A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma

What Was Tested

This registered phase 3 trial tested Insulin (regular human).

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma.

It had two arms (groups): Inhaled Insulin (experimental) and Subcutaneous Insulin (active comparator).

The registry classes the interventions as drug.

Who Took Part

288 actual participants took part.

It was open to people of any sex aged from 18 years up to 77 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin. Mild intermittent or mild to moderate persistent asthma.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

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

It started in 2003-01 with completion listed for 2008-10.

It ran at 102 sites in United States (86), Canada (10), Brazil (4), Costa Rica (1) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1) (time frame: Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52). Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco) (time frame: Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52). Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1) (time frame: Baseline through Week 52 Last Observation Carried Forward (LOCF)).

It also tracked 32 secondary outcomes, for example Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1), Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco), Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1), Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco), Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) and Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 288 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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