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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02459938

Enrollment

Registered

2015-06-02

Start date

2015-01-31

Completion date

2015-10-31

Last updated

2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycemia

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.

Interventions

DRUGGlucagon (ZP-Glucagon)

chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes

DRUGGlucagon (GlucaGen)

recombinant glucagon administered via subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of subjects achieving normoglycemia	30 minutes

Secondary

Measure	Time frame
Time at which normoglycemia is first reached	3 hours
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
Area under the plasma concentration versus time curve (AUC)	3 hours

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026