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

Phase 1

Completed

• Conditions: Hypoglycemia
• Interventions: Drug: Glucagon (ZP-Glucagon); Drug: Glucagon (GlucaGen)

• Registration Number: NCT02459938
• Lead Sponsor: Zosano Pharma Corporation

Brief 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-05-21
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-02
• Primary Completion: 2015-08
• Study Completion: 2015-10
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-14
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ZP-Glucagon 1.0 mg	Glucagon (ZP-Glucagon)	glucagon applied to the ZP transdermal microneedle patch system at a dose of 1.0 mg applied by means of a purpose built reusable applicator and worn for 30 minutes
Glucagon by injection, 1.0 mg	Glucagon (GlucaGen)	glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg
ZP-Glucagon 0.5 mg	Glucagon (ZP-Glucagon)	glucagon applied to the ZP transdermal microneedle patch system at a dose of 0.5 mg applied by means of a purpose built reusable applicator and worn for 30 minutes
Glucagon by injection, 0.5 mg	Glucagon (GlucaGen)	glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg

Primary Outcome Measures

Name	Time	Method
Percentage of subjects achieving normoglycemia	30 minutes

Secondary Outcome Measures

Name	Time	Method
Time at which maximal glucose levels are reached	3 hours
Increases in blood glucose by 15 minute intervals	3 hours
Peak Plasma Concentration (Cmax)	3 hours
Time at which normoglycemia is first reached	3 hours
Area under the plasma concentration versus time curve (AUC)	3 hours

Trial Locations

Locations (1)

Nucleus Network; 🇦🇺 Melbourne, Victoria, Australia