NCT02459938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

May 21, 2015

Last Update Submit

August 14, 2016

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects achieving normoglycemia

    30 minutes

Secondary Outcomes (5)

  • 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

Study Arms (4)

ZP-Glucagon 0.5 mg

EXPERIMENTAL

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)

ZP-Glucagon 1.0 mg

EXPERIMENTAL

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)

Glucagon by injection, 0.5 mg

ACTIVE COMPARATOR

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

Drug: Glucagon (GlucaGen)

Glucagon by injection, 1.0 mg

ACTIVE COMPARATOR

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

Drug: Glucagon (GlucaGen)

Interventions

Glucagon (ZP-Glucagon)DRUG

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

Also known as: glucagon
ZP-Glucagon 0.5 mgZP-Glucagon 1.0 mg
Glucagon (GlucaGen)DRUG

recombinant glucagon administered via subcutaneous injection

Also known as: glucagon
Glucagon by injection, 0.5 mgGlucagon by injection, 1.0 mg

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3005, Australia

Location

MeSH Terms

Conditions

Hypoglycemia

Interventions

GlucagonGlucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProglucagonPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsGlucagon-Like PeptidesGastrointestinal Hormones

Study Officials

  • Neale Cohen, MD

    Baker ID Heart and Diabetes Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2015

First Posted

June 2, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

AU(1)