Table 2

Clinical outcomes by study and treatment

OutcomeStatisticXSGP-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 glucagonn (%)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 glucagonn (%)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 glucagonn (%)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‡n78797678
Mean±SD19.86±8.50814.23±4.25812.17±3.6048.58±2.026
P valuePeriod 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‡n76797678
Mean±SD16.8±10.6815.7±8.3011.6±6.4513.1±7.86
P value0.3680.156
Time (min) to first reporting of ‘no’ hypoglycemia after decision to dose‡nNRNR7678
Mean±SD12.69±6.44615.26±8.008
P value0.020
Time (min) to minimum hypoglycemia questionnaire score after receiving glucagon – average autonomic scoren77797678
Mean±SD16.0±11.4814.2±9.4013.8±10.8912.0±7.44
P value0.241¶0.060‡
Time (min) to minimum hypoglycemia questionnaire score after receiving glucagon – average neuroglycopenic scoren77797678
Mean±SD16.7±10.2214.3±8.9714.2±15.1212.2±8.85
P value0.107¶0.183‡
Time (min) to minimum hypoglycemia questionnaire score after receiving glucagon – average total scoren77797678
Mean±SD19.8±11.6917.0±8.8518.6±19.5114.5±8.39
P value0.055¶0.048‡
Dose preparation time (s)‡nNRNR7678
Mean±SD27.3±19.6697.2±45.06
P valuePeriod 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.