Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)

What Was Tested

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

This trial is conducted in Europe, Asia and South America.

A one-year clinical trial to compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with type 1 or type 2 diabetes and chronic obstructive pulmonary disease (COPD).

It had two arms (groups): A (experimental) and B (active comparator).

The registry classes the interventions as drug.

More on the Plan

The decision to discontinue the development of AERx® is not due to any safety concerns.

Who Took Part

38 actual participants took part.

It was open to people of any sex aged from 30 years with no upper age limit.

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

Examples of who could join: Chronic Obstructive Pulmonary Disease. Type 1 or type 2 diabetes. Body Mass Index (BMI) lower or equal to 40.0 kg/m2.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: recurrent severe hypoglycaemia; current smoking or smoking within the last 6 months; other pulmonary disease including asthma.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2007-05-15 with completion listed for 2008-03-05.

It ran at 27 sites in India (6), Turkey (Türkiye) (6), Slovakia (5), Argentina (3), Taiwan (3) and Romania (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections (time frame: After one year).

It also tracked 3 secondary outcomes, for example Patient Reported Outcomes and Diabetes control measured by change in HbA1c from baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Insulin Aspart in 38 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 and the Insulin Aspart compound page, all human trials.