Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Lispro.

It had two arms (groups): Insulin Lispro (active comparator) and Exubera (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 191 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Adults with type 2 diabetes using Lantus® (insulin glargine) as their basal insulin, not at glycemic goal.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: lung disease; current smoking or discontinued smoking within past 6 months.

How the Study Was Run

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

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.

The Insulin Lispro group and the comparison group ran side by side rather than switching.

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

It started in 2006-06 with completion listed for 2008-08.

It ran at 63 sites in United States (62) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment (time frame: Baseline, Week 24 (End of Treatment)).

It also tracked 20 secondary outcomes, for example Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit, Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles, Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12, Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24, Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests and Change From Baseline Weight at Each Visit.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro in 191 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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