The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.
Primary objective: To Evaluate the Safety and Tolerability of G-Pen™ (Glucagon Injection) 1 mg Secondary objective (1): To Evaluate the pharmacodynamics (Efficacy) of G-Pen™ (Glucagon Injection) 1 mg Secondary objective (2):To compare the pharmacokinetics of G-Pen™ (glucagon injection) 1mg \[test\] administered as 0.5 mg and 1 mg injections, versus Lilly Glucagon™ (glucagon for injection \[rDNA origin\]) 1 mg (reference)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Texas Diabetes Institute, University Health System
San Antonio, Texas, United States
Serious Adverse Events
Number of serious adverse events (SAEs) per treatment group
Time frame: From first dose until completion of the post-treatment follow-up visit, up to 6 weeks
Glucose Area Under the Curve (AUC)
Pharmacodynamic parameter: Glucose area under the curve from baseline to 240 minutes post-treatment
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose Cmax
Pharmacodynamic parameter: Maximum concentration of glucose
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose Tmax
Pharmacodynamic parameter: Time to Maximum Glucose Concentration
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose AUCex
Pharmacodynamic parameter: Area Under the Glucose Excursion Curve
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose MAE
Pharmacodynamic parameter: Maximum absolute glucose excursion from baseline
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucose Tex
Pharmacodynamic parameter: Earliest reported time of MAE, based on within-subject changes from baseline
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Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucagon AUC
Pharmacokinetic parameter: Glucagon area under the curve from baseline to 240 minutes post-treatment
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucagon Cmax
Pharmacokinetic parameter: Maximum concentration of glucagon
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Glucagon Tmax
Pharmacokinetic parameter: Time to maximum concentration of glucagon
Time frame: Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection