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 Details — Status: Completed

Administrative data

• NCT number: NCT02459938
• Other study ID #: CP-2014-004
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2015
• Last updated: August 14, 2016
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: August 2016
• Source: Zosano Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women or men 18 to 60 years with type-1 diabetes on daily insulin treatment (basal-bolus injection regimen or insulin pump) for at least two years, on a total daily dose that has been stable for the last 3 months preceding enrollment (no more than 20% variation), and with a current level of glycated hemoglobin between 6.5% and 10%

Exclusion Criteria:

• Any history of hypoglycemic coma or hypoglycemic seizures.

• Any episode of severe hypoglycemia (requiring treatment) within one month prior to study start.

• Any history of pheochromocytoma or insulinoma

Study Design

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

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Drug:
• Glucagon (ZP-Glucagon)
chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes
• Glucagon (GlucaGen)
recombinant glucagon administered via subcutaneous injection

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Zosano Pharma Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects achieving normoglycemia		30 minutes	Yes
Secondary	Time at which normoglycemia is first reached		3 hours	Yes
Secondary	Time at which maximal glucose levels are reached		3 hours	Yes
Secondary	Increases in blood glucose by 15 minute intervals		3 hours	Yes
Secondary	Peak Plasma Concentration (Cmax)		3 hours	Yes
Secondary	Area under the plasma concentration versus time curve (AUC)		3 hours	Yes