Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma

What Was Tested

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

This trial is conducted in Europe, Asia, Oceania and the United States of America (USA).

This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.

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

10 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 1 or type 2 diabetes. Treatment with insulin and/or oral anti-diabetic drugs. Asthma for at least 6 months. Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years. Body Mass Index (BMI) less than or equal to 40.0 kg/m2.

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

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-08-30 with completion listed for 2008-02-28.

It ran at 32 sites in United States (9), Australia (8), India (6), Slovakia (5), Malaysia (3) and Serbia and Montenegro (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes in lung function, chest X-rays, or asthma exacerbation frequency (time frame: after 52 weeks of treatment).

It also tracked 3 secondary outcomes, for example Diabetes control measured by change in HbA1c and Laboratory assessments (biochemistry, insulin antibodies, blood count).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Insulin Aspart in 10 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.