Effect of Exercise on the Absorption of Inhaled Human Insulin in Subjects With Type 1 Diabetes

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human).

The trial is conducted in Europe.

The registry classes the interventions as drug.

Who Took Part

23 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Type 1 diabetes more than or equal to 12 months. Body mass index (BMI) less than or equal to 29 kg/m2. Normal lung volumes. Treatment with intensified insulin therapy for at least 3 months.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: any present or history of pulmonary disease; impaired hepatic or renal function; cardiac problems.

How the Study Was Run

It was run as a randomized, crossover 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.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2005-10 with completion listed for 2005-11.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the plasma insulin profile in the interval (time frame: From 30-150 min after trial product administration).

It also tracked 4 secondary outcomes, for example Area under the plasma insulin profile in the interval from 120-240 min after trial product administration, Area under the plasma insulin profile in the interval from 240-360 min after trial product administration, Area under the plasma insulin profile in the interval 0-600 min after trial product administration and Maximum plasma insulin concentration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 23 people.

Its size is small, so on its own it can only give an early look.

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.