Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

What Was Tested

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

This trial is conducted in Asia, Europe and Oceania.

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

Enrollment: 363 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 2 diabetes. Treated with OAD(s) for more than or equal to 2 months. Body mass index (BMI) less than or equal to 40.0 kg/m2.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: recurrent major hypoglycaemia; current smoking or smoking within the last 6 months; impaired hepatic or renal function.

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.

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 2006-10-10 with completion listed for 2008-03-10.

It ran at 26 sites in Russia (6), India (5), Turkey (Türkiye) (5), Australia (4), Philippines (3) and Croatia (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Treatment difference in HbA1c (time frame: After 26 weeks).

It also tracked 5 secondary outcomes, for example Adverse events, Body weight, Lung function, Blood glucose and Hypoglycaemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 363 people.

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.