− 0.01 (− 0.03, 0.02)

(p = 0.61)

Week 208

0.77 ± 0.22

(n = 143)

0.05 ± 0.12

(p < 0.001)

0.82 ± 0.43

(n = 137)

0.10 ± 0.32

(p < 0.001)

0.17

− 0.05 (− 0.11, 0.00)

(p = 0.07)

UAE

(ln(mg/g・Cr))

Week 0

2.86 ± 1.41

(n = 138)

 

3.10 ± 1.61

(n = 134)

 

0.19

 

Week 104

2.76 ± 1.48

(n = 145)

− 0.09 ± 1.00

(p = 0.31)

3.20 ± 1.67

(n = 140)

0.14 ± 0.85

(p = 0.07)

0.019

− 0.22 (− 0.44, 0.00)

(p = 0.05)

Week 208

3.00 ± 1.34

(n = 131)

0.16 ± 0.99

(p = 0.07)

3.31 ± 1.71

(n = 130)

0.19 ± 1.16

(p = 0.07)

0.10

− 0.02 (− 0.29, 0.24)

(p = 0.86)

eGFR (mL/min/1.73m2)

Week 0

80.6 ± 20.7

(n = 145)

 

81.6 ± 24.6

(n = 144)

 

0.69

 

Week 104

77.6 ± 19.4

(n = 146)

− 2.9 ± 11.9

(p = 0.004)

78.2 ± 23.2

(n = 145)

− 3.4 ± 10.3

(p < 0.001)

0.82

0.4 (− 2.1, 3.0)

(p = 0.74)

Week 208

74.4 ± 18.2

(n = 143)

− 6.4 ± 12.7

(p < 0.001)

73.9 ± 22.7

(n = 137)

− 8.4 ± 13.3

(p < 0.001)

0.84

1.9 (− 1.2, 5.0)

(p = 0.22)

Total cholesterol (mmol/L)

Week 0

4.97 ± 0.74

(n = 144)

 

4.92 ± 0.78

(n = 140)

 

0.57

 

Week 104

5.04 ± 0.87

(n = 145)

0.07 ± 0.68

(p = 0.20)

4.86 ± 0.85

(n = 139)

− 0.05 ± 0.66

(p = 0.33)

0.08

0.13 (− 0.03, 0.28)

(p = 0.11)

Week 208

4.96 ± 0.94

(n = 141)

0.01 ± 0.79

(p = 0.87)

4.74 ± 0.91

(n = 136)

− 0.17 ± 0.81

(p = 0.020)

0.045

0.18 (− 0.01, 0.37)

(p = 0.07)

LDL-C (mmol/L)

Week 0

2.90 ± 0.69

(n = 145)

 

2.87 ± 0.62

(n = 145)

 

0.71

 

Week 104

2.91 ± 0.77

(n = 144)

0.00 ± 0.63

(p = 0.96)

2.81 ± 0.70

(n = 144)

− 0.07 ± 0.55

(p = 0.14)

0.26

0.07 (− 0.07, 0.20)

(p = 0.35)

Week 208

2.79 ± 0.76

(n = 140)

− 0.11 ± 0.75

(p = 0.07)

2.70 ± 0.76

(n = 136)

− 0.16 ± 0.73

(p = 0.014)

0.35

0.04 (− 0.13, 0.22)

(p = 0.64)

HDL-C (mmol/L)

Week 0

1.43 ± 0.36

(n = 146)

 

1.38 ± 0.31

(n = 145)

 

0.23

 

Week 104

1.50 ± 0.36

(n = 146)

0.07 ± 0.20

(p < 0.001)

1.42 ± 0.34

(n = 145)

0.04 ± 0.20

(p = 0.016)

0.06

0.03 (− 0.02, 0.08)

(p = 0.20)

Week 208

1.52 ± 0.39

(n = 144)

0.09 ± 0.21

(p < 0.001)

1.41 ± 0.34

(n = 140)

0.04 ± 0.23

(p = 0.037)

0.018

0.05 (0.00, 0.11)

(p = 0.039)

Triglyceride (ln(mmol/L))

Week 0

0.24 ± 0.51

(n = 146)

 

0.34 ± 0.44

(n = 145)

 

0.09

 

Week 104

0.21 ± 0.51

(n = 139)

− 0.03 ± 0.38

(p = 0.42)

0.28 ± 0.48

(n = 140)

− 0.04 ± 0.41

(p = 0.20)

0.24

0.02 (− 0.07, 0.11)

(p = 0.69)

Week 208

0.19 ± 0.50

(n = 129)

− 0.02 ± 0.41

(p = 0.52)

0.27 ± 0.51

(n = 126)

− 0.06 ± 0.40

(p = 0.08)

0.24

0.04 (− 0.06, 0.14)

(p = 0.44)

Systolic blood pressure (mmHg)

Week 0

133.5 ± 14.6

(n = 142)

 

134.1 ± 15.7

(n = 140)

 

0.74

 

Week 104

128.5 ± 14.5

(n = 145)

− 4.9 ± 15.8

(p < 0.001)

134.3 ± 17.5

(n = 144)

0.4 ± 17.3

(p = 0.80)

0.002

− 5.3 (− 9.2, − 1.4)

(p = 0.008)

Week 208

127.9 ± 15.4

(n = 143)

− 6.0 ± 15.7

(p < 0.001)

132.7 ± 16.9

(n = 137)

− 1.1 ± 19.6

(p = 0.52)

0.013

− 4.9 (− 9.1, − 0.7)

(p = 0.023)

Diastolic blood pressure (mmHg)

Week 0

78.1 ± 10.3

(n = 142)

 

79.1 ± 10.5

(n = 140)

 

0.45

 

Week 104

74.9 ± 10.4

(n = 145)

− 3.3 ± 9.9

(p < 0.001)

77.8 ± 9.9

(n = 144)

− 1.3 ± 9.6

(p = 0.13)

0.015

− 2.0 (− 4.3, 0.3)

(p = 0.08)

Week 208

74.8 ± 11.7

(n = 143)

− 3.2 ± 12.2

(p = 0.002)

77.4 ± 10.7

(n = 137)

− 1.9 ± 12.2

(p = 0.08)

0.05

− 1.4 (− 4.3, 1.5)

(p = 0.35)

  1. Data are presented as the mean ± standard deviation. Intragroup differences from the baseline were analyzed using a one-sample t-test. Intergroup differences in changes from baseline (treatment effect) were analyzed using Student’s t-test
  2. HbA1c: hemoglobin A1c; UAE: urinary albumin excretion; eGFR: estimated glomerular filtration rate; LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol; 95% CI: 95% confidence interval
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Cardiovascular Diabetology

ISSN: 1475-2840