G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes
Status:
Completed
Trial end date:
2018-05-03
Target enrollment:
Participant gender:
Summary
This is a non-inferiority, 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 Lilly 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 hypoglycemia through IV administration of
regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose < 50
mg/dL is verified, the subject is administered a dose of G-Pen or Lilly Glucagon via
subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes
post-dosing, with a value of >70.0 mg/dL 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 procedure 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.