NCT02081001

PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients

Comparison of Pharmacokinetic and Pharmacodynamic Profiles of G-Pump™ (Glucagon Infusion) vs. GlucaGen® Delivered Subcutaneously to Subjects With Type 1 Diabetes (T1DM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Xeris Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to patients with type 1 diabetes.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	Novo Nordisk GlucaGen®	single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
DRUG	G-Pump™ (glucagon infusion)	single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2014-03-07
• Last updated: 2018-04-06
• Results posted: 2016-08-01

Locations

1 site across 1 country: United States