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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02459938




Registration number
NCT02459938
Ethics application status
Date submitted
21/05/2015
Date registered
2/06/2015
Date last updated
16/08/2016

Titles & IDs
Public title
Safety and Efficacy of ZP-Glucagon to Injectable Glucagon for Hypoglycemia
Scientific 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
Secondary ID [1] 0 0
CP-2014-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoglycemia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Glucagon (ZP-Glucagon)
Treatment: Drugs - Glucagon (GlucaGen)

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

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

Active comparator: Glucagon by injection, 0.5 mg - glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg

Active comparator: Glucagon by injection, 1.0 mg - glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg


Treatment: Drugs: Glucagon (ZP-Glucagon)
chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes

Treatment: Drugs: Glucagon (GlucaGen)
recombinant glucagon administered via subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of subjects achieving normoglycemia
Timepoint [1] 0 0
30 minutes
Secondary outcome [1] 0 0
Time at which normoglycemia is first reached
Timepoint [1] 0 0
3 hours
Secondary outcome [2] 0 0
Time at which maximal glucose levels are reached
Timepoint [2] 0 0
3 hours
Secondary outcome [3] 0 0
Increases in blood glucose by 15 minute intervals
Timepoint [3] 0 0
3 hours
Secondary outcome [4] 0 0
Peak Plasma Concentration (Cmax)
Timepoint [4] 0 0
3 hours
Secondary outcome [5] 0 0
Area under the plasma concentration versus time curve (AUC)
Timepoint [5] 0 0
3 hours

Eligibility
Key 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%
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3005 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Zosano Pharma Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neale Cohen, MD
Address 0 0
Baker ID Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02459938