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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZP-Glucagon 0.5 mg

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

Group Type EXPERIMENTAL

Glucagon (ZP-Glucagon)

Intervention Type DRUG

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

ZP-Glucagon 1.0 mg

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

Group Type EXPERIMENTAL

Glucagon (ZP-Glucagon)

Intervention Type DRUG

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

Glucagon by injection, 0.5 mg

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

Group Type ACTIVE_COMPARATOR

Glucagon (GlucaGen)

Intervention Type DRUG

recombinant glucagon administered via subcutaneous injection

Glucagon by injection, 1.0 mg

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

Group Type ACTIVE_COMPARATOR

Glucagon (GlucaGen)

Intervention Type DRUG

recombinant glucagon administered via subcutaneous injection

Interventions

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Glucagon (ZP-Glucagon)

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

Intervention Type DRUG

Glucagon (GlucaGen)

recombinant glucagon administered via subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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glucagon glucagon

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No