The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to moderate hypoglycemia, a complication of diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
13
stable, pre-mixed, liquid glucagon for subcutaneous injection
Baylor College of Medicine, Children's Nutritional Research Center, Texas Children's Hospital
Houston, Texas, United States
Serious Adverse Events
Number of serious adverse events (SAEs) per treatment
Time frame: From first dose until follow-up call, up to 7 weeks per subject
Glucagon Cmax (Fasting)
Pharmacokinetic parameter: Maximum concentration of glucagon
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Glucagon Cmax (Post-insulin)
Pharmacokinetic parameter: Maximum concentration of glucagon
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Glucagon Area Under the Curve (AUC) (Fasting)
Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Glucagon AUC (Post-insulin)
Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Glucagon Tmax (Fasting)
Pharmacokinetic parameter: Time to reach maximum concentration of glucagon
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Glucagon Tmax (Post-insulin)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacokinetic parameter: Time to reach maximum concentration of glucagon
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Glucose Cmax (Fasting)
Pharmacodynamic parameter: Maximum concentration of glucose
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Glucose Cmax (Post-insulin)
Pharmacodynamic parameter: Maximum concentration of glucose
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Glucose AUC (Fasting)
Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Glucose AUC (Post-insulin)
Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Glucose Tmax (Fasting)
Pharmacodynamic parameter: Time to reach maximum concentration of glucose
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Glucose Tmax (Post-insulin)
Pharmacodynamic parameter: Time to reach maximum concentration of glucose
Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection