Tofogliflozin does not delay progression of carotid atherosclerosis in patients with type 2 diabetes: a prospective, randomized, open-label, parallel-group comparative study

Table 2 Effects of tofogliflozin on intima-media thickness

	Tofogliflozin group	Conventional group	Treatment effect (tofogliflozin-conventional treatment) (mean change; 95%CI), P value	P value between groups
Common mean IMT
Baseline (mm)	0.87 ± 0.16 (n = 169)	0.87 ± 0.16 (n = 170)		0.93
Week 52 (mm)	0.78 ± 0.14 (n = 155)	0.78 ± 0.14 (n = 160)		0.90
Week 104 (mm)	0.74 ± 0.14 (n = 152)	0.73 ± 0.14 (n = 149)		0.58
Week 52 (mean change; SE)	− 0.082 (0.006) §	− 0.083 (0.005) §	0.001 (− 0.012, 0.014), P = 0.89
Week 104 (mean change; SE)	− 0.132 (0.007) §	− 0.140 (0.006) §	0.008 (− 0.009, 0.025), P = 0.34
Right maximum IMT
Baseline (mm)	1.05 ± 0.29 (n = 169)	1.06 ± 0.25 (n = 169)		0.76
Week 52 (mm)	0.96 ± 0.28 (n = 155)	0.95 ± 0.23 (n = 159)		0.75
Week 104 (mm)	0.91 ± 0.30 (n = 152)	0.88 ± 0.21 (n = 148)		0.41
Week 52 (mean change; SE)	− 0.107 (0.012) §	− 0.119 (0.011) §	0.013 (− 0.015, 0.040), P = 0.37
Week 104 (mean change; SE)	− 0.163 (0.013) §	− 0.190 (0.012) §	0.027 (− 0.005, 0.059), P = 0.10
Left maximum IMT
Baseline (mm)	1.13 ± 0.37 (n = 169)	1.12 ± 0.37 (n = 169)		0.79
Week 52 (mm)	1.01 ± 0.34 (n = 155)	1.01 ± 0.33 (n = 159)		0.95
Week 104 (mm)	0.96 ± 0.38 (n = 152)	0.93 ± 0.31 (n = 148)		0.45
Week 52 (mean change; SE)	− 0.117 (0.018) §	− 0.108 (0.018) §	− 0.009 (− 0.053, 0.036), P = 0.70
Week 104 (mean change; SE)	− 0.170 (0.020) §	− 0.190 (0.020) §	0.020 (− 0.030, 0.070), P = 0.43

Data are presented as mean ± SD, unless stated otherwise. Comparisons of IMT values during treatment with those at baseline were performed using a one-sample t-test based on the mixed-effects model for repeated measures. *P < 0.05, ^#P < 0.01, §P < 0.001. Differences in IMT between groups at each point were analyzed using Student’s t-test. Differences in delta change in IMT from baseline to week 52 and 104 between groups at each point (Treatment effect) were analyzed with the mixed-effects model for repeated measures. Treatment group, week, interactions between treatment group and week, age, sex, use of insulin at baseline, and baseline IMT were included as fixed effects. IMT, intima-media thickness

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