Table 2.

Responder analysis of body weight (kilograms, percent reduction from baseline) following 24 weeks of treatment with licogliflozin vs. placebo

End point/time point	Treatment group	n/M (%)	Odds ratio	95% CI	P
Percent decrease from baseline ≥ 5%	Licogliflozin 2.5 mg qd	10/38 (26.3)	2.38	0.85‐6.67	0.099
	Licogliflozin 10 mg qd	6/38 (15.8)	1.18	0.36‐3.84	0.779
	Licogliflozin 50 mg qd	13/38 (34.2)	3.69	1.35‐10.11	0.011*
	Licogliflozin 150 mg qd	33/77 (42.9)	5.57	2.41‐12.88	< 0.001*
	Licogliflozin 2.5 mg bid	6/38 (15.8)	1.15	0.36‐3.74	0.812
	Licogliflozin 5 mg bid	8/39 (20.5)	1.94	0.66‐5.69	0.229
	Licogliflozin 25 mg bid	14/37 (37.8)	4.29	1.61‐11.46	0.004*
	Licogliflozin 50mg bid	34/75 (45.3)	6.37	2.72‐14.93	< 0.001*
	Placebo	10/78 (12.8)
Percent decrease from baseline ≥ 10%	Licogliflozin 2.5mg qd	2/38 (5.3)	1.09	0.10‐12.41	0.943
	Licogliflozin 10 mg qd	2/38 (5.3)	2.11	0.28‐15.77	0.465
	Licogliflozin 50 mg qd	2/38 (5.3)	1.60	0.15‐17.15	0.696
	Licogliflozin 150 mg qd	5/77 (6.5)	2.14	0.38‐12.10	0.389
	Licogliflozin 2.5 mg bid	2/38 (5.3)	1.04	0.09‐11.87	0.976
	Licogliflozin 5 mg bid	1/39 (2.6)	1.02	0.09‐11.70	0.986
	Licogliflozin 25 mg bid	4/37 (10.8)	3.51	0.56‐22.18	0.181
	Licogliflozin 50 mg bid	7/75 (9.3)	3.97	0.77‐20.54	0.100
	Placebo	3/78 (3.8)

Statistical model used logistic regression, adjusting for treatment, glycemic status, and region with baseline body weight as covariate. Baseline defined as value at randomization visit.

^*Statistically significant.

n, number of participants who responded; M, total number of participants in treatment group with response variable defined; bid, twice a day; qd, once a day.