HypoglycemiaPhase 1NCT02459938
Safety and Efficacy of ZP-Glucagon to Injectable Glucagon for Hypoglycemia
A Phase 1 study testing Glucagon (ZP-Glucagon) and Glucagon (GlucaGen) in people with Hypoglycemia, run by Zosano Pharma Corporation at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Glucagon (ZP-Glucagon) and Glucagon (GlucaGen)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2015to Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hypoglycemia
- Being tested
- Glucagon (ZP-Glucagon), Glucagon (GlucaGen)
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon (ZP-Glucagon)Drug
Also called glucagon
chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes
Glucagon (GlucaGen)Drug
Also called glucagon
recombinant glucagon administered via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Glucagon (GlucaGen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieving normoglycemia
Measured: 30 minutes
Secondary outcomes (5)
Time at which normoglycemia is first reached
Measured: 3 hours
Time at which maximal glucose levels are reached
Measured: 3 hours
Increases in blood glucose by 15 minute intervals
Measured: 3 hours
Peak Plasma Concentration (Cmax)
Measured: 3 hours
Area under the plasma concentration versus time curve (AUC)
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zosano Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neale Cohen, MD, Principal investigator, Baker ID Heart and Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459938
- Sponsor's protocol ID
- CP-2014-004
- Status last verified
- Aug 2016
- First submitted
- 21 May 2015
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02459938
- Acronym / sponsor ID
- CP-2014-004
- Conditions
- Hypoglycemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Zosano Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ZP-Glucagon 0.5 mg | Experimental | Drug: Glucagon (ZP-Glucagon)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 |
| ZP-Glucagon 1.0 mg | Experimental | Drug: Glucagon (ZP-Glucagon)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 by injection, 0.5 mg | Active comparator | Drug: Glucagon (GlucaGen)glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg |
| Glucagon by injection, 1.0 mg | Active comparator | Drug: Glucagon (GlucaGen)glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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%
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucagon (ZP-Glucagon)Also: glucagonchemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes | Drug | ZP-Glucagon 0.5 mg, ZP-Glucagon 1.0 mg |
| Glucagon (GlucaGen)Also: glucagonrecombinant glucagon administered via subcutaneous injection | Drug | Glucagon by injection, 0.5 mg, Glucagon by injection, 1.0 mg |
Primary outcome
Percentage of subjects achieving normoglycemia
Time frame: 30 minutes
5 secondary outcomes
Time at which normoglycemia is first reached
Time frame: 3 hours
Time at which maximal glucose levels are reached
Time frame: 3 hours
Increases in blood glucose by 15 minute intervals
Time frame: 3 hours
Peak Plasma Concentration (Cmax)
Time frame: 3 hours
Area under the plasma concentration versus time curve (AUC)
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
Related trials for Hypoglycemia
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingPhase 2
Effect of Mizagliflozin on Hypoglycemia in Patients With Post-Bariatric Hypoglycemia
Postbariatric Hypoglycemia
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neale Cohen, MD principal investigator
Baker ID Heart and Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glucagon (ZP-Glucagon) and Glucagon (GlucaGen) in people with Hypoglycemia, run by Zosano Pharma Corporation at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects achieving normoglycemia (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.