Table 2.

Clinical outcomes by study and treatment

Outcome	Statistic	XSGP-301*		XSGP-303*
		GAI 1 mg (n=78)	GEK 1 mg (n=79)	GAI 1 mg (n=76)	GEK 1 mg (n=78)
Participants having plasma glucose measurement >70 mg/dL (3.9 mmol/L) within 30 min after receiving glucagon	n (%)	74 (94.9)†	79 (100)	76 (100)	78 (100)
Participants having plasma glucose measurement increased 20 mg/dL (1.1 mmol/L) within 30 min after receiving glucagon	n (%)	76 (97.4)†	79 (100)	76 (100)	78 (100)
Participants having plasma glucose measurement >70 mg/dL (3.9 mmol/L) or neuroglycopenic symptom relief within 30 min after receiving glucagon	n (%)	77 (98.7)	79 (100)	76 (100)	78 (100)
Time (min) to first plasma glucose measurement >70 mg/dL (3.9 mmol/L) after receiving glucagon‡	n	78	79	76	78
	Mean±SD	19.86±8.508	14.23±4.258	12.17±3.604	8.58±2.026
	P value		Period 1: 0.0001§ Period 2: 0.0004§		Period 1:<0.0001§ Period 2:<0.0001§
Time (min) to first reporting of ‘no’ hypoglycemia after receiving glucagon‡	n	76	79	76	78
	Mean±SD	16.8±10.68	15.7±8.30	11.6±6.45	13.1±7.86
	P value		0.368		0.156
Time (min) to first reporting of ‘no’ hypoglycemia after decision to dose‡	n	NR	NR	76	78
	Mean±SD			12.69±6.446	15.26±8.008
	P value				0.020
Time (min) to minimum hypoglycemia questionnaire score after receiving glucagon – average autonomic score	n	77	79	76	78
	Mean±SD	16.0±11.48	14.2±9.40	13.8±10.89	12.0±7.44
	P value		0.241¶		0.060‡
Time (min) to minimum hypoglycemia questionnaire score after receiving glucagon – average neuroglycopenic score	n	77	79	76	78
	Mean±SD	16.7±10.22	14.3±8.97	14.2±15.12	12.2±8.85
	P value		0.107¶		0.183‡
Time (min) to minimum hypoglycemia questionnaire score after receiving glucagon – average total score	n	77	79	76	78
	Mean±SD	19.8±11.69	17.0±8.85	18.6±19.51	14.5±8.39
	P value		0.055¶		0.048‡
Dose preparation time (s)‡	n	NR	NR	76	78
	Mean±SD			27.3±19.66	97.2±45.06
	P value				Period 1:<0.0001§ Period 2:<0.0001§

*Analysis is conducted for all randomized participants based on actual treatment received. XSGP-301 statistics are based on modified intent-to-treat population. XSGP-303 statistics are based on intent-to-treat population.

†Participants successfully recovered from induced hypoglycemia without other rescue therapy after the 30 min cut-off.

‡Mixed model was applied to compare difference in treatment groups accounting for period and sequence as covariates.

§Non-normality was observed, and log transformation did not resolve. A non-parametric Kruskal-Wallis test was applied excluding other covariates and conducted for each of the treatment periods separately.

¶HR of the two treatment groups was compared using the log-rank test.

GAI, glucagon autoinjector; GEK, glucagon emergency kit; NR, not reported.