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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
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 website
https://clinicaltrials.gov/study/NCT02459938
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02459938