Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.

What Was Tested

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

To assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.

The registry classes the interventions as drug.

Who Took Part

345 planned participants were the target.

It was open to people of any sex aged from 35 years up to 80 years.

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

Examples of who could join: Type 2 Diabetes Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: asthma, copd; smoking during the previous 6 months.

How the Study Was Run

The set-up was 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 1999-06 with completion listed for 2000-09.

It ran at 52 sites in United States (37) and Canada (15).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values.

It also tracked 7 secondary outcomes, for example Meal glucose response measured at Week -1 and at Week 12;, not the subject's home glucose monitoring results and Comparison of 24-hour home glucose profiles.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 345 people.

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.