Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested 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 or rosiglitazone treatment, both in combination with metformin and glimepiride.

It had two arms (groups): A (active comparator) 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: 227 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. Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months. BMI less than or equal to 40 kg/m2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: current smoking or smoking within the last 6 months; current acute or chronic pulmonary disease (except for asthma); proliferative retinopathy requiring acute treatment.

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.

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 2007-01-10 with completion listed for 2008-03-11.

It ran at 103 sites in United States (103).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (time frame: After 26 weeks).

It also tracked 5 secondary outcomes, for example Fasting plasma glucose, Lipid profiles, 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 227 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.