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

Hypoglycemia Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02459938
Study type Interventional
Source Zosano Pharma Inc.
Contact
Status Completed
Phase Phase 1
Start date January 2015
Completion date October 2015
View Details
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