PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD

What Was Tested

This registered phase 2 trial tested Insulin (regular human) and Insulin Lispro.

Target population will be Non-Diabetic individuals with mild to moderate asthma or chronic obstructive pulmonary disease (COPD) and non-diabetic individuals without underlying lung disease (healthy subjects).

It had two arms (groups): one (experimental) and Insulin Lispro (active comparator).

Insulin Lispro (Humalog®) will be administered by subcutaneous injection.

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 30 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

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

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.

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 2018-02-06 with completion listed for 2019-07-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the insulin curve (AUC) (time frame: 10 hours). Area under the glucose infusion rate curve (GIR) (time frame: 10 hours).

It also tracked 1 secondary outcome, for example Area under the insulin curve following inhalation of salbutamol.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) and Insulin Lispro in 40 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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