This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of Glucagon for Injection (Eli Lilly).
This study will test the hypothesis that micro-doses of a new formulation of stable glucagon, Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon that has poor stability in solution, Glucagon for Injection (Eli Lilly).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The subject is given an injection of xeris glucagon
The subject is given an injection of lilly glucagon
Massachusetts General Hospital
Boston, Massachusetts, United States
Tmax
tmax for Xeris vs. Lilly (non-inferiority)
Time frame: every 2 minutes for 1 hour post-dose of each glucagon
AOCGIR
Area over the curve for glucose infusion rate in the hour following administration (AOCGIR) for Xeris vs. Lilly (non-inferiority)
Time frame: every 2 minutes for 1 hour post-dose of each glucagon
GIRmin
Minimal glucose infusion rate (GIRmin) for Xeris vs. Lilly (non-inferiority)
Time frame: every 2 minutes for 1 hour post-dose of each glucagon
t½Max
Glucagon t½max for Xeris vs. Lilly (non-inferiority)
Time frame: every 2 minutes for 1 hour post-dose of each glucagon
Injection Pain
Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -average Injection pain on a 10 cm standard VAS: 0 = no pain, 10 = worst imaginable pain reported immediately after injection of glucagon
Time frame: immediately after injection
Injection Site Erythema
Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -Injection site erythema or other local reaction, maximum diameter within 1 hour of injection
Time frame: within 1 hour of injection
Maximal Nausea
Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -Maximal nausea within 1 hour of injection on a 10 cm VAS: no nausea = 0, vomiting = 10
Time frame: within 1 hour of injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dermal Response (Draize Scale for Erythema and Eschar Formation)
Average grade on the erythema and eschar formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest)
Time frame: within 1 hour of injection
Dermal Response (Draize Scale Grade for Edema Formation)
Average grade on the edema formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest)
Time frame: within 1 hour of injection