| Outcome Measures: |
Primary: Hypoglycemia Rescue: Intent-to-Treat Population, Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon, At 30 minutes following administration of study drug|Hypoglycemia Rescue: Per Protocol Population, Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon, At 30 minutes following administration of study drug|Hypoglycemia Rescue: Alternate Glucose Response Definition, Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or an increase in from baseline in plasma glucose concentration of at least 20 mg/dL within 30 minutes after administration of glucagon, At 30 minutes following administration of study drug | Secondary: Plasma Glucose Area Under the Curve (AUC), Pharmacodynamic endpoint of plasma glucose AUC from baseline to 90 minutes following administration of glucagon, At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon|Plasma Glucose Maximum Concentration (Cmax), Pharmacodynamic endpoint of plasma glucose Cmax from baseline to 4 hours following administration of glucagon, At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon|Plasma Glucose Time to Maximum Concentration (Tmax), Pharmacodynamic endpoint of plasma glucose Tmax from baseline to 4 hours following administration of glucagon, At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon|Plasma Glucose Time to Concentration > 70 mg/dL, Pharmacodynamic endpoint of time to achieve a plasma glucose concentration \> 70 mg/dL following administration of glucagon, At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon|Time to Resolution of Hypoglycemia Symptoms, Time to resolution of mean autonomic, mean neuroglycopenic and mean total hypoglycemia symptom scores from baseline through 90 minutes following administration of glucagon., At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon|Global Assessment of Hypoglycemia, Time to resolution of the overall sensation of hypoglycemia following administration of glucagon, At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon
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| Locations: |
University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States|ProSciento, Inc., Chula Vista, California, 91911, United States|AMCR Institute, Escondido, California, 92025, United States|Diablo Clinical Research, Walnut Creek, California, 94598, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States|Rainier Research, Renton, Washington, 98057, United States|LMC Diabetes & Endocrinology, Toronto, Ontario, M4G 3E8, Canada
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