NCT03439072

G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes

G-Pen™ (Glucagon Injection) Compared to Lilly Glucagon (Glucagon for Injection [RDNA Origin]) for Induced Hypoglycemia Rescue in Adults With T1D: a Phase 3 B Multi-Centered, Randomized, Controlled, Single Blind, 2-Way Crossover Study to Evaluate Efficacy and Safety

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Xeris Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insulin Hypoglycemia
• Type 1 Diabetes Mellitus
• Severe Hypoglycemia

Interventions

Type	Name	Description
DRUG	G-Pen	1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
DRUG	Lilly Glucagon	1 mg subcutaneous injection of Lilly Glucagon (glucagon injection \[RNDA Origin\])

Timeline

• Start date: 2018-01-23
• Primary completion: 2018-04-18
• Completion: 2018-05-03
• First posted: 2018-02-20
• Last updated: 2020-02-17
• Results posted: 2019-05-30

Locations

6 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study