NCT02656069

Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Xeris Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a blinded, randomized, Phase 3 comparative efficacy and safety study in adults with type 1 diabetes. Patients will complete screening procedures up to 60 days before randomization to determine eligibility before enrollment to the treatment phase. The procedure for evaluating the efficacy of the G-Pen (glucagon injection) consists of inducing hypoglycemia by intravenous administration of regular insulin diluted in normal saline. Each participant will undergo two episodes of insulin-induced hypoglycemia, and in random order will receive 1 mg G-Pen (glucagon injection) during one episode and 1 mg Lilly Glucagon during the other episode. There will be wash out period of 7-28 days between treatment visits. Blood glucose levels will be monitored post-dosing, with a return of plasma glucose to a concentration \> 70 mg/dL within 30 minutes signifying successful hypoglycemia rescue. As a confirmation of efficacy, subjects will complete a questionnaire concerning changes in symptoms of hypoglycemia following treatment with glucagon. Subjects will return for a follow-up safety visit 3-14 days following administration of the final dose of glucagon.

Conditions

• Hypoglycemia
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	G-Pen (glucagon injection)	1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
DRUG	Lilly Glucagon (glucagon injection [rDNA origin])	1 mg of Lilly glucagon reconstituted from lyophilized powder

Timeline

• Start date: 2017-03-15
• Primary completion: 2017-08-14
• Completion: 2017-09-25
• First posted: 2016-01-14
• Last updated: 2018-10-30
• Results posted: 2018-09-28

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study