Table 2.

Primary and secondary endpoints at 24 weeks

	Ipragliflozin, n = 15	Metformin, n = 14	Difference between groups (%)	95% CI		P value
	Change from baseline (%)	Change from baseline (%)
Visceral fat area (adjusted)	− 10.58	6.93	− 17.51	− 33.51	− 1.52	0.034
Visceral fat area (crude)	− 17.82	− 0.26	− 17.56	− 33.02	− 2.11	0.028
Subcutaneous fat area	− 1.95	7.13	− 9.08	− 25.62	7.45	0.268
Total fat area	− 9.07	4.10	− 13.17	− 26.79	0.46	0.058
Body weight	− 2.99	− 1.16	− 1.83	− 4.31	0.65	0.141
BMI	− 2.99	− 1.16	− 1.83	− 4.31	0.65	0.141
Waist circumference	− 2.03	1.02	− 3.05	− 6.41	0.30	0.073
Bone density	− 4.45	− 4.71	0.26	− 12.38	12.90	0.967
Abdominal muscle area	− 2.92	− 1.87	− 1.04	− 4.50	2.41	0.540
Visceral fat area/body weight	− 15.10	1.30	− 16.39	− 29.80	− 2.99	0.019
Visceral adiposity index	− 10.70	− 8.14	− 2.57	− 33.74	28.61	0.867
Handgrip strength	0.91	8.83	− 7.92	− 18.05	2.21	0.120
BAP*	− 0.77	− 7.74	12.03	− 6.14	28.62	0.182
TRACP-5b*	7.56	− 10.41	17.97	2.73	33.71	0.027
HbA1c	− 6.48	− 12.89	6.41	− 0.31	13.13	0.061
Fasting blood glucose	− 11.76	− 14.38	2.62	− 11.19	16.43	0.700
Insulin level change*	− 20.51	− 1.96	− 6.80	− 38.55	19.15	0.747
HOMA2-beta (%)*	9.61	16.01	− 7.64	− 44.30	24.65	0.608
HOMA2-R (%)*	− 21.97	− 8.19	− 11.56	− 44.22	17.65	0.510
Total cholesterol	1.11	− 8.46	9.57	2.39	16.74	0.011
LDL-C	− 0.27	− 9.86	9.59	− 2.11	21.28	0.104
HDL-C	8.49	4.80	3.70	− 4.96	12.35	0.389
Triglyceride*	− 9.29	− 7.89	− 1.86	− 28.98	28.54	0.890
Non-HDL-C	− 1.61	− 12.86	11.25	− 0.55	23.05	0.061
Uric acid	− 8.83	6.10	− 14.93	− 27.33	− 2.54	0.020
SBP	− 0.57	− 2.14	1.57	− 8.07	11.20	0.741
DBP	− 1.06	1.36	− 2.42	− 12.61	7.77	0.630
Adiponectin	6.56	4.99	1.56	− 9.55	12.67	0.775
hs-CRP*	− 21.12	− 11.76	− 10.11	− 64.55	31.70	0.519

The difference between groups corresponds to the difference between the ipragliflozin and metformin groups. Negative values indicate the superiority of ipragliflozin over metformin

The least-square mean difference in any change in the visceral fat area in 24 weeks between the two groups and its 95% confidence intervals (CIs) were estimated using analysis of covariance adjusted for baseline waist circumference, HbA1c, and baseline visceral fat area

BAP bone alkali phosphatase, HbA1c glycated hemoglobin, HOMA2 homeostasis model assessment 2, TRACP-5b tartrate-resistant acid phosphatase-5, hs-CRP high-sensitivity C-reactive protein, SBP systolic blood pressure, DBP diastolic blood pressure, LDL-C low-density lipoprotein cholesterol, HDL-C high-density lipoprotein cholesterol

^*Median and Hodges-Lehmann estimator