A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Lispro.

It had two arms (groups): Control (active comparator) and Experimental (experimental).

The registry classes the interventions as drug.

More on the Plan

At that time recruitment for study, A2171035 was placed on hold.

Accordingly, there will be no commercial availability of Exubera®.

As a result, study A2171035 was terminated on May 12, 2008.

Who Took Part

Enrollment: 58 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: Diabetes mellitus Type 1.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: severe asthma, severe chronic obstructive pulmonary disease (copd).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Insulin Lispro 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.

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2006-11 with completion listed for 2008-06.

It ran at 23 sites in Belgium (3), France (3), United Kingdom (3), United States (2), Austria (2) and Spain (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%) (time frame: At 52 weeks).

It also tracked 13 secondary outcomes, for example Change From Baseline in FPG, Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments, Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments, Change From Baseline in Insulin Antibody Levels, Change From Baseline in Body Weight and Change From Baseline in Body Mass Index.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Lispro in 58 people.

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

More context: the Insulin Lispro compound page, all human trials.