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

August 14, 2016 updated by: Zosano Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3005
        • Nucleus Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Glucagon (ZP-Glucagon)
chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes
Other Names:
  • glucagon
Experimental: 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
Drug: Glucagon (ZP-Glucagon)
chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes
Other Names:
  • glucagon
Active Comparator: Glucagon by injection, 0.5 mg
glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg
Drug: Glucagon (GlucaGen)
recombinant glucagon administered via subcutaneous injection
Other Names:
  • glucagon
Active Comparator: Glucagon by injection, 1.0 mg
glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg
Drug: Glucagon (GlucaGen)
recombinant glucagon administered via subcutaneous injection
Other Names:
  • glucagon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects achieving normoglycemia
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zosano Pharma Corporation

Investigators

  • Principal Investigator: Neale Cohen, MD, Baker ID Heart and Diabetes Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 21, 2015

First Submitted That Met QC Criteria

May 28, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 14, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-2014-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoglycemia

Clinical Trials on Glucagon (ZP-Glucagon)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe