G-Pen (Glucagon Injection) Compared to Lilly Glucagon (Glucagon for Injection [RDNA Origin]) for Induced Hypoglycemia Rescue in Adult Patients With T1DM: A Phase 3, Multi-center, Randomized, Blinded, 2-Way Crossover Study to Evaluate Efficacy and Safety
Status: Completed
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection \[rDNA origin\]) for hypoglycemia rescue of adult patients with type 1 diabetes.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• diagnosed with type 1 diabetes mellitus for at least 24 months
• usage of daily insulin treatment
• random serum C-peptide concentration \< 0.5 ng/mL
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
ProSciento, Inc.
Chula Vista
AMCR Institute
Escondido
Diablo Clinical Research
Walnut Creek
Texas
Clinical Trials of Texas, Inc.
San Antonio
Washington
Rainier Research
Renton
Other Locations
Canada
LMC Diabetes & Endocrinology
Toronto
Time Frame
Start Date: 2017-03-15
Completion Date: 2017-09-25
Participants
Target number of participants: 80
Treatments
Other: G-Pen first, then Lilly Glucagon
A single 1 mg subcutaneous (SC) injection of G-Pen (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection \[rDNA origin\])
Other: Lilly Glucagon first, then G-Pen
A single 1 mg SC injection of Lilly Glucagon (glucagon injection \[rDNA origin\]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen (glucagon injection)
Authors
Related Therapeutic Areas
Sponsors
Leads: Xeris Pharmaceuticals