NCT00602914

A Pilot Study to Assess the Safety, PK and PD of Insulin Injected Via MicronJet or Conventional Needle

An Open Label Study in Healthy Volunteers and Diabetes Mellitus Type II Subjects to Determine the Safety, Pharmacokinetics and Pharmacodynamics Profile of Insulin Injected by the MicronJet Device

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: NanoPass Technologies Ltd · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle.

Detailed description

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.

Conditions

• Intradermal Injections

Interventions

Type	Name	Description
DEVICE	MicronJet	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.
DEVICE	MicronJet	MicronJet, Intradermal Injection

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-12-01
• Completion: 2009-07-01
• First posted: 2008-01-28
• Last updated: 2013-05-10