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

Primary Purpose

Hypoglycemia

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

Glucagon (ZP-Glucagon)

Glucagon (GlucaGen)

About this trial

This is an interventional treatment trial for Hypoglycemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Nucleus Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

ZP-Glucagon 0.5 mg

ZP-Glucagon 1.0 mg

Glucagon by injection, 0.5 mg

Glucagon by injection, 1.0 mg

Arm 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

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

Outcomes

Primary Outcome Measures

Percentage of subjects achieving normoglycemia

Secondary Outcome Measures

Time at which normoglycemia is first reached

Time at which maximal glucose levels are reached

Increases in blood glucose by 15 minute intervals

Peak Plasma Concentration (Cmax)

Area under the plasma concentration versus time curve (AUC)

Full Information

NCT ID

NCT02459938

First Posted

May 21, 2015

Last Updated

August 14, 2016

Sponsor

Zosano Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02459938

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zosano Pharma Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoglycemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ZP-Glucagon 0.5 mg

Arm Type

Experimental

Arm 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

Arm Title

ZP-Glucagon 1.0 mg

Arm Type

Experimental

Arm 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

Arm Title

Glucagon by injection, 0.5 mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

Glucagon by injection, 1.0 mg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Glucagon (ZP-Glucagon)

Other Intervention Name(s)

glucagon

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Glucagon (GlucaGen)

Other Intervention Name(s)

glucagon

Intervention Description

recombinant glucagon administered via subcutaneous injection

Primary Outcome Measure Information:

Title

Percentage of subjects achieving normoglycemia

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Time at which normoglycemia is first reached

Time Frame

3 hours

Title

Time at which maximal glucose levels are reached

Time Frame

3 hours

Title

Increases in blood glucose by 15 minute intervals

Time Frame

3 hours

Title

Peak Plasma Concentration (Cmax)

Time Frame

3 hours

Title

Area under the plasma concentration versus time curve (AUC)

Time Frame

3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neale Cohen, MD

Organizational Affiliation

Baker ID Heart and Diabetes Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nucleus Network

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3005

Country

Australia

12. IPD Sharing Statement

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

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