A study examining the injection of insulin into layers of the skin (compared to conventional injection under the skin) by an injector device named Med-Jet H4

A Pilot Study Examining the Feasibility of Intradermal Insulin Injection by an Injector Device (Med-Jet H4) in Healthy Adults.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000253909

Enrollment

Registered

2020-02-26

Start date

2020-03-02

Completion date

2020-09-07

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Intradermal delivery of insulin has been shown to be safe, well tolerated and to improve the pharmacokinetics of rapid insulin analogs compared with conventional subcutaneous administration in patients with type 1 diabetes and type 2 diabetes as well as in healthy individuals. It is associated with more rapid insulin absorption with faster time to maximum insulin concentration and faster offset of action compared to subcutaneous insulin administration. Med-Jet H4 (Medical International Technologies Canada, Montreal, Quebec, Canada) is a needle-free injector device which can deliver the drugs intradermally. The Purpose of this study is to compare the pharmacokinetics, pharmacodynamics, safety and tolerability of insulin aspart delivered by intradermal injection with Med-Jet H4 device versus subcutaneous injection with FlexPen® in healthy non-diabetic individuals.

Interventions

Intervention involves a single intradermal injection with Med-Jet H4 device of 10 units of insulin aspart (Novorapid; Novo Nordisk) in healthy non-diabetic individuals. Med-Jet H4 (Medical International Technologies Canada, Montreal, Quebec, Canada) is a needle-free injector device which can inject the drugs intradermally.. Injection will be performed by a trained nurse and is a one-off injection. This is a cross-over study with a 2-week wash-out period between treatments.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

- Healthy non-diabetic adult volunteers - BMI: 18-27 kg/m2

Exclusion criteria

- Diabetes or pre-diabetes as confirmed by HbA1C > 5.6% - Dermatological conditions at the injection sites that may interfere with insulin absorption - Pregnancy - Glucocorticoid use within 7 days of inclusion (excluding inhaled or topical steroid)

Outcome results