Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler

What Was Tested

This registered phase 1 trial tested Insulin (regular human).

The registry classes the interventions as drug.

Who Took Part

14 planned participants were the target.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Non smoking for at least 12 months. BMI equal to or less than 28. Willing to participate and to sign informed consent form.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: positive results for insulin antibodies at screening; history of substance abuse or dependency within last 5 years; positive screening test for substance abuse.

How the Study Was Run

The set-up was randomized, crossover 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.

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

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

It started in 2007-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: maximum insulin serum concentration. Tmax. AUC.

It also tracked 5 secondary outcomes, for example maximum glucose infusion rate, Tmax and AUC.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 14 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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