G-Pen™ for Hypoglycemia Rescue in T1D Patients

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xeris Pharmaceuticals
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• Type 1 diabetes mellitus for at least 24 months

Exclusion Criteria:

• Pregnant or Lactating

• HbA1c >10.5% at screening

• Use of > 2.0 U/kg total insulin dose per day

• Inadequate bilateral venous access in both arms

• Renal insufficiency

• Congestive heart failure, NYHA class II, III or IV

• Active malignancy within 5 years from screening

• Major surgical operation within 30 days prior to screening

• Seizure or bleeding disorder

• Glycogen storage disease

• Active substance or alchohol abuse