G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
Status:
Completed
Trial end date:
2019-04-02
Target enrollment:
Participant gender:
Summary
This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and
safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime
clinical research center (CRC) visits with random assignment to receive G-Pen glucagon 1 mg
during one period and Novo Glucagon 1 mg during the other. Each daytime visit is preceded by
an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is
brought into a state of severe hypoglycemia through IV administration of regular insulin
diluted in normal saline. After a hypoglycemic state with plasma glucose < 54 mg/dL (3
mmol/L) is verified, the subject is administered a dose of G-Pen or Novo Glucagon via
subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes
post-dosing, with a value of >70.0 mg/dL (3.89 mmol/L) or an increase of > 20 mg/dL (>1.11
mmol/L) within 30 minutes of glucagon administration indicating a positive response. After 3
hours, the subject is given a meal and discharged when medically stable. After a wash-out
period of 7 to 28 days, subjects return to the CRC, and the procedures are repeated with each
subject crossed over to the other treatment. A follow-up visit as a safety check is conducted
2-7 days following administration of the final dose of study drug.