Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Efficacy and Safety of Nasal Glucagon for Treatment of Insulin Induced Hypoglycemia in Adults With Diabetes
The purpose of this study is to assess the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and safety of 3 milligrams (mg) glucagon (glucagon nasal powder) administered nasally compared with commercially available glucagon given by intramuscular injection.
Each glucagon dosing visit was conducted after an overnight fast of at least 8 h with a
starting plasma glucose >= 90 mg/dL. Hypoglycemia was induced by an intravenous (IV) infusion
of regular insulin diluted in normal saline during the clinic visit. Five minutes after
stopping the insulin infusion (once the plasma glucose was <60 mg/dL), participants were
treated with either a 3 mg glucagon dose nasally or 1 mg of glucagon administered by
intramuscular (IM) injection.
After a wash-out period of 7 days or more, participants returned to the clinic and the
procedure repeated with each participant crossed over to the other treatment. As such, each
participant underwent two episodes of insulin-induced hypoglycemia in random order and
received glucagon nasal powder during one episode and commercially available glucagon
(GlucaGen, Novo Nordisk) by IM injection during the other episode.
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