NCT02459938

Safety and Efficacy of ZP-Glucagon to Injectable Glucagon for Hypoglycemia

A Randomized Open-label Crossover Study to Compare the Safety and Efficacy of ZP-Glucagon to Injectable Glucagon in the Treatment of Insulin-induced Hypoglycemia in Subjects With Type-1 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Zosano Pharma Corporation · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether glucagon administered by microneedle patch is comparable to glucagon administered by injection pen in the treatment of insulin-induced hypoglycemia.

Detailed description

The purpose of this study is to compare ZP-Glucagon transdermal patch system at doses of 0.5 mg and 1 mg to glucagon by injection at doses of 0.5 mg and 1 mg by means of a 4 way crossover open label design. Eligible subjects giving informed consent will be randomised to a treatment sequence of each of the four treatments in one week intervals. At each treatment visit, subjects will undergo an insulin induction procedure designed to safely induce hypoglycemia, and then have a treatment applied, either by injection or by patch, and then monitored for return to normoglycemia.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	Glucagon (ZP-Glucagon)	chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes
DRUG	Glucagon (GlucaGen)	recombinant glucagon administered via subcutaneous injection

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-08-01
• Completion: 2015-10-01
• First posted: 2015-06-02
• Last updated: 2016-08-16

Locations

1 site across 1 country: Australia