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

Zosano Pharma

Status and phase

Completed

Phase 1

Conditions

Hypoglycemia

Treatments

Drug: Glucagon (ZP-Glucagon)

Drug: Glucagon (GlucaGen)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02459938

CP-2014-004

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 4 patient groups

ZP-Glucagon 0.5 mg

Experimental group

Description:

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

Treatment:

Drug: Glucagon (ZP-Glucagon)

ZP-Glucagon 1.0 mg

Experimental group

Description:

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

Treatment:

Drug: Glucagon (ZP-Glucagon)

Glucagon by injection, 0.5 mg

Active Comparator group

Description:

glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg

Treatment:

Drug: Glucagon (GlucaGen)

Glucagon by injection, 1.0 mg

Active Comparator group

Description:

glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg