Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology

What Was Tested

The trial (phase 4) is built around Insulin Lispro.

Needle-free jet injector provides an alternative for patients with diabetes treated by insulin.

It had two arms (groups): Needle-free jet injection (experimental) and Conventional pen (experimental).

Jet injectors deliver insulin at a high velocity (typically.100 m/s) across the skin in the subcutaneous tissue and may dispense the insulin over a larger area than insulin injected with a syringe.

Conventional insulin administration with insulin pens.

The registry classes the interventions as device.

More on the Plan

This is a randomized, double-blind, double-dummy, crossover study.

Eighteen healthy volunteers will be recruited.

PK-PD profiles of lispro will be calculated.

Who Took Part

The registry lists 18 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: The range of height should be 170±10cm. Liver and renal function should be normal. Health subjects with no chronic diseases or medications.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: drug allergy, history of allergic disorders or allergies; A history of liver or kidney disease; smoker, drinkers.

How the Study Was Run

Design: randomized, crossover and triple-blind.

The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Lispro.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2015-04 with completion listed for 2015-09.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Early insulin exposure (time frame: The area under the curve (AUC) of insulin from 0 to 30min (AUCins, 0-30min)).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Lispro in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Lispro compound page, all human trials.