Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes

What Was Tested

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

This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus.

The other name for this inhaled insulin is Exubera®.

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin.

It had two arms (groups): Inhaled Insulin (experimental) and Subcutaneous insulin (active comparator).

Inhalable short-acting insulin.

The registry classes the interventions as drug.

More on the Plan

Accordingly, there will be no commercial availability of Exubera.

As a result, study A2171029 was terminated on June 9, 2008.

Who Took Part

Enrollment: 635 actual participants took part.

It was open to people of any sex aged from 35 years up to 75 years.

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

Examples of who could join: Type 2 diabetes mellitus.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: smoking pregnancy.

How the Study Was Run

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

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.

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 2002-06 with completion listed for 2008-12.

It ran at 92 sites in United States (69), Canada (16), Puerto Rico (5) and Brazil (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1) (time frame: Month 3 through extension Month 60). Change From Baseline in FEV1 (time frame: Baseline through extension follow up Month 3). Annual Rate of Change in FEV1 (time frame: Week -2 through extension follow up Month 3 or end of study).

It also tracked 18 secondary outcomes, for example Forced Vital Capacity (FVC), Total Lung Capacity (TLC), Change From Baseline in Glycosylated Hemoglobin (HbA1c), Change From Baseline in Fasting Plasma Glucose (FPG), Change From Baseline in Body Weight and Total Daily Long-acting Insulin (Adjusted for Body Weight).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 635 people.

With 635 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.