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

What Was Tested

The trial (phase 3) is built around Insulin (regular human).

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.

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

The registry classes the interventions as drug.

More on the Plan

At that time recruitment for study A2171030 was placed on hold.

Accordingly, there will be no commercial availability of Exubera.

As a result, study A2171030 was terminated on June 17, 2008.

Who Took Part

The registry lists 105 actual participants took part.

It was open to people of any sex aged from 30 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.

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

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2008-09.

It ran at 88 sites in United States (77), Canada (5), Brazil (4), Costa Rica (1) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (time frame: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52). Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco) (time frame: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52).

It also tracked 21 secondary outcomes, for example Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs), Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs), Other PFTs (Besides FEV1 and DLco), Bronchodilator Responsiveness as Determined by the Change in FEV1, Methacholine PC20 and Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 105 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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