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The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle.
Administration of insulin to the skin has many potential advantages including improved kinetics and reduced pain. Today, insulin is injected to the SQ space, using, in most cases, various devices incorporating standard metal needles and usually causing considerable pain and discomfort to the patients. NanoPass has developed a microneedle based needle substitute for intradermal injections. This device requires minimal expertise and is expected to cause minimal or no pain during injections.
The objective of this study is to compare the pharmacokinetics and pharmacodynamics of insulin Novorapid® (Novo Nordisk) injected via the MicronJet device intradermally, to a conventional needle injected to the SQ space.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 10 healthy volunteers will receive 0.1 U/kg. Once administered with a conventional needle (SQ) and then with MicronJet needle (ID) in a randomized order |
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| 2 | Experimental | 10 Type II DM subject will receive 0.2 U/kg. Once administered with a conventional needle (SQ) and then with MicronJet needle (ID) in a randomized order |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicronJet | Device | The micronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the skin). In this study the MicronJet will be used to inject insulin vs. a convention needle injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood samples for PK and PD will be collected | pre dose and up to 360 minutes post dose of administration |
| Measure | Description | Time Frame |
|---|---|---|
| Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires | All study duration |
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A. Healthy volunteers
Inclusion Criteria:
Exclusion Criteria:
B. Type 2 diabetic patients
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Itamar Raz, MD | Head, Diabetes Unit, Hadassah Medical Organization, Jerusalem, Israel | Principal Investigator |
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| MicronJet | Device | MicronJet, Intradermal Injection |
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