The purpose of this study is to determine whether glucagon administered by microneedle patch is comparable to glucagon administered by injection pen in the treatment of insulin-induced hypoglycemia.
The purpose of this study is to compare ZP-Glucagon transdermal patch system at doses of 0.5 mg and 1 mg to glucagon by injection at doses of 0.5 mg and 1 mg by means of a 4 way crossover open label design. Eligible subjects giving informed consent will be randomised to a treatment sequence of each of the four treatments in one week intervals. At each treatment visit, subjects will undergo an insulin induction procedure designed to safely induce hypoglycemia, and then have a treatment applied, either by injection or by patch, and then monitored for return to normoglycemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes
recombinant glucagon administered via subcutaneous injection
Nucleus Network
Melbourne, Victoria, Australia
Percentage of subjects achieving normoglycemia
Time frame: 30 minutes
Time at which normoglycemia is first reached
Time frame: 3 hours
Time at which maximal glucose levels are reached
Time frame: 3 hours
Increases in blood glucose by 15 minute intervals
Time frame: 3 hours
Peak Plasma Concentration (Cmax)
Time frame: 3 hours
Area under the plasma concentration versus time curve (AUC)
Time frame: 3 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.