Comparison of the Effect on the Glucose Infusion Rates Between Inhaled Technosphere Insulin and a Subcutaneous Injection of Regular Human Insulin

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human).

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Subcutaneous regular human insulin (active comparator).

The registry classes the interventions as drug.

Who Took Part

12 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: Subjects must be in good health, as judge by brief history and physical examination. Sex: both, male and female. Age: 18-40 years. Body mass index: 18-27 kg/m2. Capability to reach peak inspiratory flow of \>41/sec measured by a computer assisted spirometry.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: diabetes mellitus type 1 or type 2; human insulin antibodies; anamnestic history of hypersensitivity to the study medication or to drugs with similar chemical structures.

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 1999-08 with completion listed for 2000-02.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the glucose infusion rate for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment (time frame: crossover every 3-28 days for up to 20 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 12 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 (regular human) compound page, all human trials.