Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes

What Was Tested

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

To determine in subjects with Type 1 Diabetes Mellitus: 1.

The treatment regimens differ only by the route of delivery of the short acting insulin. 2.

The registry classes the interventions as drug.

Who Took Part

The registry lists 320 planned participants were the target.

It was open to people of any sex aged from 12 years up to 65 years.

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

Examples of who could join: Type 1 Diabetes for more than 1 year. Stable insulin regimen of at least 2 injections per day.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: any smoking within the last 6 months. smoking is not permitted at any time during this study; subjects on insulin pump during 2 months prior to screening.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 1999-05 with completion listed for 2000-10.

It ran at 35 sites in United States (30) and Canada (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Primary outcome is 24 week change in baseline in HbA1c.

It also tracked 10 secondary outcomes, for example Incidence of hypoglycemia, Change from baseline in fasting lipid profile, Change from baseline in fasting plasma glucose level, Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose), Change from baseline in body weight and Patient satisfaction and preference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 320 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.