Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes

What Was Tested

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

This trial is conducted in the United States of America (USA).

This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone.

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

The registry lists 196 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. Current treatment with oral antidiabetes drugs (OADs) for at least 2 months. BMI less than or equal to 40 kg/m2.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: current regular smoking or regular smoking within the last 6 months; current acute or chronic pulmonary disease (except for asthma); proliferative retinopathy requiring treatment.

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.

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

It started in 2006-11-29 with completion listed for 2008-03-18.

It ran at 110 sites in United States (110).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c change from baseline (time frame: After 26 weeks of treatment).

It also tracked 5 secondary outcomes, for example Fasting plasma glucose, Lipid profiles, Frequency of hypoglycaemic episodes, Glucose profiles and Change in body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 196 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.