NCT02423980

G-Pen™ for Hypoglycemia Rescue in T1D Patients

G-Pen™ (Glucagon Injection) for Induced Hypoglycemia Rescue in Adult Patients With T1D

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Xeris Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, exploratory pilot study in patients with T1D. The study will involve two daytime clinical research center visits 7-14 days apart. Subjects will receive a single injection of G-Pen™ (glucagon injection) at each visit.

Detailed description

Following eligibility confirmation, each study participant will undergo two episodes of insulin-induced hypoglycemia with plasma glucose \< 50 mg/dL. Both episodes will be treated with a single subcutaneous injection of G-Pen™ glucagon. For the first treatment visit, all subjects will receive a 1 mg dose of G-Pen™ glucagon. The investigator will have discretion to repeat this same dose at the second treatment visit or give a 0.5 mg dose of G-Pen™ glucagon. A follow-up phone call will be conducted 3-7 days following administration of the final dose of study drug as a safety check.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	Glucagon

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2015-04-22
• Last updated: 2017-07-07
• Results posted: 2017-04-24

Locations

1 site across 1 country: United States