A Study Evaluating the Bioavailability of Oral Insulin (N11005)

What Was Tested

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

The objective of this study was to preliminarily verify whether the oral insulin N11005 is a prandial insulin by assessing the PK, PD, and safety profiles of N11005.

It had two arms (groups): T group (experimental) and R group (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 12 actual participants took part.

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

The set-up was randomized, crossover and open-label.

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

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 2019-12-10 with completion listed for 2020-08-14.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Cmax. AUC 0-8 h. AUCGIR,0-8 h.

It also tracked 8 secondary outcomes, for example Tmax, AUC 0-2 h, the elimination half-life (t1/2) of serum insulin, the AUC for insulin from time zero to 4 h, the AUC for insulin from time zero to infinite time and AUCGIR，0-2 h.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 12 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.