Table 1.

Primary and secondary outcomes at 24 weeks

	Ipragliflozin n = 48	Metformin n = 50	Difference between groups
	Change from baseline (%)	Change from baseline (%)	Change from baseline (%)	95% CI	P‐value
Body composition
Visceral fat area	−12.06	−3.65	−8.40	−16.43, −3.38	0.040
Subcutaneous fat area	−7.03	2.15	−9.18	−15.34, −3.03	0.004
Total fat area	−7.98	0.37	−8.35	−13.98, −2.72	0.004
Body weight	−2.88	−0.74	−2.15	−3.31, −0.98	0.0004
BMI	−2.88	−0.74	−2.15	−3.31, −0.98	0.0004
Waist circumference	−2.85	−0.37	−2.48	−3.92, −1.03	0.001
Glycaemic control
HbA1c	−8.70	−12.73	4.03	0.79, 7.27	0.015
Fasting plasma glucose	−12.22	−14.15	1.93	−4.47, 8.33	0.551
Fasting insulin levela	−20.73	0.85	−18.56	−34.20, −2.80	0.018
HOMA‐betaa	9.05	26.04	−22.51	−37.79, −2.18	0.029
HOMA‐Ra	−25.25	0.00	−17.08	−32.86, −1.91	0.024
Blood lipid panels
Total cholesterol	1.65	−5.94	7.60	3.07, 12.12	0.001
Triglyceridea	−14.46	0.86	−11.49	−24.92, 4.23	0.165
LDL‐cholesterol	3.06	−7.57	10.63	2.81, 18.44	0.008
HDL‐cholesterol	8.74	1.51	7.22	2.10, 12.34	0.006
Other assessments
Systolic blood pressure	−2.98	−2.19	−0.79	−4.99, 3.41	0.710
Diastolic blood pressure	−2.93	0.61	−3.54	−8.88, 1.81	0.192
Adiponectin	8.33	2.20	6.13	−1.22, 13.47	0.101
hs‐CRPa	−10.18	−18.75	7.48	−17.89, 34.62	0.590

Note: Changes at 24 weeks from baseline are shown as means unless otherwise indicated.

Abbreviations: BMI, body mass index; CI, confidence interval; HOMA, homeostatic model assessment; hs‐CRP, high sensitivity C‐reactive protein.

^aThe data were not normally distributed and had outliers; non‐parametric analysis (Wilcoxon rank sum test and group difference confidence interval by Hodges‐Lehmann estimator) was performed. Changes from baseline are shown as median.