The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to patients with type 1 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
19
single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
Oregon Health & Science University
Portland, Oregon, United States
Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)
The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.
Time frame: 0 to 150 minutes post-dosing
Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)
The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.
Time frame: 0 to 150 minutes post-dosing
Glucagon Cmax
Maximum plasma concentration of glucagon
Time frame: From 0 to 150 minutes post-dosing
Glucose Cmax
Maximum plasma concentration of glucose
Time frame: From 0 to 150 minutes post-dosing
Glucagon Tmax
Time to maximum plasma concentration of glucagon
Time frame: From 0 to 150 minutes post-dosing
Glucose Tmax
Time to maximum plasma concentration of glucose
Time frame: From 0 to 150 minutes post-dosing
Glucagon AUC
Area under the plasma concentration time curve for glucagon
Time frame: From 0 to 150 minutes post-dosing
Glucose AUC
Area under the plasma concentration time curve for glucose
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Time frame: From 0 to 150 minutes post-dosing
Infusion Site Discomfort Score at 10 Minutes
Infusion site discomfort was assessed by the subjects using a 100 mm Visual Analog Scale (VAS) questionnaire at 10 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.
Time frame: At 10 minutes post-dosing
Infusion Site Discomfort Score at 30 Minutes
Infusion site discomfort was assessed by the subject using a 100 mm Visual Analog Scale (VAS) questionnaire at 30 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.
Time frame: At 30 minutes post-dosing