Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus.

What Was Tested

In this phase 2 trial, researchers set out to test Insulin (regular human).

This is a research study of a study drug known as LY041001 or human insulin inhalation powder (HIIP).

HIIP is a powder form of insulin made to be inhaled through the mouth and into the lungs using a special handheld device.

It had two arms (groups): A (experimental) and B (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 119 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: You are at least 18 years old. You have had type 1 diabetes for at least 2 years. You are injecting insulin lispro (Humalog), an insulin lispro mixture (Humalog Mixture), regular human insulin mixture (Humulin mixture) before meals using a syringe or injection pen, not an insulin pump. You have not smoked for at least 1 year, and you agree not to smoke or use smokeless tobacco during the study.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: you have used an experimental drug during the last 30 days or have ever taken part in a study of any type of inhaled insulin; you have a history of asthma or allergies; you have a chronic cough.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

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 2003-04 with completion listed for 2004-04.

It ran at 25 sites in United States (25).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example assess symptoms of diabetes, patient vitality, and patient satisfaction with the diabetes treatments, assess insulin inhaler reliability and assess patient compliance with the HIIP delivery system Directions for Use (DFU).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 119 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.