Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose

What Was Tested

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

* Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug. * Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.

The registry classes the interventions as drug.

Who Took Part

The registry lists 626 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: Type 2 diabetes.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: type 1 diabetes.

How the Study Was Run

The set-up was 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.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2003-01 with completion listed for 2007-06.

It ran at 119 sites in United States (88), Canada (12), Mexico (9), Australia (7) and Brazil (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycosylated hemoglobin.

It also tracked 4 secondary outcomes, for example endpoints include, body weight, patient reported outcomes, incidence and severity, of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to and insufficient clinical response.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 626 people.

With 626 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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