Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin (regular human).

This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus.

The drug is called EXUBERA (inhaled insulin).

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): Subcutaneous Insulin (active comparator) and Inhaled Insulin (experimental).

The registry classes the interventions as drug.

More on the Plan

Accordingly, there will be no commercial availability of Exubera.

As a result, study A2171022 was terminated on June 9, 2008.

Who Took Part

582 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Type 1 diabetes mellitus.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: severe asthma or copd; brittle diabetes.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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 2002-05 with completion listed for 2008-12.

It ran at 73 sites in United States (36), Canada (21), Brazil (8), Argentina (4) and Mexico (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (time frame: Baseline through Extension Follow-up Month 3). Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) (time frame: Baseline through Extension Follow-up Month 3). Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1) (time frame: Week -2 through Extension Follow-up Month 6 or end of study).

It also tracked 16 secondary outcomes, for example Change From Baseline in Glycosylated Hemoglobin (HbA1c), Hypoglycemic Event Rates, Severe Hypoglycemic Event Rates, Change From Baseline in Fasting Plasma Glucose, Change From Baseline Body Weight and Baseline Dyspnea Index (BDI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 582 people.

With 582 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.