A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human).

To assess the impact of inhalation of insulin on glucose disposition in patients with type 1 diabetes.

The registry classes the interventions as drug.

More on the Plan

The study was terminated on Oct. 28, 2007.

The protocol was undergoing implementation and methodological issues with major revisions that qualified this trial as a new trial.

Who Took Part

22 planned participants were the target.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Diabetes mellitus Type 1.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: asthma, copd.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2006-02 with completion listed for 2007-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 18F-labeled glucose uptake in muscle.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 22 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.