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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Glucagon by injection, 0.5 mg | Active Comparator | glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg |
|
| Glucagon by injection, 1.0 mg | Active Comparator | glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucagon (ZP-Glucagon) | Drug | chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving normoglycemia | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neale Cohen, MD | Baker ID Heart and Diabetes Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | 3005 | Australia |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005934 | Glucagon |
| D052216 | Glucagon-Like Peptide 1 |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Glucagon (GlucaGen) | Drug | recombinant glucagon administered via subcutaneous injection |
|
|
| 3 hours |
| Peak Plasma Concentration (Cmax) | 3 hours |
| Area under the plasma concentration versus time curve (AUC) | 3 hours |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004763 | Glucagon-Like Peptides |
| D005768 | Gastrointestinal Hormones |